Advil Allergy and Congestion Relief

Manufacturer: Haleon US Holdings LLC
Effective date: 2025-04-09
Label type: HUMAN OTC DRUG LABEL
Version: 26
Source: full-release
Hydrated at: 2026-06-01 00:58:54

Label at a glance#

ProductAdvil Allergy and Congestion Relief

Active ingredientCHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE

Label structure11 sections

Indications and uses

• temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: • runny nose • itchy, watery eyes • itching of the nose or throat • sneezing • nasal congestion • sinus pressure • headache • minor body aches and pains • fever • reduces swelling of the nasal passages • temporarily restores freer breathing through the nose

Dosage and administration

• do not take more than directed • adults and children 12 years of age and over: • take 1 tablet every 4 hours while symptoms persist • do not take more than 6 tablets in any 24-hour period, unless directed by a doctor • children under 12 years of age: do not use because this product contains too much medication for children under this age

Storage and handling

• read all warnings and directions before use. Keep carton. • store at 20-25°C (68-77°F) • avoid excessive heat above 40°C (104°F)

Contacts and useful links#

PhoneLabel contact1-800-88-ADVIL

Websitewww.advil.com

www.advil.com

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Chlorpheniramine maleate 4 mg

Ibuprofen 200 mg (NSAID)*

Phenylephrine HCl 10 mg

* nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Antihistamine

Pain reliever/Fever reducer

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
- runny nose
- itchy, watery eyes
- itching of the nose or throat
- sneezing
- nasal congestion
- sinus pressure
- headache
- minor body aches and pains
- fever
reduces swelling of the nasal passages
temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

SPL UNCLASSIFIED SECTION

hives
facial swelling
asthma (wheezing)
shock
skin reddening
rash
blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

SPL UNCLASSIFIED SECTION

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

SPL UNCLASSIFIED SECTION

Do not use

OTC - DO NOT USE SECTION

in children under 12 years of age because this product contains too much medication for children under this age
if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have a breathing problem such as emphysema or chronic bronchitis
stomach bleeding warning applies to you
you have problems or serious side effects from taking pain relievers or fever reducers
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, glaucoma, have trouble urinating due to an enlarged prostate gland, or had a stroke.
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

under a doctor's care for any serious condition
taking sedatives or tranquilizers
taking any other product that contains phenylephrine, chlorpheniramine or any other nasal decongestant or antihistamine
taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
taking any other drug

When using this product

OTC - WHEN USING SECTION

take with food or milk if stomach upset occurs
avoid alcoholic drinks
be careful when driving a motor vehicle or operating machinery
drowsiness may occur
alcohol, sedatives, and tranquilizers may increase drowsiness
may cause excitability especially in children

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience any of the following signs of stomach bleeding:
- feel faint
- vomit blood
- have bloody or black stools
- have stomach pain that does not get better
you have symptoms of heart problems or stroke:
- chest pain
- trouble breathing
- weakness in one part or side of body
- slurred speech
- leg swelling
pain gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
nasal congestion lasts for more than 7 days
redness or swelling is present in the painful area
you get nervous, dizzy, or sleepless
symptoms continue or get worse
any new symptoms appear

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
adults and children 12 years of age and over:
- take 1 tablet every 4 hours while symptoms persist
- do not take more than 6 tablets in any 24-hour period, unless directed by a doctor
children under 12 years of age: do not use because this product contains too much medication for children under this age

Other information

STORAGE AND HANDLING SECTION

read all warnings and directions before use. Keep carton.
store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, artificial flavors, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, glycerin, glyceryl dibehenate, hypromellose, lactic acid, lecithin, maltodextrin, medium-chain triglycerides, microcrystalline cellulose, pharmaceutical ink, polydextrose, polyvinyl alcohol, pregelatinized starch, propyl gallate, silicon dioxide, sucralose, synthetic iron oxide, talc, titanium dioxide, triacetin, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call weekdays from 9 AM to 5 PM EST toll free at 1-800-88-ADVIL

Additional Information

SPL UNCLASSIFIED SECTION

READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATION

Product inside sealed in plastic blister with foil backing.
Do Not Use if plastic blister or foil barrier is broken.

For most recent product information,

visit www.advil.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil

ALLERGY &
CONGESTION RELIEF

Chlorpheniramine Maleate 4 mg Antihistamine
Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
Phenylephrine HCl 10 mg Nasal Decongestant

Sneezing
Nasal Congestion
Sinus Pressure
Nasal Swelling
Runny Nose
Headache
Fever
Body Aches

Advil
A&CR

ONE
PILL
DOSE!

10 Coated Tablets

PAA147206 Carton Front

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advil

ALLERGY &
CONGESTION RELIEF

Chlorpheniramine Maleate 4 mg Antihistamine
Ibuprofen 200 mg Pain Reliever/Fever Reducer (NSAID)
Phenylephrine HCl 10 mg Nasal Decongestant

50%
MORE
10 FREE
Tablets

Sneezing
Nasal Congestion
Sinus Pressure
Nasal Swelling
Runny Nose
Headache
Fever
Body Aches
Advil

Advil
A&CR

ONE
TABLET
DOSE!

30 Coated Tablets

000066065 Carton Front

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1310503	Chlorpheniramine/Ibuprofen/Phenylephrine (Oral Pill)	chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1310503	chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	26
1310503	chlorpheniramine maleate 4 MG / ibuprofen 200 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	26

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CHLORPHENIRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813
IBUPROFEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
f6d1b8d7-3bd1-4248-eddd-b60565c88015	Product name	4	20230808
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
d17a97fa-387f-690e-d2be-0083ab044a03	Product name	3	20170725
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
c6fba691-a132-4ede-95c6-f8c6bd696636	Product name	1	20150902
c0200ab5-4954-454e-9676-30b741b245bd	Product name	1	20150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0573-0196-01	2024-01-31	C162847	48780-1	1030e364-fc70-111a-e063-dadaa90a10e2	Drug Facts
0573-0196-02	2024-01-31	C162847	48780-1	1030e364-fc70-111a-e063-dadaa90a10e2	Drug Facts
0573-0196-10	2024-01-31	C162847	48780-1	1030e364-fc70-111a-e063-dadaa90a10e2	Drug Facts
0573-0196-20	2024-01-31	C162847	48780-1	1030e364-fc70-111a-e063-dadaa90a10e2	Drug Facts
0573-2161-03	2024-01-31	C162847	48780-1	1030e364-fc70-111a-e063-dadaa90a10e2	Drug Facts
0573-0196-01	2024-01-30	C162847	48780-1	1030e364-fc70-111a-e063-dadaa90a10e2	Drug Facts
0573-0196-02	2024-01-30	C162847	48780-1	1030e364-fc70-111a-e063-dadaa90a10e2	Drug Facts
0573-0196-10	2024-01-30	C162847	48780-1	1030e364-fc70-111a-e063-dadaa90a10e2	Drug Facts
0573-0196-20	2024-01-30	C162847	48780-1	1030e364-fc70-111a-e063-dadaa90a10e2	Drug Facts
0573-2161-03	2024-01-30	C162847	48780-1	1030e364-fc70-111a-e063-dadaa90a10e2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0573-0196-01	Advil Allergy and Congestion Relief	50 in 1 TRAY	TABLET, COATED	50	26
0573-0196-01	Advil Allergy and Congestion Relief	1 in 1 PACKET	TABLET, COATED	1	26
0573-0196-02	Advil Allergy and Congestion Relief	1 in 1 PACKET	TABLET, COATED	1	26
0573-0196-02	Advil Allergy and Congestion Relief	2 in 1 CARTON	TABLET, COATED	2	26
0573-0196-10	Advil Allergy and Congestion Relief	10 in 1 BLISTER PACK	TABLET, COATED	10	26
0573-0196-10	Advil Allergy and Congestion Relief	1 in 1 CARTON	TABLET, COATED	1	26
0573-0196-20	Advil Allergy and Congestion Relief	10 in 1 BLISTER PACK	TABLET, COATED	10	26
0573-0196-20	Advil Allergy and Congestion Relief	2 in 1 CARTON	TABLET, COATED	2	26
0573-2161-03	Advil Allergy and Congestion Relief	10 in 1 BLISTER PACK	TABLET, COATED	10	26
0573-2161-03	Advil Allergy and Congestion Relief	2 in 1 CARTON	TABLET, COATED	2	26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0573-0196	ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HALEON US HOLDINGS LLC]	26	Current NDC, Legacy NDC, 8 package rows	20250410_a6cc97d8-252a-4527-a470-6d9e356342fd.zip
0573-2161	ADVIL ALLERGY AND CONGESTION RELIEF (CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HALEON US HOLDINGS LLC]	26	Current NDC, Legacy NDC, 2 package rows	20250410_a6cc97d8-252a-4527-a470-6d9e356342fd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-0196-01	EA - Each	0573-0196	9d14018e-d877-4eef-85c7-31c9376c8d98	1	2016-05-16
0573-0196-10	EA - Each	0573-0196	fd9744d0-f04f-434a-804a-bda9e470cfe0	1	2013-02-13
0573-0196-20	EA - Each	0573-0196	cc6b0675-9eef-4bbb-b743-6c202410d3f0	1	2016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CHLORPHENIRAMINE MALEATE	ACTIVE INGREDIENT	V1Q0O9OJ9Z	4
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	4
PHENYLEPHRINE HYDROCHLORIDE	ACTIVE INGREDIENT	04JA59TNSJ	4
CHLORPHENIRAMINE	ACTIVE MOIETY	3U6IO1965U	4
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	4
PHENYLEPHRINE	ACTIVE MOIETY	1WS297W6MV	4
ACESULFAME POTASSIUM	INACTIVE INGREDIENT	23OV73Q5G9	4
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	4
EGG PHOSPHOLIPIDS	INACTIVE INGREDIENT	1Z74184RGV	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	4
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	4
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	4
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	4
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	4
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	4
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	4
PROPYL GALLATE	INACTIVE INGREDIENT	8D4SNN7V92	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	4
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	4
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 29 matching rows.

Advil Allergy and Congestion Relief
chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride
CHLORPHENIRAMINE MALEATE
CHLORPHENIRAMINE
IBUPROFEN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE
ACESULFAME POTASSIUM
CARNAUBA WAX
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
GLYCERIN
GLYCERYL DIBEHENATE
HYPROMELLOSE, UNSPECIFIED
LACTIC ACID, UNSPECIFIED FORM
EGG PHOSPHOLIPIDS
MALTODEXTRIN
MEDIUM-CHAIN TRIGLYCERIDES
MICROCRYSTALLINE CELLULOSE
POLYDEXTROSE
POLYVINYL ALCOHOL, UNSPECIFIED
PROPYL GALLATE
SUCRALOSE
FERRIC OXIDE RED
TALC
TITANIUM DIOXIDE
TRIACETIN
XANTHAN GUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0573-0196	0573-0196-01, 0573-0196-10, 0573-0196-20, 0573-0196-02
0573-2161	0573-2161-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 50 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CHLORPHENIRAMINE MALEATE	V1Q0O9OJ9Z	ACTIB
IBUPROFEN	WK2XYI10QM	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCERYL DIBEHENATE	R8WTH25YS2	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
LACTIC ACID, UNSPECIFIED FORM	33X04XA5AT	IACT
EGG PHOSPHOLIPIDS	1Z74184RGV	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
PROPYL GALLATE	8D4SNN7V92	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
XANTHAN GUM	TTV12P4NEE	IACT
CHLORPHENIRAMINE MALEATE	V1Q0O9OJ9Z	ACTIB
IBUPROFEN	WK2XYI10QM	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCERYL DIBEHENATE	R8WTH25YS2	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
LACTIC ACID, UNSPECIFIED FORM	33X04XA5AT	IACT
EGG PHOSPHOLIPIDS	1Z74184RGV	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 10 · 588 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii+route 133 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, FILM COATED / ORAL	0.08 mg		Exact identifier — unii+route 133 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	TABLET / ORAL	ADJ PH		Exact identifier — unii+route 28 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SOLUTION / ORAL		800 mg	Exact identifier — unii+route 126 equally ranked IID candidates
GLYCERYL DIBEHENATE	GLYCERYL DIBEHENATE	R8WTH25YS2	TABLET, COATED / ORAL		19 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINE	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, COATED / ORAL		920 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	LOZENGE / ORAL		115 mg	Exact identifier — unii+route 126 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii+route 126 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	SUSPENSION / ORAL		160 mg	Exact identifier — unii+route 91 equally ranked IID candidates
POLYDEXTROSE	POLYDEXTROSE	VH2XOU12IE	TABLET, FILM COATED / ORAL		18 mg	Exact identifier — unii+route 21 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	SOLUTION / ORAL		5566 mg	Exact identifier — unii+route 49 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM, SOLUBLE / ORAL		33 mg	Exact identifier — unii+route 126 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, EXTENDED RELEASE / ORAL		528 mg	Exact identifier — unii+route 133 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	POWDER, FOR SUSPENSION / ORAL	45 mg/5ml		Exact identifier — unii+route 91 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	FILM, SOLUBLE / ORAL		10 mg	Exact identifier — unii+route 91 equally ranked IID candidates
PROPYL GALLATE	PROPYL GALLATE	8D4SNN7V92	TABLET / ORAL		7 mg	Exact identifier — unii+route 42 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	TABLET, COATED / ORAL	0.7 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TROCHE / ORAL		26 mg	Exact identifier — unii+route 91 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route 133 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, CHEWABLE / ORAL		15 mg	Exact identifier — unii+route 91 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET, EXTENDED RELEASE / ORAL	0.37 mg		Exact identifier — unii+route 49 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	TABLET, EXTENDED RELEASE / ORAL	0.37 mg		Exact identifier — unii+route 49 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii+route 133 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	TABLET, COATED / ORAL	0.7 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
PROPYL GALLATE	PROPYL GALLATE	8D4SNN7V92	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii+route 42 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii+route 133 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii+route 133 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	TABLET / ORAL	ADJ PH		Exact identifier — unii+route 28 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, EFFERVESCENT / ORAL		4 mg	Exact identifier — unii+route 91 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TABLET, EFFERVESCENT / ORAL		4 mg	Exact identifier — unii+route 91 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SOLUTION / ORAL	10 mg/5ml		Exact identifier — unii+route 133 equally ranked IID candidates
POLYDEXTROSE	POLYDEXTROSE	VH2XOU12IE	TABLET / ORAL		20 mg	Exact identifier — unii+route 21 equally ranked IID candidates
POLYDEXTROSE	POLYDEXTROSE	VH2XOU12IE	TABLET, EXTENDED RELEASE / ORAL		22 mg	Exact identifier — unii+route 21 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	SUSPENSION / ORAL		383 mg	Exact identifier — unii+route 126 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii+route 133 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii+route 133 equally ranked IID candidates
PROPYL GALLATE	PROPYL GALLATE	8D4SNN7V92	CONCENTRATE / ORAL	0.2 mg/1ml		Exact identifier — unii+route 42 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii+route 133 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii+route 133 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, EXTENDED RELEASE / ORAL		528 mg	Exact identifier — unii+route 133 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		2350 mg	Exact identifier — unii+route 133 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii+route 133 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, COATED / ORAL	320.75 mg		Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	FILM / ORAL		1 mg	Exact identifier — unii+route 126 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET / ORAL		45 mg	Exact identifier — unii+route 126 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 7 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii+route 133 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii+route 133 equally ranked IID candidates
ACESULFAME POTASSIUM	ACESULFAME POTASSIUM	23OV73Q5G9	TROCHE / ORAL		26 mg	Exact identifier — unii+route 91 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii+route 133 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, EFFERVESCENT / ORAL		1080 mg	Exact identifier — unii+route 126 equally ranked IID candidates
LACTIC ACID	LACTIC ACID	33X04XA5AT	SOLUTION / ORAL		192 mg	Exact identifier — unii+route 28 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	POWDER, FOR SUSPENSION / ORAL		600 mg	Exact identifier — unii+route 133 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii+route 133 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	PASTE / ORAL		1050 mg	Exact identifier — unii+route 133 equally ranked IID candidates
POLYDEXTROSE	POLYDEXTROSE	VH2XOU12IE	TABLET, FILM COATED / ORAL		18 mg	Exact identifier — unii+route 21 equally ranked IID candidates
SUCRALOSE	SUCRALOSE	96K6UQ3ZD4	TABLET, CHEWABLE / ORAL		28 mg	Exact identifier — unii+route 126 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	4MG;200MG;10MG	TABLET / ORAL		RLD, RS	2011-12-21
N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE	4MG;200MG;10MG	TABLET / ORAL		RLD, RS	2017-04-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022113-001	ADVIL ALLERGY AND CONGESTION RELIEF	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2011-12-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022113-002	ADVIL MULTI-SYMPTOM COLD & FLU	4MG;200MG;10MG	TABLET / ORAL	RLD, RS	2017-04-28	`74a2ff9319b5…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Advil Allergy and Congestion Relief	CHLORPHENIRAMINE MALEATE, IBUPROFEN, AND PHENYLEPHRINE HYDROCHLORIDE	Haleon US Holdings LLC	a6cc97d8-252a-4527-a470-6d9e356342fd	2025-04-09	Warnings	Exact identifier ndc (package): 0573-0196-02 ndc (package): 0573-0196-20 ndc (package): 0573-0196-10 ndc (package): 0573-2161-03 ndc (package): 0573-0196-01 ndc (product): 0573-2161 ndc (product): 0573-0196 ndc11 (package): 00573019620 ndc11 (package): 00573216103 ndc11 (package): 00573019610 ndc11 (package): 00573019602 ndc11 (package): 00573019601 spl id: ac233de1-41cf-4ef0-a7b4-30f395c88c1a spl set id: a6cc97d8-252a-4527-a470-6d9e356342fd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Advil Allergy and Congestion Relief

Label at a glance#

Indications and uses

Dosage and administration

Storage and handling

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

Purposes

Uses

Warnings

Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

OTC - PREGNANCY OR BREAST FEEDING SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

Other information

Inactive ingredients

Questions or comments?

Additional Information

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

Orange Book application contexts#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#