Ibuprofen and Pseudoephedrine Hydrochloride

Manufacturer: Strategic Sourcing Services LLC | Ohm Laboratories Inc | Ohm Laboratories Inc.
Effective date: 2024-11-22
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-06-01 00:38:47

Label at a glance#

ProductIbuprofen and Pseudoephedrine Hydrochloride

Active ingredientIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE

Label structure10 sections

Indications and uses

temporarily relieves these symptoms associated with the common cold or flu: headache fever sinus pressure nasal congestion minor body aches and pains

Dosage and administration

do not take more than directed the smallest effective dose should be used adults and children 12 years of age and over: take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used. do not use more than 6 caplets in any 24-hour period unless directed by a doctor children under 12 years of age: do not use

Storage and handling

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

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-406-7984

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each caplet)	Purposes
Ibuprofen, USP 200 mg (NSAID) ^*	Pain reliever/fever reducer
Pseudoephedrine HCl, USP 30 mg	Nasal decongestant

* nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms associated with the common cold or flu:

headache
fever
sinus pressure
nasal congestion
minor body aches and pains

Warnings

WARNINGS SECTION

Allergy alert

SPL UNCLASSIFIED SECTION

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

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

SPL UNCLASSIFIED SECTION

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

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

in children under 12 years of 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

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, 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 any other product that contains pseudoephedrine or any other nasal decongestant
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

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
fever gets worse or lasts more than 3 days
nasal congestion lasts for more than 7 days
symptoms continue or get worse
redness or swelling is present in the painful area
you get nervous, dizzy, or sleepless
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 during the last 3 months of 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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
the smallest effective dose should be used
adults and children 12 years of age and over:
- take 1 caplet every 4 to 6 hours while symptoms persist. If symptoms do not respond to 1 caplet, 2 caplets may be used.
- do not use more than 6 caplets in any 24-hour period unless directed by a doctor
children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, calcium carbonate, carnauba wax, confectioner's sugar, corn starch, croscarmellose sodium, crospovidone, FD&C Blue no. 2 Aluminum Lake, FD&C Red no. 40 Aluminum Lake, FD&C Yellow no. 6 Aluminum Lake, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, iron oxide black, kaolin, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, propylene glycol, shellac, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax

Questions?

OTC - QUESTIONS SECTION

call 1-800-406-7984

SPL UNCLASSIFIED SECTION

Distributed by McKesson
6555 State Highway 121
Irving, TX 75039

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 62011-0070-1

Health Mart_®

Compare to Advil ^®Cold & Sinus
active ingredients ^†

NON-DROWSY

Cold & Sinus

Ibuprofen and Pseudoephedrine
HCl Tablets, USP

Ibuprofen, USP 200 mg – Pain Reliever/Fever Reducer (NSAID)*
Pseudoephedrine HCl, USP 30 mg – Nasal Decongestant

*nonsteroidal anti-inflammatory drug

Relieves Sinus Pressure,
Nasal Congestion and Fever

ACTUAL SIZE

20Coated Caplets**
(**oval-shaped tablets)

SEE NEW WARNINGS INFORMATION

PRINCIPAL DISPLAY PANEL - 20 Caplet Blister Pack Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1299021	ibuprofen 200 MG / pseudoephedrine HCl 30 MG Oral Tablet	PSN	5
1299021	ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
IBUPROFEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108
PSEUDOEPHEDRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1e73f975-1ce7-705e-2bcf-788b1b5e24ba	Product name	5	20251124
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
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
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
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62011-0070-1	Ibuprofen and Pseudoephedrine Hydrochloride	20 in 1 BLISTER PACK	TABLET, SUGAR COATED	20		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62011-0070	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [STRATEGIC SOURCING SERVICES LLC]	5	Current NDC, Legacy NDC, 1 package rows	20241123_d93ae778-e6e9-4d1d-8f46-c04d962a9393.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62011-0070-1	EA - Each	62011-0070	4b0fcd92-a6e0-4006-9bc4-f957d8ea9eac	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	2
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	2
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	2
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	2
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	2
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	2
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	2
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	2
STARCH, PREGELATINIZED CORN	INACTIVE INGREDIENT	O8232NY3SJ	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
TRISTEARIN	INACTIVE INGREDIENT	P6OCJ2551R	2
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	2

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

Ibuprofen and Pseudoephedrine Hydrochloride
ACACIA
CALCIUM CARBONATE
CARNAUBA WAX
STARCH, CORN
CROSCARMELLOSE SODIUM
CROSPOVIDONE (15 MPA.S AT 5%)
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
GUAR GUM
GLYCERYL TRISTEARATE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
FERROSOFERRIC OXIDE
KAOLIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POWDERED CELLULOSE
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM BENZOATE
SUCROSE
TALC
TITANIUM DIOXIDE
WHITE WAX
IBUPROFEN
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
62011-0070	62011-0070-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACACIA	5C5403N26O	IACT
CALCIUM CARBONATE	H0G9379FGK	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
CROSPOVIDONE (15 MPA.S AT 5%)	68401960MK	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN, UNSPECIFIED	2G86QN327L	IACT
GUAR GUM	E89I1637KE	IACT
GLYCERYL TRISTEARATE	P6OCJ2551R	IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
KAOLIN	24H4NWX5CO	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POWDERED CELLULOSE	SMD1X3XO9M	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SUCROSE	C151H8M554	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WHITE WAX	7G1J5DA97F	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB

Source Document#

Source XML · Source PDF

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 12 · 700 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii+route 38 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, CHEWABLE / ORAL		180 mg	Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii+route 38 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, FILM COATED / ORAL		2 mg	Exact identifier — unii+route 18 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii+route 44 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	TABLET, COATED / ORAL	NA		Exact identifier — unii+route 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii+route 68 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		350 mg	Exact identifier — unii+route 42 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii+route 30 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION, EXTENDED RELEASE / ORAL		24 mg	Exact identifier — unii+route 38 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, FILM COATED / ORAL	131.67 mg		Exact identifier — unii+route 38 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, EXTENDED RELEASE / ORAL	4.59 mg		Exact identifier — unii+route 50 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET / ORAL		793 mg	Exact identifier — unii+route 20 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, EXTENDED RELEASE / ORAL		864 mg	Exact identifier — unii+route 38 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, DELAYED RELEASE / ORAL		53 mg	Exact identifier — unii+route 42 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	POWDER, FOR SUSPENSION / ORAL	35 mg/5ml		Exact identifier — unii+route 42 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii+route 40 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, COATED / ORAL	3.17 mg		Exact identifier — unii+route 50 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii+route 68 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route 62 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii+route 62 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	LIQUID / ORAL	NA		Exact identifier — unii+route 20 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	LIQUID / ORAL		37500 mg	Exact identifier — unii+route 62 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 38 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET / ORAL		230 mg	Exact identifier — unii+route 38 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii+route 50 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	TABLET, DELAYED RELEASE / ORAL		713 mg	Exact identifier — unii+route 38 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER, FOR SOLUTION / ORAL		40 mg	Exact identifier — unii+route 50 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / ORAL		660 mg	Exact identifier — unii+route 38 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	TABLET, EXTENDED RELEASE / ORAL	2.78 mg		Exact identifier — unii+route 18 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, CHEWABLE / ORAL		7258 mg	Exact identifier — unii+route 62 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii+route 38 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii+route 38 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii+route 44 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	POWDER / ORAL		244 mg	Exact identifier — unii+route 38 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / ORAL	75.3 mg/15ml		Exact identifier — unii+route 50 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii+route 68 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET / ORAL		7 mg	Exact identifier — unii+route 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii+route 44 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER / ORAL	800 mg		Exact identifier — unii+route 30 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, ORALLY DISINTEGRATING / ORAL		4 mg	Exact identifier — unii+route 38 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, FILM COATED / ORAL	0.14 mg		Exact identifier — unii+route 30 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii+route 44 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, COATED / ORAL	64.8 mg		Exact identifier — unii+route 20 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii+route 38 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii+route 38 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, EXTENDED RELEASE / ORAL		101 mg	Exact identifier — unii+route 42 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, DELAYED RELEASE / ORAL		6 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET / ORAL		4249 mg	Exact identifier — unii+route 62 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii+route 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii+route 68 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	SUSPENSION / ORAL	4.93 mg/5ml		Exact identifier — unii+route 20 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	CAPSULE, DELAYED RELEASE / ORAL	0.22 mg		Exact identifier — unii+route 18 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii+route 38 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route 38 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, EXTENDED RELEASE / ORAL		168 mg	Exact identifier — unii+route 68 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii+route 38 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii+route 38 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074567-001	IBUPROHM COLD AND SINUS	IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE	200MG;30MG	TABLET / ORAL			2001-04-17

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`f41ea6bd6efb…`

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
Ibuprofen and Pseudoephedrine Hydrochloride	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	d93ae778-e6e9-4d1d-8f46-c04d962a9393	2024-11-22	Warnings	Exact identifier ndc (package): 62011-0070-1 ndc (product): 62011-0070 ndc11 (package): 62011007001 spl id: 277a8bf7-fead-7d5d-e063-6294a90aed0d spl set id: d93ae778-e6e9-4d1d-8f46-c04d962a9393

Reported adverse events (FAERS/openFDA)#

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