Ibuprofen and Pseudoephedrine Hydrochloride

Manufacturer: Chain Drug Marketing Association Inc. | Ranbaxy Pharmaceuticals Inc. | Ohm Laboratories Inc.
Effective date: 2012-09-12
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:33:39

Label at a glance#

ProductIbuprofen and Pseudoephedrine Hydrochloride

Active ingredientIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

Temporarily relieves these symptoms associated with the common cold or flu: fever sinus pressure nasal congestion headache 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

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-406-7984

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS (IN EACH CAPLET)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen, USP 200 mg (NSAID)^*

Pseudoephedrine HCl, USP 30 mg

^*nonsteroidal anti-inflammatory drug

PURPOSES

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Nasal decongestant

USES

INDICATIONS & USAGE SECTION

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

fever
sinus pressure
nasal congestion
headache
minor body aches and pains

WARNINGS

WARNINGS SECTION

Allergy alert: 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: 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

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to any other pain reliever/fever reducer
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.
in children under 12 years of age
right before or after heart surgery

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 or have trouble urinating due to an enlarged prostate gland
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 drug
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

When using this product

OTC - WHEN USING SECTION

take with food or milk if stomach upset occurs
the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better

symptoms continue or get worse
any new symptoms appear
you get nervous, dizzy, or sleepless
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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

SPL UNCLASSIFIED 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.
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QC QUALITY CHOICE_®

NDC 63868-453-20

^*Compare to the active ingredients in Advil^®Cold & Sinus

NON-DROWSY

IBUPROFEN AND PSEUDOEPHEDRINE HCl TABLETS, USP

Cold & Sinus Formula

Ibuprofen, USP 200 mg - Pain Reliever/Fever Reducer (NSAID)^٭

Pseudoephedrine HCl, USP 30 mg - Nasal Decongestant

FOR RELIEF OF:

Sinus Pressure
Nasal Congestion
Fever

20 COATED CAPLETS^†(^†Oval-Shaped Tablets)

^٭nonsteroidal anti-inflammatory drug

^©DISTRIBUTED BY QUALITY CHOICE

5089124/R0811

This is the 20 count blister carton label for Quality Choice Ibuprofen and Pseudoephedrine HCl Tablets, USP.

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	2
1299021	ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	2

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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
874f4e63-49d2-5150-5d77-052172814ebd	Product name	6	20230105
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63868-453-20	2020-01-31	C162847	48780-1	9d75b9d1-16c8-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-453-20	Ibuprofen and Pseudoephedrine Hydrochloride	20 in 1 BLISTER PACK	TABLET, SUGAR COATED	20		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-453	IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [CHAIN DRUG MARKETING ASSOCIATION INC.]	2	Legacy NDC, 1 package rows	20121114_093e6388-54f2-4d04-ba55-8f7c9c182a0e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-453-20	EA - Each	63868-453	18807e03-5d45-416e-90bf-79d792592f80	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 · 31 matching rows.

Ibuprofen and Pseudoephedrine Hydrochloride
IBUPROFEN
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE
ACACIA
CALCIUM CARBONATE
CARNAUBA WAX
STARCH, CORN
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GUAR GUM
TRISTEARIN
HYDROXYPROPYL CELLULOSE
FERROSOFERRIC OXIDE
KAOLIN
POLYETHYLENE GLYCOLS
POWDERED CELLULOSE
POVIDONE
STARCH, PREGELATINIZED CORN
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM BENZOATE
SUCROSE
TALC
TITANIUM DIOXIDE
WHITE WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63868-453	63868-453-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB
ACACIA	5C5403N26O	IACT
CALCIUM CARBONATE	H0G9379FGK	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
CROSPOVIDONE	68401960MK	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
GELATIN	2G86QN327L	IACT
GUAR GUM	E89I1637KE	IACT
TRISTEARIN	P6OCJ2551R	IACT
HYDROXYPROPYL CELLULOSE	RFW2ET671P	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
KAOLIN	24H4NWX5CO	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	IACT
POWDERED CELLULOSE	SMD1X3XO9M	IACT
POVIDONE	FZ989GH94E	IACT
STARCH, PREGELATINIZED CORN	O8232NY3SJ	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

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 11 · 657 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	DROPS / ORAL	NA		Exact identifier — unii candidate 16 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL		13 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, DELAYED RELEASE / ORAL	16 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / ORAL		38 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE / ORAL		5785 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	DROPS / ORAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	GRANULE, FOR SUSPENSION / ORAL		296 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SOLUTION / DENTAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	SUSPENSION / ORAL		100 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET / ORAL		216 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
STARCH, PREGELATINIZED CORN	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CONCENTRATE / ORAL		7000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, FILM COATED / ORAL		330 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	14 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	LOZENGE / ORAL		120 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, COATED / ORAL	13.6 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
FD&C BLUE NO. 2	FD&C BLUE NO. 2	L06K8R7DQK	CAPSULE, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYSTEM / TOPICAL		2 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GEL / TOPICAL		5 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION/ DROPS / TOPICAL	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, ORALLY DISINTEGRATING / ORAL	15.03 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION/ DROPS / ORAL		90 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, LIQUID FILLED / ORAL		106 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		69 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUSPENSION / ORAL		113 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	POWDER, FOR SUSPENSION / ORAL	35 mg/5ml		Exact identifier — unii candidate 30 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, LIQUID FILLED / ORAL		1042 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE, DELAYED RELEASE / ORAL		1791 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, EXTENDED RELEASE / ORAL	1.49 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET / RECTAL	32.4 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	GEL / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL		350 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, EXTENDED RELEASE / ORAL	229.7 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / INTRAVENOUS	5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, EXTENDED RELEASE / ORAL		619 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, EXTENDED RELEASE / ORAL	14 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET / BUCCAL	1.1 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, DELAYED RELEASE PELLETS / ORAL		32 mg	Exact identifier — unii candidate 30 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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A074567-001	IBUPROHM COLD AND SINUS	200MG;30MG	TABLET / ORAL	2001-04-17	`c2088c7a36db…`
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…`

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
9b971e5f-98b5-4030-96d0-2b8aa5c03609			093e6388-54f2-4d04-ba55-8f7c9c182a0e	2012-09-12	Warnings	Exact identifier spl id: 9b971e5f-98b5-4030-96d0-2b8aa5c03609 spl set id: 093e6388-54f2-4d04-ba55-8f7c9c182a0e

Reported adverse events (FAERS/openFDA)#

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