Ibuprofen and Pseudoephedrine hydrochloride

Manufacturer: Bryant Ranch Prepack
Effective date: 2024-01-11
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1002
Source: legacy-cache
Hydrated at: 2026-08-01 21:14:51

Label at a glance#

ProductIbuprofen and Pseudoephedrine hydrochloride

Active ingredientIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE

Label structure11 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: Ohm Laboratories Inc.
North Brunswick, NJ 08902

HOW SUPPLIED

HOW SUPPLIED SECTION

NDC: 63629-5284-1: 30 Tablets in a BOTTLE

NDC: 63629-5284-2: 20 Tablets in a BOTTLE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ibuprofen/ Pseudoephedrine 200/30 Tab.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-5284-1	2022-02-16	C162847	48780-1	9855e2a2-3f51-60a7-e053-dbdaa90a05bd	Ibuprofen and Pseudoephedrine hydrochloride
63629-5284-2	2022-02-16	C162847	48780-1	9855e2a2-3f51-60a7-e053-dbdaa90a05bd	Ibuprofen and Pseudoephedrine hydrochloride
63629-5284-1	2019-11-27	C162847	48780-1	9855e2a2-3f51-60a7-e053-dbdaa90a05bd	Ibuprofen and Pseudoephedrine hydrochloride
63629-5284-2	2019-11-27	C162847	48780-1	9855e2a2-3f51-60a7-e053-dbdaa90a05bd	Ibuprofen and Pseudoephedrine hydrochloride

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	1000
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	1000
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	1000
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	1000
ACACIA	INACTIVE INGREDIENT	5C5403N26O	1000
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	1000
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1000
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1000
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	1000
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	1000
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1000
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1000
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	1000
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1000
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	1000
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	1000
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	1000
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1000
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	1000
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	1000
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1000
SHELLAC	INACTIVE INGREDIENT	46N107B71O	1000
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1000
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1000
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1000
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1000
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1000
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	1000

Products#

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

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

Ibuprofen and Pseudoephedrine hydrochloride
ACACIA
CALCIUM CARBONATE
CARNAUBA WAX
STARCH, CORN
CROSCARMELLOSE SODIUM
CROSPOVIDONE (120 .MU.M)
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
KAOLIN
POVIDONE, UNSPECIFIED
POWDERED CELLULOSE
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM BENZOATE
SUCROSE
TALC
TITANIUM DIOXIDE
WHITE WAX
GUAR GUM
FERROSOFERRIC OXIDE
POLYETHYLENE GLYCOL, UNSPECIFIED
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
IBUPROFEN
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
63629-5284	63629-5284-1, 63629-5284-2
51660-423

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 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 (120 .MU.M)	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
KAOLIN	24H4NWX5CO	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
POWDERED CELLULOSE	SMD1X3XO9M	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
GUAR GUM	E89I1637KE	IACT
FERROSOFERRIC OXIDE	XM0M87F357	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED	9XZ8H6N6OH	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
PSEUDOEPHEDRINE HYDROCHLORIDE	6V9V2RYJ8N	ACTIB

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 6 · 329 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii+route 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER / ORAL		602 mg	Exact identifier — unii+route 34 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 20 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, DELAYED RELEASE / ORAL		66 mg	Exact identifier — unii+route 22 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, DELAYED RELEASE / ORAL	0.02 mg		Exact identifier — unii+route 25 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii+route 22 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	GRANULE, EFFERVESCENT / ORAL	60 mg		Exact identifier — unii+route 19 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii+route 19 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii+route 22 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / ORAL		22602 mg	Exact identifier — unii+route 20 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	DROPS / ORAL	0.2 mg/1ml		Exact identifier — unii+route 25 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii+route 21 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	ELIXIR / ORAL	5.02 mg/5ml		Exact identifier — unii+route 19 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, COATED / ORAL	3 mg		Exact identifier — unii+route 7 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED / ORAL	NA		Exact identifier — unii+route 22 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 22 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	TABLET, COATED / ORAL	13.6 mg		Exact identifier — unii+route 19 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii+route 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, EXTENDED RELEASE / ORAL		67 mg	Exact identifier — unii+route 22 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii+route 21 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	GRANULE, FOR SOLUTION / ORAL		42596 mg	Exact identifier — unii+route 31 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii+route 19 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SYRUP / ORAL	4 mg/5ml		Exact identifier — unii+route 25 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii+route 31 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	POWDER, FOR SUSPENSION / ORAL		200 mg	Exact identifier — unii+route 19 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 9 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, FILM COATED / ORAL	1 mg		Exact identifier — unii+route 25 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE, COATED PELLETS / ORAL		198 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, FILM COATED / ORAL		145 mg	Exact identifier — unii+route 31 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, ORALLY DISINTEGRATING / ORAL		12 mg	Exact identifier — unii+route 25 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, COATED / ORAL	40.2 mg		Exact identifier — unii+route 11 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	POWDER, FOR SOLUTION / ORAL		280 mg	Exact identifier — unii+route 34 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii+route 19 equally ranked IID candidates
POVIDONES	POVIDONE	FZ989GH94E	POWDER, FOR SUSPENSION / ORAL	35 mg/5ml		Exact identifier — unii+route 21 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii+route 22 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii+route+dosage form
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	SUSPENSION / ORAL	100 mg/5ml		Exact identifier — unii+route 22 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii+route 22 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET / ORAL	30 mg		Exact identifier — unii+route 19 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii+route 19 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SOLUTION / ORAL		98 mg	Exact identifier — unii+route 19 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	CAPSULE / ORAL		257 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	PASTE / ORAL		28 mg	Exact identifier — unii+route 19 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, DELAYED RELEASE / ORAL		955 mg	Exact identifier — unii+route 31 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER / ORAL	800 mg		Exact identifier — unii+route 15 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 25 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii+route 7 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	SUSPENSION / ORAL		150 mg	Exact identifier — unii+route 20 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii+route 34 equally ranked IID candidates
FERROSOFERRIC OXIDE	FERROSOFERRIC OXIDE	XM0M87F357	CAPSULE, EXTENDED RELEASE / ORAL	1.49 mg		Exact identifier — unii+route 10 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, COATED / ORAL	0.2 mg		Exact identifier — unii+route 19 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	TABLET, FILM COATED / ORAL		300 mg	Exact identifier — unii+route 10 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	ELIXIR / ORAL	5.4 mg/5ml		Exact identifier — unii+route 25 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	DROPS / ORAL	NA		Exact identifier — unii+route 11 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	TABLET, COATED / ORAL	516.42 mg		Exact identifier — unii+route 31 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii+route 25 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, DELAYED RELEASE / ORAL	30 mg		Exact identifier — unii+route 15 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED / ORAL		17 mg	Exact identifier — unii+route 22 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 · 2 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	Ohm Laboratories Inc.	65ec0f85-7ca3-4adc-b152-a0ae2fd0692f	2025-02-27	Warnings	Exact identifier ndc (product): 51660-423
8628adae-722a-4fb1-b066-6696e5ed951b			7249b0f9-b24c-4f7f-81f2-22473a4d5b0c	2024-01-15	Warnings	Exact identifier spl set id: 7249b0f9-b24c-4f7f-81f2-22473a4d5b0c

Reported adverse events (FAERS/openFDA)#

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