Good Neighbor Pharmacy Ibuprofen Cold and Sinus

Manufacturer: Dispensing Solutions, Inc. | PSS World Medical, Inc.
Effective date: 2013-06-05
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:35:39

Label at a glance#

ProductGood Neighbor Pharmacy Ibuprofen Cold and Sinus

Active ingredientIBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE

Label structure9 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 contact1-800-719-9260

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen, USP 200 mg (NSAID)*

Pseudoephedrine HCl, USP 30 mg

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Nasal decongestant

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: 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 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
vomit blood
have bloody or black stools
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

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, FD&C red no. 40, FD&C yellow no. 6, gelatin, guar gum, hydrogenated vegetable oil, hydroxypropyl cellulose, kaolin, pharmaceutical ink, polyethylene glycol, powdered cellulose, povidone, pregelatinized starch, silicon dioxide, sodium benzoate, sucrose, talc, titanium dioxide, white wax

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENTS IN ADVIL® COLD & SINUS

Non Drowsy

Ibuprofen Cold & Sinus

Ibuprofen 200 mg – Pain Reliever/Fever Reducer (NSAID)*

Pseudoephedrine HCl 30 mg – Nasal Decongestant

Tablets, USP

*nonsteroidal anti-inflammatory drug

Relieves Sinus Pressure, Nasal Congestion and Fever

See New Warnings Information

**OVAL-SHAPED TABLETS

NDC 68258-8902-02

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	1
1299021	ibuprofen 200 MG / pseudoephedrine hydrochloride 30 MG Oral Tablet	SCD	1

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68258-8902-2	2019-11-27	C162847	48780-1	9855d018-ec60-cd31-e053-dbdaa90ab51a	Amerisource Bergen Ibuprofen Cold and Sinus Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68258-8902-2	Good Neighbor Pharmacy Ibuprofen Cold and Sinus	2 in 1 CARTON	TABLET	2		1
68258-8902-2	Good Neighbor Pharmacy Ibuprofen Cold and Sinus	10 in 1 BLISTER PACK	TABLET	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68258-8902	GOOD NEIGHBOR PHARMACY IBUPROFEN COLD AND SINUS (IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET [DISPENSING SOLUTIONS, INC.]	1	Legacy NDC, 2 package rows	20130606_d60cc253-e77e-422a-aeb5-1565bf048d76.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68258-8902-2	EA - Each	68258-8902	c1383b42-a347-4d2a-ba7f-6778c51af809	1	2013-07-02
24385-465-60	EA - Each	24385-465	6abcb2d6-9749-4b73-8ace-cf9c7f9f603f	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	1
PSEUDOEPHEDRINE HYDROCHLORIDE	ACTIVE INGREDIENT	6V9V2RYJ8N	1
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	1
PSEUDOEPHEDRINE	ACTIVE MOIETY	7CUC9DDI9F	1
ACACIA	INACTIVE INGREDIENT	5C5403N26O	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	1
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	1
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	1

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

Good Neighbor Pharmacy Ibuprofen Cold and Sinus
Ibuprofen, Pseudoephedrine Hydrochloride
IBUPROFEN
PSEUDOEPHEDRINE HYDROCHLORIDE
PSEUDOEPHEDRINE
ACACIA
CALCIUM CARBONATE
CARNAUBA WAX
SUCROSE
STARCH, CORN
CROSCARMELLOSE SODIUM
CROSPOVIDONE
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GUAR GUM
HYDROXYPROPYL CELLULOSE
KAOLIN
POWDERED CELLULOSE
POVIDONE
SILICON DIOXIDE
SODIUM BENZOATE
TALC
TITANIUM DIOXIDE
WHITE WAX
POLYETHYLENE GLYCOLS

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68258-8902	68258-8902-2
24385-465

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 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
SUCROSE	C151H8M554	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
HYDROXYPROPYL CELLULOSE	RFW2ET671P	IACT
KAOLIN	24H4NWX5CO	IACT
POWDERED CELLULOSE	SMD1X3XO9M	IACT
POVIDONE	FZ989GH94E	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WHITE WAX	7G1J5DA97F	IACT
POLYETHYLENE GLYCOLS	3WJQ0SDW1A	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 9 · 529 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ACACIA	ACACIA	5C5403N26O	TABLET, CHEWABLE / ORAL		121 mg	Exact identifier — unii candidate 19 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 candidate 34 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	POWDER / TOPICAL		10056 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, DELAYED RELEASE / ORAL	0.08 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	CAPSULE / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, EXTENDED RELEASE / ORAL		56 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL		750 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET / BUCCAL	1 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	SOLUTION / RECTAL	0.5 %w/v		Exact identifier — unii candidate 34 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	CAPSULE, DELAYED RELEASE PELLETS / ORAL		32 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	SUSPENSION / OPHTHALMIC	0.2 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, COATED / ORAL	49.2 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, DELAYED RELEASE / ORAL	19 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE / ORAL	5000 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, SOLUBLE / ORAL		2 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED PELLETS / ORAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	DROPS / ORAL	NA		Exact identifier — unii candidate 35 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	POWDER, FOR SUSPENSION / ORAL	11.25 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	PASTILLE / ORAL	143 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	POWDER, FOR SUSPENSION / ORAL		34 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET, DELAYED RELEASE / ORAL	30 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SUSPENSION / ORAL		3 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, COATED / ORAL		224 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	WAFER / ORAL	155.2 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
HYDROXYPROPYL CELLULOSE	HYDROXYPROPYL CELLULOSE (1600000 WAMW)	RFW2ET671P	LOZENGE / ORAL		500 mg	Exact identifier — unii candidate 27 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	POWDER, FOR SOLUTION / ORAL	0.33 mg/5ml		Exact identifier — unii candidate 28 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION / INTRAMUSCULAR	16 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET / SUBLINGUAL	9.1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING / ORAL		6 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET / BUCCAL	1.1 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE, DELAYED RELEASE / ORAL		20 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
FD&C YELLOW NO. 6	FD&C YELLOW NO. 6	H77VEI93A8	CONCENTRATE / ORAL	0.03 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
SUCROSE	SUCROSE	C151H8M554	CAPSULE, COATED, EXTENDED RELEASE / ORAL		86 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	LOTION / TOPICAL	NA		Exact identifier — unii candidate 15 equally ranked IID candidates
FD&C RED NO. 40	FD&C RED NO. 40	WZB9127XOA	CAPSULE / ORAL		16 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
CALCIUM CARBONATE	CALCIUM CARBONATE	H0G9379FGK	CAPSULE / ORAL	349.9 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
CROSCARMELLOSE SODIUM	CROSCARMELLOSE SODIUM	M28OL1HH48	TABLET, CHEWABLE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
POWDERED CELLULOSE	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, COATED / ORAL	40.2 mg		Exact identifier — unii candidate 16 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	SYSTEM / TOPICAL		420 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM / VAGINAL		40 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, COATED / ORAL	42.12 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, ORALLY DISINTEGRATING / ORAL		68 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	POWDER, FOR SUSPENSION / ORAL		7386 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ACACIA	ACACIA	5C5403N26O	TABLET / BUCCAL	9.1 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM BENZOATE	SODIUM BENZOATE	OJ245FE5EU	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 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
TALC	TALC	7SEV7J4R1U	LOZENGE / ORAL		50 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	SUSPENSION/ DROPS / OPHTHALMIC	0.6 %w/v		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 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
1876c780-20ee-4f51-91a1-f7ae376a2dda			d60cc253-e77e-422a-aeb5-1565bf048d76	2013-06-05	Warnings	Exact identifier spl id: 1876c780-20ee-4f51-91a1-f7ae376a2dda spl set id: d60cc253-e77e-422a-aeb5-1565bf048d76

Reported adverse events (FAERS/openFDA)#

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