Ibuprofen

Manufacturer: ASSURED / DOLLAR TREE (Greenbrier International, Inc.)
Effective date: 2019-07-10
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:19:03

Label at a glance#

ProductIbuprofen

Active ingredientIBUPROFEN

Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache muscular aches toothache minor pain of arthritis backache the common cold menstrual cramps temporarily reduces fever

Dosage and administration

do not take more than directed the smallest effective dose should be used adults and children 12 years and older: take 1 caplet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 caplet, 2 caplets may be used do not exceed 6 caplets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-753-3935

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen USP, 200 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain Reliever/ fever Reducer

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- toothache
- minor pain of arthritis
- backache
- the common cold
- menstrual cramps
- temporarily reduces fever

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
rash
blisters
skin reddening

If an allergic reaction occurs, stop use an 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 oder
have had stomach ulders or bleeding problems
take blood thinning (anticoagulant) or steroid drug
take other drugs containing prescritpion or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
take more or for a longer time than directed
have 3 or more alcoholic drinks everyday while using this prdouct

Do not use

OTC - DO NOT USE SECTION

if you ever had an allergic reaction to any other pain reliever/fever reducer
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, or kidney disease
you have asthma
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 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
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
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
redness or swelling is present in the painful area
any new symptoms appear

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 druing the last 3 months of pegnancy unless defintely 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 and older:
- take 1 caplet every 4 to 6 hours while symptoms persist
- if pain or fever does not respond to 1 caplet, 2 caplets may be used
- do not exceed 6 caplets in 24 hours, unless directed by a doctor
children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

store between 20- 25^o C (68^o- 77^o F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, croscarmellose sodium, hypromellose, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch, red iron oxide, silicon dioxide, stearic acid, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENT OF ADVIL® TABLETS†

Ibuprofen

Ibuprofen Tablets USP, 200 mg

Pain reliever / Fever reducer (NSAID)

Tablets

†This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Advil® Tablets.

DO NOT USE IF TAMPER-EVIDENT SEAL UNDER BOTTLE CAP PRINTED WITH "SEALED FOR YOUR PROTECTION" IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC,

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Ibuprofen
CARNAUBA WAX
CROSCARMELLOSE SODIUM
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
FERRIC OXIDE RED
SILICON DIOXIDE
STEARIC ACID
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
33992-0209	33992-0209-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN	WK2XYI10QM	ACTIB
CARNAUBA WAX	R12CBM0EIZ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
STARCH, CORN	O8232NY3SJ	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

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
A076460-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2003-11-26

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	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076460-001	IBUPROFEN	200MG	TABLET / ORAL	2003-11-26	`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
c54bffae-0f39-4916-ab94-f77efb4f799e			3b9cc121-7aa2-483e-bcbf-6cc4b80b68f8	2019-07-10	Warnings	Exact identifier spl id: c54bffae-0f39-4916-ab94-f77efb4f799e spl set id: 3b9cc121-7aa2-483e-bcbf-6cc4b80b68f8

Reported adverse events (FAERS/openFDA)#

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