Ibuprofen

Manufacturer: AAA Pharmaceutical, Inc.
Effective date: 2019-09-11
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 00:12:29

Label at a glance#

ProductIbuprofen

Active ingredientIBUPROFEN

Label structure9 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache muscular aches minor pain of arthritis toothache 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 do not take longer than 10 days, unless directed by a doctor (see Warnings ) adults and children 12 years and over take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years ask a doctor

Storage and handling

store between 20º-25ºC (68º-77ºF) avoid excessive heat above 40°C (104°F) read all warnings and directions before use retain carton for complete product information

Contacts and useful links#

PhoneFDA MedWatch1-800-FDA-1088

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen, USP 200 mg (NSAID ¹)

1 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
- minor pain of arthritis
- toothache
- backache
- the common cold
- menstrual cramps
temporarily reduces fever

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

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to any other pain reliever/fever reducer
right before or after heart surgery

OTC - ASK DOCTOR SECTION

Ask a doctor before use if

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, or asthma
you are taking a diuretic

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

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

OTC - WHEN USING SECTION

When using this product

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
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
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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

do not take more than directed
the smallest effective dose should be used
do not take longer than 10 days, unless directed by a doctor (see Warnings)

adults and children 12 years and over	take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor
children under 12 years	ask a doctor

Other information

STORAGE AND HANDLING SECTION

store between 20º-25ºC (68º-77ºF)
avoid excessive heat above 40°C (104°F)
read all warnings and directions before use
retain carton for complete product information

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, corn starch, hypromellose, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone K30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RESTORE u

NDC 57344-111-03

†COMPARE TO THE ACTIVE INGREDIENT IN MOTRIN IB®

Ibuprofen
Tablets, 200 mg

Pain Reliever, Fever Reducer

(NSAID)

100 COATED TABLETS

image description

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Ibuprofen	ACTIVE INGREDIENT	WK2XYI10QM	1
Ibuprofen	ACTIVE MOIETY	WK2XYI10QM	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	1
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	1
povidone K30	INACTIVE INGREDIENT	U725QWY32X	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
sodium starch glycolate type A corn	INACTIVE INGREDIENT	AG9B65PV6B	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Ibuprofen
SILICON DIOXIDE
STARCH, CORN
HYPROMELLOSE, UNSPECIFIED
FD&C YELLOW NO. 6
ALUMINUM OXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYDEXTROSE
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
TALC
TITANIUM DIOXIDE
TRIACETIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57344-111	57344-111-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
FD&C YELLOW NO. 6	H77VEI93A8	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POLYDEXTROSE	VH2XOU12IE	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POVIDONE, UNSPECIFIED	FZ989GH94E	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
TRIACETIN	XHX3C3X673	IACT
IBUPROFEN	WK2XYI10QM	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 · 359 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	POWDER, FOR SOLUTION / ORAL		690 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET / BUCCAL		18 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE / ORAL		55 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
povidone K30	POVIDONE K30	U725QWY32X	GRANULE, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	FILM / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FOR SUSPENSION / ORAL		220 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL		80 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
povidone K30	POVIDONE K30	U725QWY32X	CAPSULE, COATED, EXTENDED RELEASE / ORAL		15 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / VAGINAL	8 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
povidone K30	POVIDONE K30	U725QWY32X	POWDER, FOR SUSPENSION / ORAL		257 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED PELLETS / ORAL	3.32 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		357 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE / ORAL		300 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IMPLANT / INTRAVITREAL	1.66 mg		Exact identifier — unii candidate 28 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET / SUBLINGUAL		409 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	CAPSULE / ORAL		729 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	JELLY / TOPICAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
povidone K30	POVIDONE K30	U725QWY32X	FILM, EXTENDED RELEASE / TRANSDERMAL		16 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, LIQUID FILLED / ORAL		12 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 27 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	TABLET, CHEWABLE / ORAL	0.41 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	INSERT / VAGINAL		147 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	SUSPENSION, EXTENDED RELEASE / ORAL		46 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	INSERT / VAGINAL	54.21 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SYSTEM / TRANSDERMAL		35 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, DELAYED RELEASE / ORAL		80 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / SUBLINGUAL		10 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, DELAYED RELEASE PELLETS / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
talc	TALC	7SEV7J4R1U	OINTMENT / TOPICAL	74.6 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / BUCCAL		3 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, CHEWABLE / ORAL	11.8 mg		Exact identifier — unii candidate 27 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 28 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
talc	TALC	7SEV7J4R1U	TABLET / ORAL	1000 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	DROPS / ORAL	NA		Exact identifier — unii candidate 49 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	CAPSULE, DELAYED RELEASE / ORAL		366 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	SYRUP / ORAL	4 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER, FOR SUSPENSION / ORAL		6 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
triacetin	TRIACETIN	XHX3C3X673	TABLET, FILM COATED / ORAL	15.12 mg		Exact identifier — unii candidate 14 equally ranked IID candidates
povidone K30	POVIDONE K30	U725QWY32X	PELLET / ORAL		24 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
cellulose, microcrystalline	MICROCRYSTALLINE CELLULOSE	OP1R32D61U	TABLET, FILM COATED / ORAL		992 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	GEL / DENTAL	19 %w/w		Exact identifier — unii candidate 49 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
A091355-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2011-04-04

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	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091355-001	IBUPROFEN	200MG	TABLET / ORAL	2011-04-04	`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
d010efeb-5f97-3620-e053-2995a90ad8ff			0ae0b0b2-5c0e-45e3-9ec1-b92e6f3eff1d	2021-11-05	Warnings	Exact identifier spl set id: 0ae0b0b2-5c0e-45e3-9ec1-b92e6f3eff1d

Reported adverse events (FAERS/openFDA)#

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