674 Ibuprofen Tablets USP

Manufacturer: Medline industries, LP
Effective date: 2026-06-04
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: daily-update
Hydrated at: 2026-06-11 05:10:28

Label at a glance#

ProductIbuprofen

Active ingredientIBUPROFEN

Label structure11 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 adults and children 12 years and older 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 at 20°-25°C (68° to 77°F). [See USP Controlled Room Temperature]. Avoid excessive heat above 40°C (104°F).

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-770-3183

Websitewww.medline.com

www.medline.com

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen UPS, 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
- minor pain of arthritis
- toothache
- 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
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

Heart attack and stroke warning: 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

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

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have problems or serious side effects from taking pain relievers or fever reducers
the stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke
you are taking a diuretic

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
under a doctor’s care for any serious condition
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
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 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 (1-800-222-1222) right away.

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 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 at 20°-25°C (68° to 77°F). [See USP Controlled Room Temperature].
Avoid excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, iron oxide red, maize starch, polyethylene glycol, povidone k-30, pregelatinized starch, sodium starch glycolate, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-770-3183 weekdays 9:00 AM to 4:30 PM EST

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in India

www.medline.com

1-800-MEDLINE (633-5463)

REF: OTCM00020

V1 RE22GAE

RECENT MAJOR CHANGES SECTION

Dosage and Administration

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label V1 RE22GAE

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	Code 128	(01)10193489141740	GTIN-14: 10193489141740 GTIN storage (14 digits): 10193489141740	53329-674_V1 RE22GAE.jpg

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
557673c2-8256-b351-e863-4ec71a5a64b0	Product name	2	20160714
dbc9a339-6215-4e94-9546-57a3b34902ce	Product name	1	20160517
61c18d4e-b552-5478-8fc0-df38b93e3100	Product name	1	20140508
7b2938c9-7eb7-e312-ae90-f54f4240361e	Product name	1	20140508
997601aa-bb5f-6971-6b90-a21132c12c7b	Product name	1	20140508

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
IBUPROFEN	ACTIVE INGREDIENT	WK2XYI10QM	2
IBUPROFEN	ACTIVE MOIETY	WK2XYI10QM	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	2
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	2
SODIUM STARCH GLYCOLATE TYPE A CORN	INACTIVE INGREDIENT	AG9B65PV6B	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	2
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	2

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Ibuprofen
SILICON DIOXIDE
STARCH, CORN
FERRIC OXIDE RED
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
TITANIUM DIOXIDE
TALC
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53329-674	53329-674-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
POVIDONE K30	U725QWY32X	IACT
SODIUM STARCH GLYCOLATE TYPE A CORN	AG9B65PV6B	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
IBUPROFEN	WK2XYI10QM	ACTIB
TALC	7SEV7J4R1U	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
8	2023-08-09	full-release	2026-05-31 23:55:51

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 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / ORAL	8 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET / ORAL	2828 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
LACTOSE MONOHYDRATE	LACTOSE MONOHYDRATE	EWQ57Q8I5X	TABLET / ORAL	4384 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET / ORAL	8 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET / ORAL	208 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET / ORAL	1127 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
POVIDONE K30	POVIDONE K30	U725QWY32X	TABLET / ORAL	2828 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TRIACETIN	TRIACETIN	XHX3C3X673	TABLET / ORAL	208 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET / ORAL	232 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL	1116 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
STEARIC ACID	STEARIC ACID	4ELV7Z65AP	TABLET / ORAL	336 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET / ORAL	750 mg	Exact identifier — unii+route+dosage form 2 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
A079174-001	IBUPROFEN	IBUPROFEN	200MG	TABLET / ORAL			2010-12-10

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	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079174-001	IBUPROFEN	200MG	TABLET / ORAL	2010-12-10	`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
Ibuprofen	IBUPROFEN	Medline industries, LP	5d2482b4-cd90-4246-85a9-fd1d35315b6c	2026-06-04	Warnings	Exact identifier ndc (package): 53329-674-30 ndc (product): 53329-674 ndc11 (package): 53329067430 spl id: 536feefb-4af9-5c62-e063-6294a90a3c95 spl set id: 5d2482b4-cd90-4246-85a9-fd1d35315b6c

Reported adverse events (FAERS/openFDA)#

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