Advil Ibuprofen Tablets, 200mg Pain Reliever/Fever Reducer(NSAID)

Manufacturer: R J General Corporation
Effective date: 2025-11-17
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 01:16:31

Label at a glance#

ProductIbuprofen 200 mg

Active ingredientIBUPROFEN

Label structure8 sections

Indications and uses

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

Contacts and useful links#

PhoneLabel contact1-800-88-ADVIL

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)	Purpose
Ibuprofen 200 mg (NSAID) ^*	Pain reliever/Fever reducer

* nonsteroidal anti-inflammatory drug

Uses

INDICATIONS & USAGE SECTION

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

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:

WARNINGS AND PRECAUTIONS 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

SPL UNCLASSIFIED SECTION

Heart attack and stroke warming:NSAIDs, except aspirin, increase the risk of 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 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, 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

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

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 problem 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

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 at 20 weeks or later in 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
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

SPL UNCLASSIFIED SECTION

read all warnings and directions before use. Keep Carton.
store at 20-25°C (68-77°F)
avoid excessive heat above 40°C (104°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acetylated monoglycerides, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, synthetic iron oxide, titanium dioxide, white wax

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-88-ADVIL

Distributed by:

GSK CH, Warren,

NJ 07059

Packaged and distributed by RJ Corp with the permission of HALEON.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ibuprofen 200 mg - NDC 70264-042-01 - Carton Label

image description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310965	ibuprofen 200 MG Oral Tablet	PSN	2
310965	ibuprofen 200 MG Oral Tablet	SCD	2
310965	ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral Tablet	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
IBUPROFEN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20191108

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70264-042-01	Ibuprofen 200 mg	50 in 1 CARTON	TABLET, COATED	50		2
70264-042-01	Ibuprofen 200 mg	2 in 1 POUCH	TABLET, COATED	2		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0573-0150-20	EA - Each	0573-0150	c82bce07-e8b2-4c67-8699-20f87feeb2c7	1	2012-07-24
0573-0150-30	EA - Each	0573-0150	fdac2299-90ca-4a08-8274-ff14b6780145	1	2012-07-24
0573-0150-40	EA - Each	0573-0150	3081fb42-6664-4245-b057-c82112c71668	1	2012-07-24

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

Ibuprofen 200 mg
Ibuprofen
DIACETYLATED MONOGLYCERIDES
SILICON DIOXIDE
STARCH, CORN
CROSCARMELLOSE SODIUM
METHYLPARABEN
MICROCRYSTALLINE CELLULOSE
SHELLAC
ALCOHOL
POVIDONE
PROPYLPARABEN
SODIUM BENZOATE
SODIUM LAURYL SULFATE
STEARIC ACID
SUCROSE
FERRIC OXIDE RED
TITANIUM DIOXIDE
WHITE WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70264-042	70264-042-01
0573-0150

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DIACETYLATED MONOGLYCERIDES	5Z17386USF	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
STARCH, CORN	O8232NY3SJ	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
SHELLAC	46N107B71O	IACT
ALCOHOL	3K9958V90M	IACT
POVIDONE	FZ989GH94E	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
STEARIC ACID	4ELV7Z65AP	IACT
SUCROSE	C151H8M554	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WHITE WAX	7G1J5DA97F	IACT
IBUPROFEN	WK2XYI10QM	ACTIB

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
N018989-001	ADVIL	IBUPROFEN	200MG	TABLET / ORAL		RLD, RS	1984-05-18

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018989-001	ADVIL	200MG	TABLET / ORAL		1984-05-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018989-001	ADVIL	200MG	TABLET / ORAL	RLD, RS	1984-05-18	`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
ADVIL	IBUPROFEN	Haleon US Holdings LLC	1a665e64-9f30-be37-4a83-38789f1f1e89	2026-03-12	Warnings	Exact identifier ndc (product): 0573-0150
Ibuprofen 200 mg	IBUPROFEN	R J General Corporation	cd3060a5-3b90-42e4-89cd-3b620859045f	2025-11-17	Warnings	Exact identifier ndc (package): 70264-042-01 ndc (product): 70264-042 ndc11 (package): 70264004201 spl id: 43c90d03-e359-6ce4-e063-6394a90a1da2 spl set id: cd3060a5-3b90-42e4-89cd-3b620859045f

Reported adverse events (FAERS/openFDA)#

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