Drug Facts

Manufacturer: Haleon US Holdings LLC | PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC
Effective date: 2026-08-20
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: daily-update
Hydrated at: 2026-08-22 01:01:11

Label at a glance#

ProductAdvil Menstrual Pain

Active ingredientIBUPROFEN SODIUM

Label structure10 sections

Indications and uses

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

Storage and handling

each tablet contains: sodium 22 mg 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)

Contacts and useful links#

PhoneLabel contact1-800-88-ADVIL

Websitewww.advil.com

www.Advil.com

Websitewww.productpats.com

www.productpats.com

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Ibuprofen 200 mg (provided as ibuprofen sodium 256 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:
- menstrual cramps
- backache
- headache
- muscular aches
- the common cold
- toothache
- minor pain of arthritis
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

Heart attack and stroke warning:

SPL UNCLASSIFIED SECTION

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 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 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

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

STORAGE AND HANDLING SECTION

each tablet contains: sodium 22 mg
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

acesulfame potassium, caramel color, carnauba wax, colloidal silicon dioxide, copovidone, ferric oxide, hypromellose, mannitol, medium-chain triglycerides, microcrystalline cellulose, natural and artificial flavor, pharmaceutical ink, polyethylene glycol, propylene glycol, sodium lauryl sulfate, sucralose, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call weekdays 9 AM to 5 PM EST at 1-800-88-ADVIL

Additional Information

SPL UNCLASSIFIED SECTION

Do Not Use if seal under bottle cap imprinted with

“SEALED for YOUR PROTECTION” is broken or missing.

READ AND KEEP CARTON FOR COMPLETE

WARNINGS AND INFORMATION

For most recent product information, visit www.Advil.com

Trademarks owned or licensed by GSK Patents: www.productpats.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0573-0230-20

Advil

menstrual
PAIN

FILM-COATED
IBUPROFEN
SODIUM

Ibuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)

Advil Tablets

20 Tablets

000068432 Front Carton

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0573-0230-20	2024-01-31	C162847	48780-1	1030e365-4a7f-111a-e063-dadaa90a10e2	Drug Facts
0573-0230-20	2024-01-31	C162847	48780-1	1030e365-4a7f-111a-e063-dadaa90a10e2	Drug Facts
0573-0230-40	2024-01-31	C162847	48780-1	1030e365-4a7f-111a-e063-dadaa90a10e2	Drug Facts
0573-0230-40	2024-01-31	C162847	48780-1	1030e365-4a7f-111a-e063-dadaa90a10e2	Drug Facts

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

Advil Menstrual Pain
ibuprofen sodium
IBUPROFEN
ACESULFAME POTASSIUM
CARNAUBA WAX
SILICON DIOXIDE
COPOVIDONE K25-31
FERRIC OXIDE RED
HYPROMELLOSE, UNSPECIFIED
MANNITOL
MEDIUM-CHAIN TRIGLYCERIDES
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL, UNSPECIFIED
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
SUCRALOSE
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0573-0230	0573-0230-20, 0573-0230-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
IBUPROFEN SODIUM	RM1CE97Z4N	ACTIB
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
COPOVIDONE K25-31	D9C330MD8B	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
MANNITOL	3OWL53L36A	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SUCRALOSE	96K6UQ3ZD4	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
6	2024-01-31	full-release	2026-06-01 00:08:10

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
N201803-001	ADVIL	IBUPROFEN SODIUM	EQ 200MG BASE	TABLET / ORAL		RLD, RS	2012-06-12

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	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201803-001	ADVIL	EQ 200MG BASE	TABLET / ORAL	RLD, RS	2012-06-12	`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
Advil Menstrual Pain	IBUPROFEN SODIUM	Haleon US Holdings LLC	ae1625f4-ef32-4d4f-bf54-c44085843e41	2026-08-20	Warnings	Exact identifier ndc (package): 0573-0230-40 ndc (package): 0573-0230-20 ndc (product): 0573-0230 ndc11 (package): 00573023040 ndc11 (package): 00573023020 spl id: 597d1b09-7a67-67b9-e063-6394a90aa0bd spl set id: ae1625f4-ef32-4d4f-bf54-c44085843e41

Reported adverse events (FAERS/openFDA)#

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