Label: ADVIL MENSTRUAL PAIN- ibuprofen sodium tablet, coated
- NDC Code(s): 0573-0230-20, 0573-0230-40
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 31, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Allergy alert:
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
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- hives
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- facial swelling
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- asthma (wheezing)
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- shock
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- skin reddening
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- rash
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- 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:
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- are age 60 or older
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- have had stomach ulcers or bleeding problems
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- take a blood thinning (anticoagulant) or steroid drug
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- take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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- have 3 or more alcoholic drinks every day while using this product
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- 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
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- if you have ever had an allergic reaction to any other pain reliever/fever reducer
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- right before or after heart surgery
Ask a doctor before use if
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- stomach bleeding warning applies to you
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- you have problems or serious side effects from taking pain relievers or fever reducers
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- you have a history of stomach problems, such as heartburn
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- you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
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- you are taking a diuretic
Ask a doctor or pharmacist before use if you are
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- under a doctor's care for any serious condition
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- taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
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- taking any other drug
Stop use and ask a doctor if
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- you experience any of the following signs of stomach bleeding:
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- feel faint
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- vomit blood
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- have bloody or black stools
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- have stomach pain that does not get better
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- you have symptoms of heart problems or stroke:
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- chest pain
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- trouble breathing
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- weakness in one part or side of body
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- slurred speech
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- leg swelling
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- pain gets worse or lasts more than 10 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present in the painful area
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- any new symptoms appear
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Directions
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- do not take more than directed
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- the smallest effective dose should be used
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- adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist
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- if pain or fever does not respond to 1 tablet, 2 tablets may be used
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- do not exceed 6 tablets in 24 hours, unless directed by a doctor
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- children under 12 years: ask a doctor
- Other information
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Inactive ingredients
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?
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Additional Information
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
Dist. by: GSK CH, Warren, NJ 07059 ©2021 GSK or licensor
Trademarks owned or licensed by GSK Patents: www.productpats.com
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ADVIL MENSTRUAL PAIN
ibuprofen sodium tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0230 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN SODIUM (UNII: RM1CE97Z4N) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN SODIUM 256 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) COPOVIDONE K25-31 (UNII: D9C330MD8B) FERRIC OXIDE RED (UNII: 1K09F3G675) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MANNITOL (UNII: 3OWL53L36A) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SUCRALOSE (UNII: 96K6UQ3ZD4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BROWN (beige) Score no score Shape ROUND Size 10mm Flavor Imprint Code Advil;msp Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0230-20 1 in 1 CARTON 07/01/2016 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0573-0230-40 1 in 1 CARTON 07/01/2016 2 40 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA201803 06/30/2016 Labeler - Haleon US Holdings LLC (079944263) Establishment Name Address ID/FEI Business Operations PF Consumer Healthcare B.V. (Puerto Rico Operations) LLC 118346012 ANALYSIS(0573-0230) , LABEL(0573-0230) , MANUFACTURE(0573-0230) , PACK(0573-0230)
