Label: ADVIL MIGRAINE- ibuprofen capsule, liquid filled
- NDC Code(s): 0573-0168-20, 0573-0168-30, 0573-0168-40
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 1, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each brown oval capsule)
- Purpose
- Use
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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.
Medication overuse headache warning:
Headaches may worsen if this product is used for 10 or more days per month.
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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- you have never had migraines diagnosed by a health professional
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- you have a headache that is different from your usual migraines
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- you have the worst headache of your life
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- you have fever and stiff neck
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- you have headaches beginning after or caused by head injury, exertion, coughing or bending
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- you have experienced your first headache after the age of 50
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- you have daily headaches
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- you have a migraine so severe as to require bed rest
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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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- migraine headache pain is not relieved or gets worse after the first dose
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- any new symptoms appear
- Directions
- Other information
- Inactive ingredients
- Questions or Comments?
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Additional Information
READ AND KEEP CARTON FOR COMPLETE
WARNINGS AND INFORMATIONDo Not Use if seal under bottle cap imprinted with “SEALED for YOUR PROTECTION” is broken or missing.
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ADVIL MIGRAINE
ibuprofen capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0168 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) LIGHT MINERAL OIL (UNII: N6K5787QVP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color BROWN (translucent brown) Score no score Shape OVAL (soft gelatin capsule) Size 17mm Flavor Imprint Code Advil Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0168-20 1 in 1 CARTON 03/16/2000 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0573-0168-30 1 in 1 CARTON 03/16/2000 2 40 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0573-0168-40 1 in 1 CARTON 03/16/2000 3 80 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 NDA020402 03/16/2000 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)