Label: ADVIL- ibuprofen tablet, coated
- NDC Code(s): 50269-157-01, 50269-157-02, 50269-157-03
- Packager: JC World Bell Wholesale Co., Inc.
- This is a repackaged label.
- Source NDC Code(s): 0573-0154
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated June 30, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet)
- Uses
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Warnings
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
• 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
• 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
• under a doctor’s care for any serious condition • taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspiritin • taking any other drug
Stop use and aIf pregnant or breast-feeding,sk a doctor if
• 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
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Directions
• 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
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Inactive ingredients
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?
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INGREDIENTS AND APPEARANCE
ADVIL
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50269-157(NDC:0573-0154) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 200 mg Inactive Ingredients Ingredient Name Strength DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) METHYLPARABEN (UNII: A2I8C7HI9T) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SHELLAC (UNII: 46N107B71O) POVIDONE (UNII: FZ989GH94E) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM LAURYL SULFATE (UNII: 368GB5141J) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WHITE WAX (UNII: 7G1J5DA97F) Product Characteristics Color brown Score no score Shape ROUND Size 11mm Flavor Imprint Code Advil Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50269-157-01 6 in 1 BOX 05/18/1984 1 1 in 1 BLISTER PACK 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:50269-157-02 6 in 1 BOX 05/18/1984 2 2 in 1 BLISTER PACK 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:50269-157-03 25 in 1 BOX 05/18/1984 3 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018989 05/18/1984 Labeler - JC World Bell Wholesale Co., Inc. (805257581)
