Label: ADVIL- ibuprofen sodium tablet, coated
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NDC Code(s):
0573-0133-01,
0573-0133-02,
0573-0133-04,
0573-0133-05, view more0573-0133-20, 0573-0133-40, 0573-0133-41, 0573-0133-80, 0573-0133-81, 0573-0133-88, 0573-0133-89, 0573-0133-91, 0573-0134-20, 0573-0134-80
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 24, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
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 aspirin
- taking any other drug
Stop use and ask 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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DOSAGE & ADMINISTRATION
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
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
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
- Additional Information
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PRINCIPAL DISPLAY PANEL
Advil
FILM-COATED
IBUPROFEN
SODIUMIbuprofen Tablets, 200 mg
(Provided as Ibuprofen Sodium 256 mg)
Pain Reliever / Fever Reducer (NSAID)Advil Tablets
- Headache
- Muscular Aches
- Minor Pain of Arthritis
- Menstrual Cramps
- Toothache
- Fever
See Full Drug Facts information on the back of this dispenser
100 TABLETS
(50 PACKETS of 2 TABLETS EACH)
000068427 Front Carton
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ADVIL
ibuprofen sodium tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0133 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) CARAMEL (UNII: T9D99G2B1R) 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;asymmetrical;underline Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0133-20 1 in 1 CARTON 07/08/2013 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0573-0133-40 1 in 1 CARTON 07/08/2013 2 40 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:0573-0133-80 1 in 1 CARTON 07/08/2013 3 80 in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:0573-0133-02 50 in 1 TRAY 07/08/2013 4 2 in 1 PACKET; Type 0: Not a Combination Product 5 NDC:0573-0133-04 2 in 1 BLISTER PACK 07/08/2013 5 2 in 1 PACKET; Type 0: Not a Combination Product 6 NDC:0573-0133-89 1 in 1 CARTON 07/08/2013 6 160 in 1 BOTTLE; Type 0: Not a Combination Product 7 NDC:0573-0133-81 1 in 1 CARTON 07/08/2013 7 100 in 1 BOTTLE; Type 0: Not a Combination Product 8 NDC:0573-0133-05 2 in 1 CARTON 07/08/2013 8 2 in 1 PACKET; Type 0: Not a Combination Product 9 NDC:0573-0133-88 2 in 1 PACKAGE 07/08/2013 9 120 in 1 BOTTLE; Type 0: Not a Combination Product 10 NDC:0573-0133-41 1 in 1 CARTON 08/12/2015 10 40 in 1 BOTTLE; Type 0: Not a Combination Product 11 NDC:0573-0133-91 1 in 1 CARTON 12/01/2014 11 180 in 1 BOTTLE; Type 0: Not a Combination Product 12 NDC:0573-0133-01 3000 in 1 CASE 08/11/2014 12 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA201803 07/08/2013 ADVIL
ibuprofen sodium tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0134 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) CARAMEL (UNII: T9D99G2B1R) 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 OVAL Size 15mm Flavor Imprint Code Advil;asymmetrical;underline Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0134-20 1 in 1 CARTON 07/08/2013 1 20 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0573-0134-80 1 in 1 CARTON 07/08/2013 2 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 NDA201803 07/08/2013 Labeler - Haleon US Holdings LLC (079944263)