![JUNIOR STRENGTH ADVIL (IBUPROFEN) TABLET, COATED [WYETH CONSUMER HEALTHCARE LLC]](https://medic.hrt.org//dailymed/images/5ed0d404-c54d-b05f-578a-d2730e8a78ee/advil-02.jpg)
| NDC | 0573-0175-11 |
| Set ID | 5ed0d404-c54d-b05f-578a-d2730e8a78ee |
| Category | HUMAN OTC DRUG LABEL |
| Packager | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | NDA020267 |
- 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 the child
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- has had stomach ulcers or bleeding problems
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- takes a blood thinning (anticoagulant) or steroid drug
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- takes other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
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- takes 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.
Sore throat warning:
Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult doctor promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by doctor.
Do not use
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- if the child has 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 the child
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- child has problems or serious side effects from taking pain relievers or fever reducers
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- child has a history of stomach problems, such as heartburn
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- child has high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
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- child has not been drinking fluids
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- child has lost a lot of fluid due to vomiting or diarrhea
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- child is taking a diuretic
Ask a doctor or pharmacist before use if the child is
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- under a doctor's care for any serious condition
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- taking any other drug
Stop use and ask a doctor if
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- child experiences any of the following signs of stomach bleeding:
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- feels faint
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- vomits blood
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- has bloody or black stools
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- has stomach pain that does not get better
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- child has 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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- child does not get any relief within first day (24 hours) of treatment
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- fever or pain 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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- this product does not contain directions or complete warnings for adult use
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- do not give more than directed
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- find right dose on chart below. If possible, use weight to dose; otherwise use age.
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- repeat dose every 6-8 hours, if needed
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- do not use more than 4 times a day
Dosing Chart Weight (lb) Age (yr) Dose (tablets) under 48 lb
under 6 yr
ask a doctor
48-71 lb
6-10 yr
2 tablets
72-95 lb
11 yr
3 tablets
- OTHER INFORMATION
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INACTIVE INGREDIENTS
acetylated monoglycerides, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, methylparaben, microcrystalline cellulose, pharmaceutical glaze, pharmaceutical ink, povidone, pregelatinized starch, propylparaben, sodium benzoate, stearic acid, sucrose, synthetic iron oxides, titanium dioxide
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JUNIOR STRENGTH ADVIL
ibuprofen tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0573-0175 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 100 mg Inactive Ingredients Ingredient Name Strength DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF) CARNAUBA WAX (UNII: R12CBM0EIZ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) METHYLPARABEN (UNII: A2I8C7HI9T) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SHELLAC (UNII: 46N107B71O) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM BENZOATE (UNII: OJ245FE5EU) STEARIC ACID (UNII: 4ELV7Z65AP) SUCROSE (UNII: C151H8M554) FERRIC OXIDE RED (UNII: 1K09F3G675) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color BROWN (tan) Score no score Shape ROUND (round tablet) Size 8mm Flavor Imprint Code Advil;100 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0573-0175-11 1 in 1 CARTON 06/21/2011 1 24 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 NDA020267 06/21/2011 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) Establishment Name Address ID/FEI Business Operations Wyeth Pharmaceuticals Company 829390975 ANALYSIS(0573-0175) , LABEL(0573-0175) , MANUFACTURE(0573-0175) , PACK(0573-0175)
