- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS AND 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:
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■ hives ■ facial swelling
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■ asthma (wheezing) ■ shock
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■ skin reddening ■ rash ■ blisters
If an allergic reaction occurs, stop use and seek medical help right away.
Stomach bleeding warning:
This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chances are higher if your 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 an NSAID (aspirin, ibuprofen, naproxen, or others)
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■ takes more or for a longer time 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.
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- OTC - DO NOT USE
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OTC - ASK DOCTOR
Ask a doctor before use if:
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■ child has problems or serious side effects from taking pain relievers or fever reducers
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■ stomach bleeding warning applies to your child
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■ child has a history of stomach problems, such as heartburn
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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 has high blood pressure, heart disease, liver cirrhosis, or kidney disease
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■ child has asthma
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■ child is taking a diuretic
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- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
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OTC - STOP USE
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 ■ vomits blood ■ has bloody or black stools
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■ has stomach pain that does not get better
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■ the child does not get any relief within the 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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- OTC - KEEP OUT OF REACH OF CHILDREN
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DOSAGE AND ADMINISTRATION
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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■ shake well before using
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■ find right dose on chart below (if possible, use weight to dose; otherwise use age)
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■ use only enclosed measuring cup
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■ if needed, repeat dose every 6-8 hours
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■ do not use more than 4 times a day
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■ replace original bottle cap to maintain child resistance
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- OTHER INFORMATION
- INACTIVE INGREDIENTS
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
IBUPROFEN PAIN RELIEVER/ FEVER REDUCER
ibuprofen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65162-672 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color ORANGE Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65162-672-86 1 in 1 CARTON 1 118 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA200457 11/12/2011 Labeler - Amneal Pharmaceuticals (123797875) Registrant - Amneal Pharmaceuticals (123797875) Establishment Name Address ID/FEI Business Operations Amneal Pharmaceuticals 968119730 ANALYSIS, MANUFACTURE, LABEL, PACK