Leader Childrens Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN ANHYDROUS CITRIC ACID BUTYLPARABEN D&C RED NO. 33 FD&C RED NO. 40 FD&C YELLOW NO. 6 GLYCERIN HYPROMELLOSES POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL CORN SYRUP XANTHAN GUM opaque
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel For Ages 2 - 11 Children’s Ibuprofen Oral Suspension 100 mg per 5 mL (teaspoonful) Pain Reliever Fever Reducer (NSAID) Lasts up to 8 Hours Fruit Flavor Alcohol Free Children's Ibuprofen Oral Suspension Carton Children's Ibuprofen Oral Suspension Carton
- Principal Display Panel For Ages 2 - 11 Children’s Ibuprofen Oral Suspension 100 mg per 5 mL (teaspoonful) Pain Reliever Fever Reducer (NSAID) Lasts up to 8 Hours Fruit Flavor Alcohol Free Children's Ibuprofen Oral Suspension Carton Children's Ibuprofen Oral Suspension Carton
Overview
Uses temporarily: • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache • reduces fever
Indications & Usage
Uses temporarily: • relieves minor aches and pains due to the common cold, flu, sore throat, headache and toothache • reduces fever
Dosage & Administration
Directions • this product does not contain directions or complete warnings for adult use • do not give more than directed • do not give longer than 10 days, unless directed by a doctor (see Warnings) • shake well before using • find right dose on chart below. If possible, use weight to dose; otherwise use age. • use only with enclosed measuring cup • if needed, repeat dose every 6-8 hours • do not use more than 4 times a day • replace original bottle cap to maintain child resistance • wash dosage cup after each use Dosing Chart Weight (lb) Age(yrs) Dose (teaspoonful or mL) under 2 years ask a doctor 24-35 lbs 2-3 years 1 tsp or 5 mL 36-47 lbs 4-5 years 1 ½ tsp or 7.5 mL 48-59 lbs 6-8 years 2 tsp or 10 mL 60-71 lbs 9-10 years 2 ½ tsp or 12.5 mL 72-95 lbs 11 years 3 tsp or 15 mL
Warnings & Precautions
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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if the child: • has had stomach ulcers or bleeding problems • takes a blood thinning (anticoagulant) or steroid drug • takes other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others) • 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. Do not use • if the child has ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery Ask a doctor before use if the child has • problems or serious side effects from taking pain relievers or fever reducers • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain • ulcers • bleeding problems • not been drinking fluids • lost a lot of fluid due to vomiting or diarrhea • high blood pressure • heart or kidney disease • taken a diuretic Ask a doctor or pharmacist before use if the child is • taking any other drug containing an NSAID (prescription or nonprescription) • taking a blood thinning (anticoagulant) or steroid drug • under a doctor’s care for any serious condition • taking any other drug When using this product • give with food or milk if stomach upset occurs • long term continuous use may increase the risk of heart attack or stroke Stop use and ask a doctor if • the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding. • stomach pain or upset gets worse or lasts • the child does not get any relief within first day (24 hours) of treatment • fever or pain gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms appear Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Purpose
Purpose Pain reliever/fever reducer
Do Not Use
Do not use • if the child has ever had an allergic reaction to any other pain reliever/fever reducer • right before or after heart surgery
When Using
When using this product • give with food or milk if stomach upset occurs • long term continuous use may increase the risk of heart attack or stroke
Stop Use & Ask a Doctor
Stop use and ask a doctor if • the child feels faint, vomits blood, or has bloody or black stools. These are signs of stomach bleeding. • stomach pain or upset gets worse or lasts • the child does not get any relief within first day (24 hours) of treatment • fever or pain gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms appear
Keep Out of Reach of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Storage & Handling
Other information • do not use if printed neckband is broken or missing • store at 20-25°C (68-77°F) • see bottom panel for lot number and expiration date
Questions
Questions or comments? 1-800-719-9260
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