Sunmark ibuprofen childrens 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 HIGH FRUCTOSE CORN SYRUP XANTHAN GUM opaque
Drug Facts
Composition & Profile
Identifiers & Packaging
Principal Display Panel See New Warnings Information Children’s ibuprofen oral suspension 100 mg per 5 mL (teaspoonful) Pain reliever, Fever reducer (NSAID) For ages 2 to 11 Lasts up to 8-hours Alcohol free FRUIT FLAVOR GLUTEN FREE Ibuprofen Oral Suspension Carton Image 1 Ibuprofen Oral Suspension Carton Image 1 Ibuprofen Oral Suspension Carton Image 2 Ibuprofen Oral Suspension Carton Image 1 Ibuprofen Oral Suspension Carton Image 2
- Principal Display Panel See New Warnings Information Children’s ibuprofen oral suspension 100 mg per 5 mL (teaspoonful) Pain reliever, Fever reducer (NSAID) For ages 2 to 11 Lasts up to 8-hours Alcohol free FRUIT FLAVOR GLUTEN FREE Ibuprofen Oral Suspension Carton Image 1 Ibuprofen Oral Suspension Carton Image 1 Ibuprofen Oral Suspension Carton Image 2 Ibuprofen Oral Suspension Carton Image 1 Ibuprofen Oral Suspension Carton Image 2
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. If possible, use weight to dose; otherwise use age. • use only 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 an NSAID, which may cause severe stomach bleeding. The chance is higher if your child • has had stomach ulcers or bleeding problems • takes a blood thinning (anticoagulant) or steroid drug • takes other drugs containing prescription or nonprescription NSAIDs (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 stomach bleeding warning applies to your child • child has a history of stomach problems, such as heartburn • child has not been drinking fluids • child has lost a lot of fluid due to vomiting or diarrhea • child has high blood pressure, heart disease, liver cirrhosis, or kidney disease • child has asthma • child is taking a diuretic Ask a doctor or pharmacist before use if the child is • 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 • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed Stop use and ask a doctor if • child experiences any of the following signs of stomach bleeding: • feels faint • vomits blood • has bloody or black stools • has stomach pain that does not get better • 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. (1-800-222-1222)
Purpose
Purposes 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 • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop Use & Ask a Doctor
Stop use and ask a doctor if • child experiences any of the following signs of stomach bleeding: • feels faint • vomits blood • has bloody or black stools • has stomach pain that does not get better • 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. (1-800-222-1222)
Storage & Handling
Other information • each teaspoon contains: sodium 2 mg • 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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