Childrens Ibuprofen Ibuprofen IBUPROFEN IBUPROFEN CITRIC ACID MONOHYDRATE FD&C RED NO. 40 GLYCERIN HYPROMELLOSE, UNSPECIFIED POLYSORBATE 80 WATER SODIUM BENZOATE SUCROSE XANTHAN GUM light
Drug Facts
Composition & Profile
Identifiers & Packaging
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Compare to the active ingredient in Children’s Motrin( Bubble Gum* NDC 63187-166-18 For ages 2 to 11 CHILDREN’S Ibuprofen Oral Suspension, USP (NSAID) 100 mg per 5 mL (teaspoon) Pain Reliever Fever Reducer Lasts up to 8 hours Bubble Gum Flavor Alcohol Free 4 FL OZ (118 mL) 12630112F1 VC100162 63187-166-18
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Compare to the active ingredient in Children’s Motrin( Bubble Gum* NDC 63187-166-18 For ages 2 to 11 CHILDREN’S Ibuprofen Oral Suspension, USP (NSAID) 100 mg per 5 mL (teaspoon) Pain Reliever Fever Reducer Lasts up to 8 hours Bubble Gum Flavor Alcohol Free 4 FL OZ (118 mL) 12630112F1 VC100162 63187-166-18
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 • 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 Dosing Chart Weight (lb) Age (yr) Dose (tsp 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 1½ tsp or 7.5 mL 48 – 59 lbs 6 – 8 years 2 tsp or 10 mL 60 – 71 lbs 9 – 10 years 2½ tsp or 12.5 mL 72 – 95 lbs 11 years 3 tsp or 15 mL Other information • each teaspoon contains: sodium 2 mg • do not use if printed neckband is broken or missing • store between 20 - 25°C (68 - 77°F) • see bottom panel for lot number and expiration date
Warnings & Precautions
WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: • hives • shock • asthma (wheezing) • rash • skin reddening • blisters • facial swelling 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.
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 • take 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 the 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).
Questions
QUESTIONS? 1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.
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