Drug Facts
Composition & Profile
Identifiers & Packaging
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Container Label NDC 68001-521-92 For Ages 2 to 11 Years Children’s Ibuprofen Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Lasts up to 8 hours Alcohol Free Berry Flavor 4 FL OZ (120 mL) label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Carton Label NDC 68001-521-92 # Compare to the active ingredient in Children's Motrin ® For Ages 2 to 11 Years Children’s Ibuprofen Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Lasts up to 8 hours Alcohol Free Berry Flavor 4 FL OZ (120 mL) Carton
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Container Label NDC 68001-521-92 For Ages 2 to 11 Years Children’s Ibuprofen Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Lasts up to 8 hours Alcohol Free Berry Flavor 4 FL OZ (120 mL) label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL) Carton Label NDC 68001-521-92 # Compare to the active ingredient in Children's Motrin ® For Ages 2 to 11 Years Children’s Ibuprofen Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer (NSAID) Lasts up to 8 hours Alcohol Free Berry Flavor 4 FL OZ (120 mL) 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 shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed dosing cup. Do not use any other dosing device. if needed, repeat dose every 6 to 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 * or as directed by a doctor Weight (lb) Age (year) Dose (mL)* under 24 under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 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 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.
Purpose
Purpose Pain reliever/fever reducer *nonsteroidal anti-inflammatory drug
Do Not Use
Do not use if the child has ever had an allergic reaction to ibuprofen or 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
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 child has symptoms of heart problems or stroke: chest pain trouble breathing weakness in one part or side of body slurred speech leg swelling 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 5 mL contains: sodium 2 mg store between 20 to 25°C (68 to 77°F) do not use if carton is opened or seal under cap opening is broken or missing see bottom panel for lot number and expiration date
Questions
Questions or comments? Call 1-855-274-4122 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India For BluePoint Laboratories Made in India Code: TS/DRUGS/19/1993
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