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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Advagen Pharma Ltd. for the product Childrens Ibuprofen (NDC 72888-479). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each 5 ml), purpose, uses, warnings, do not use, ask a doctor before use if, ask a doctor or pharmacist before use if the child is, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Ibuprofen USP 100 mg (NSAID) *
*nonsteroidal anti-inflammatory drug
Pain reliever/fever reducer
temporarily:
Allergy alert
Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include:
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:
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.
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)
Dosing Chart
Weight (lb) | Age (yr) | 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 |
*or as directed by a doctor
acesulfame potassium, anhydrous citric acid, glycerine, orange flavor, polysorbate 80, pregelatinized starch, purified water, sodium benzoate, sucrose, xanthan gum
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Children’s Ibuprofen Oral Suspension (NSAID) 100 mg per 5 mL - NDC 72888-479-01 - 120 mL Carton Label
Children’s Ibuprofen Oral Suspension (NSAID) 100 mg per 5 mL - NDC 72888-479-01 - 120 mL Bottle Label
* Please review the disclaimer below.