Childrens Ibuprofen bubblegum
Childrens Ibuprofen bubblegum is an FDA drug label for the active ingredient IBUPROFEN manufactured by Guardian Drug Company administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20211013.
- Generic name
- IBUPROFEN
- Manufacturer
- Guardian Drug Company
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 53041-572
- Application
- ANDA210149
- Label effective
- 20211013
Active ingredients
Indications & Usage
USE(S) 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 6-8 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 (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
Contraindications
Not available.
Warnings
WARNINGS Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives asthma (wheezing) skin reddening facial swelling shock 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.
Adverse Reactions
Not available.