Concentrated ibuprofen infants
Concentrated ibuprofen infants is an FDA drug label for the active ingredient IBUPROFEN manufactured by Chain Drug Marketing Association Inc. 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 20231103.
- Generic name
- IBUPROFEN
- Manufacturer
- Chain Drug Marketing Association Inc.
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 83324-005
- Application
- ANDA210755
- Label effective
- 20231103
Active ingredients
Indications & Usage
USE(S) temporarily: reduces fever relieves minor aches and pains due to the common cold, flu, sore throat, headaches and toothaches
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 below. If possible, use weight to dose; otherwise use age. mL=milliliter measure with dosing device provided. Do not use any other device. dispense liquid slowly into the child's mouth, toward the inner cheek if needed, repeat dose every 6-8 hours do not use more than 4 times a day Dosing Chart WEIGHT (lb) AGE (mos) DOSE (mL) under 6 mos ask a doctor 12-17 lbs 6-11 mos 1.25 mL 18-23 lbs 12-23 mos 1.875 mL
Contraindications
Not available.
Warnings
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 you 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.