Active Ingredient
(in each 5 mL)
Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Little Remedies Infant Fever/pain Reliever (NDC 63029-610). 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 active ingredient, purpose, uses, warnings, do not use:, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each 5 mL)
Acetaminophen 160 mg
Pain Reliever/Fever Reducer
Temporarily:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If skin reaction occurs, stop use and seek medical help right away.
Sore Throat Warning: If sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
Overdose Warning: Taking more than the recommended dose (overdose) can cause serious liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms.
mL=mililiter
| Weight (lbs) | Age (yrs) | Dose |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 | 5 mL |
benzoic acid, carboxymethlcellulose, glycerin, natural berry flavor, microcrystalline cellulose, sucrose, sodium benzoate, water, xanthan gum
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