Active Ingredient
(in each 5.0 mL)
Acetaminophen 160mg
The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc. for the product Little Fevers Infant Berry Fever/pain Reliever (NDC 63029-622). 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, ask a doctor before use, ask a doctor or pharmacist before use, do not use:, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
(in each 5.0 mL)
Acetaminophen 160mg
Pain Reliever/Fever Reducer
Temporarily:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes
if your child has liver disease.
if your child is taking the blood thinning drug warfarin.
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.
DO NOT EXCEED RECOMMENDED DOSAGE; taking more than the recommended dose (overdose) may not provide more relief and may cause liver damage.
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.
This product does not contain directions or complete warnings for adult use.
| Weight (lbs) | Age (yrs) | Dose |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 | 5.0 mL |
| 36-47 | 4-5 | 7.5 mL |
Citric Acid, Glycerin, High Fructose Corn Syrup, Natural Flavors, Polyethylene Glycol, Propylene Glycol, Purified Water, Sodium Benzoate and Sucralose
For further information you may contact us at: 1-800-7-LITTLE Mon. – Fri. 8:00 a.m.to 8:00 p.m. EST, or visit us at www.LittleRemedies.com.
MEDICATED FOR INFANTS
Little Fevers® by Little Remedies®
NEW! AccuSafeTM System
INFANT FEVER/PAIN RELIEVER
Acetaminophen
DYE-FREE
NO ARTIFICIAL FLAVORS
NO ALCOHOL, SACCHARIN OR DYES
GLUTEN FREE!
Natural BERRY Flavor
SEE NEW DOSING INFORMATION.
2 FL. OZ. (59 mL)
* Please review the disclaimer below.