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 Childrens Fever Pain Reliever (NDC 63029-603). 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, ask a doctor before use, ask a doctor or pharmacist before use, when using this product, 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.
if your child has liver disease.
if the child is taking the blood thinning drug warfarin.
do not exceed recommended dosage (see overdose warning).
These could be signs of a serious condition.
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 right away (1-800-222-1222). Prompt medical attention is critical even if you do not notice any signs of symptoms.
This product does not contain directions or complete warnings for adult use.
| Weight (lb) | Age (yr) | Dose |
| Under 24 | under 2 | Ask a doctor |
| 24-35 | 2 – under 4 | 5mL |
| 36-47 | 4 – under 6 | 7.5mL |
| 48-59 | 6 – under 9 | 10 mL |
| 60-71 | 9 – under 11 | 12.5mL |
| 72-95 | 11 – under 12 | 15mL |
citric acid, glycerin, natural flavors, potassium sorbate, povidone, propylene glycol, purified water, sodium citrate, sucralose, sucrose, xanthan gum
1-800-754-8853
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Little Remedies®
CHILDREN’S FEVER + PAIN RELIEVER
Acetaminophen
NATURAL CHERRY FLAVOR
4 FL OZ (118 mL)
Little Remedies®
CHILDREN’S FEVER + PAIN RELIEVER
Acetaminophen
NATURAL GRAPE FLAVOR
4 FL OZ (118 mL)
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