Active Ingredient (In Each Chewable Tablet)
Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Childrens Chewables (NDC 70677-1127). 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 (in each chewable tablet), purpose, uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 160 mg
Pain reliever/fever reducer
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 a 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
liver disease.
taking the blood thinning drug warfarin.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| Weight (lb) | Age (yr) | Dose (chewable tablets)* |
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 | 1 tablet |
| 36-47 | 4-5 | 1 1/2 tablets |
| 48-59 | 6-8 | 2 tablets |
| 60-71 | 9-10 | 2 1/2 tablets |
| 72-95 | 11 | 3 tablets |
*or as directed by a doctor
citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, flavor, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose
Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST
NDC 70677-1127-1
Foster & Thrive™
COMPARE TO
CHILDREN’S TYLENOL® CHEWABLES
ACTIVE INGREDIENT**
Children’s Chewables
Acetaminophen 160 mg
Chewable Tablets
PAIN RELIEVER/FEVER REDUCER
Ibuprofen Free
Ages 2-11
Aspirin Free
Bubble Gum Flavored
ACTUAL SIZE
24 CHEWABLE TABLETS
Chew or crush tablets completely before swallowing.
* Please review the disclaimer below.