Active Ingredient (In Each Chewable Tablet)
Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Discount Drug Mart for the product Childrens Chewable Acetaminophen (NDC 53943-449). 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, when using this product, 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.
liver disease.
taking the blood thinning drug warfarin.
do not exceed recommended dosage.
These could be signs of a serious condition.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol,
polyethylene, stearic acid, sucralose
1-800-426-9391
NDC 53943-449-08
Discount
Drug
Mart
Food Fair
Ages 2-11
Children's Chewable Acetaminophen
160 mg Chewable Tablets ι Pain Reliever/Fever Reducer
Aspirin Free
Ibuprofen Free
Actual Size
Grape Flavor
†Compare to the active ingredient of CHILDREN'S TYLENOL®
24 CHEWABLE TABLETS
Chew or crush tablets completely before swallowing.
†This product is not manufactured or distributed
by Johnson & Johnson Corporation, owner of the
registered trademark Children’s Tylenol®.
50844 ORG101844908
DISTRIBUTED BY: DRUG MART - FOOD FAIR
211 COMMERCE DRIVE, MEDINA, OH 44256
www.discount-drugmart.com
SATISFACTION GUARANTEED
IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE
TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO
STORE, SEND REASON FOR DISSATISFACTION, NAME,
ADDRESS AND EMPTY PACKAGE TO:
DISCOUNT DRUG MART
211 COMMERCE DRIVE, MEDINA, OHIO 44256
TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING
* Please review the disclaimer below.