Active Ingredient (In Each Tablet)
Acetaminophen 80 mg
Childrens Chewable Acetaminophen Tablet, Chewable
FDA Label NDC 57896-148
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geri-care Pharmaceutical Corp for the product Childrens Chewable Acetaminophen (NDC 57896-148). 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 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.
Label Section Quick Index
Purpose
Pain reliever/fever reducer
Uses
- temporarily relieves minor aches and pains
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- skin reddening
- blisters
- rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
Do Not Use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
Ask A Doctor Before Use If Your Child Has
liver disease.
Ask A Doctor Or Pharmacist Before Use If Your Child Is
taking the blood thinning drug warfarin.
Stop Use And Ask A Doctor If
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- redness or swelling is present
These could be signs of a serious condition.
Keep Out Of Reach Of Children.
Overdose warning: In case of overdose, get medical
help or contact a Poison Control Center right away.
Quick medical attention is critical for adults as well as for
children even if you do not notice any signs or symptoms.
Directions
Chew tablets thoroughly before swallowing.
This product does not contain directions or complete
warnings for adults.
Follow dosage on table or use as doctor directs. If possible
use weight to dose; otherwise use age. Give every 4 hours
as needed; do not give more than 5 doses in 24 hours.
Administer only under adult supervision.
DO NOT EXCEED DOSE SHOWN
See Overdose Warning.
Weight (lb) | Under 24 | 24-35 | 36-47 | 48-59 | 60-71 | 72-95 |
| Age | Under 2
| 2-3 | 4-5 | 6-8 | 9-10 | 11 |
| Tablets | Ask a doctor | 2 | 3 | 4 | 5 | 6 |
Other Information
- TAMPER EVIDENT: Do not use if imprinted seal under cap is missing or broken.
- store at 20°C-25°C (68°F-77°F)F); avoid high humidity
- Keep tightly closed
- Phenylketonurics: contains phenylalanine 5mg per tablet.
Inactive Ingredients
Aspartame (contains phenylalanine), cellulose, D&C Red #27, Dextrose, FD&C Yellow #6, fruit flavor, magnesium stearate,
Prosweet, stearic acid, sugar
Principal Display Panel
1 (148hst)
* Please review the disclaimer below.
