Active Ingredient
Acetaminophen 80 mg
Childrens Pain Relief
FDA Label NDC 69168-023
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allegiant Health for the product Childrens Pain Relief (NDC 69168-023). 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, liver warning, sore throat warning, do not use, ask doctor before use if your child has, ask doctor or pharmacist before use if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Analgesic/Antipyretic
Uses
temporary relief of minor aches and pains associated with common cold and flu headache toothache sore throat immunizations and reduction of fever
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen
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
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
Ask Doctor Before Use If Your Child Has
liver disease
Ask Doctor Or Pharmacist Before Use If
the user is taking the blood thinning drug warfarin
When Using This Product
do not exceed recommended dose; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems
Stop Use And Ask A Doctor If
symptoms do not improve pain gets worse or lasts more than 5 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present You may report side effects to 888-952-0050
Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms
Directions
this product does not contain directions or complete warnings for adult usechew tablets before swallowing all dosages may be repeated every 4 hours, but not more than 5 doses in a 24 hour period follow the chart below for proper dosing or as directed by a doctor if possible, use weight for dosing, otherwise use age
Weight (lbs) | Under 24 | 24-35 | 36-47 | 48-59 | 60-71 | 72-95 |
Age (yrs) | Under 2 | 2-3 | 4-5 | 6-8 | 9-10 | 11 |
Tablets | Consult a doctor | 2 | 3 | 4 | 5 | 6 |
Other Information
Phenylketonurics: contains phenylalanine 2.8 mg per tablet store at room temperature protect from excessive moisture do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients
aspartame, croscarmellose sodium, D&C red #7, flavors, mannitol, microcrystalline cellulose, silicon dioxide, stearic acid, sucrose
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