Otc - Active Ingredient
Active ingredient (per 5mL teaspoonful)
Acetaminophen 160 mg
Acetaminophen
FDA Label NDC 72091-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Samjan Group Inc. for the product Acetaminophen (NDC 72091-004). 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 otc - active ingredient, otc - purpose, uses, warnings, do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Pain Reliever / Fever Reducer
Uses
temporarily • relieves minor aches • 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 • taken with other drugs containing acetaminophen
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include: • skin reddening • blisters • rash
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
Otc - Ask Doctor
Ask a doctor before use if your child has a liver disease.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
Otc - When Using
When using this product: Do not exceed recommended dose.
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.
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
• do not take more than directed
This product does not contain directions or complete warnings for adult use.
• find dose in chart below, if possible, use weight to dose, otherwise use age
• dosage may be repeated every 4 hours as needed, or as directed by a doctor
• do not give more than 5 doses in 24 hours • 5 milliliters (mL) = 1 teaspoon
Weight (lb) | Under 24 | 24-36 | 36-47 | 48-59 | 60-71 | 72-95 |
age (yr) | Under 2 | 2-3 | 4-5 | 6-8 | 9-10 | 11 |
Dosage (mL) | ask a doctor | 5 mL | 7.5 mL | 10 mL | 12.5 mL | 15 mL |
Other Information
• each teaspoonful (5 mL) contains: sodium 7.9 mg
• store at room temperature 15°- 30°C (59°-86°F)
• protect from freezing • protect from light
• TAMPER-EVIDENT: Do not use if imprinted seal under cap is broken or missing.
Inactive Ingredients:
artificial cherry flavor, citric acid, FD&C Red #40, glycerin, PEG, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol.
Principal Display Panel
• Compare To Active ingredient of Children's Tylenol
NDC 72091-004-01
Children's Liquid
Pain Reliever and Fever Reducer
Acetaminophen 160 mg/5mL
• Asprin Free
• Alcohol Free
• For Children Ages 2 - 11 years
Fruit Flavor
8 FL OZ (237 mL)
Apap (Apap)
* Please review the disclaimer below.
