Active Ingredient
Active ingredient(in each 5mL)
Purpose
Acetaminophen 160 mg ………………………….........Pain reliever/fever reducer
The following Structured Product Label (SPL) was submitted to the FDA by Aarna Usa Inc. for the product Childrens Acetaminophen (NDC 82568-0011). 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, uses, warnings, ask a doctor or pharmacist before use if the child has, ask doctor or pharmacist before use if your child is, stop use and ask a doctor if, overdose warning:, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient(in each 5mL)
Purpose
Acetaminophen 160 mg ………………………….........Pain reliever/fever reducer
temporarily: reduces fever
relieves minor aches and pains due to:
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, persist or more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
Do not use
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.
When using this product, do not exceed recommended dose (see overdose warning)
Stop use and ask a doctor if
Overdose warning:
In case of overdose, get medical help to contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Keep out of Reach of children
liver disease.
taking the blood thinning drug warfarin. When using this product do not exceed recommended dose (see overdose warning)
In case of overdose, get medical help to contact Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
| Weight (lbs) | Age (yrs.) | Dose (tsp or mL) | Weight (lbs) | Age (yrs.) | Dose (tsp or mL) |
| under 24 | under 2 | ask a doctor | 48 to 59 | 6 to 8 | 2 tsp or 10 mL |
| 25 to 35 | 2 to 3 | 1 tsp or 5 mL | 60 to 71 | 9 to 10 | 2 1/2 tsp or 12.5 mL |
| 36 to 47 | 4 to 5 | 1 1/2 tsp or 7.5 mL | 72 to 95 | 11 | 2 1/2 tsp or 12.5 mL |
Anhydrous Citric Acid, Cherry Flavor, Glycerin, Microcrystalline cellulose and Sodium Methyl Cellulose, Potassium Sorbate, Purified Water, Sorbitol, Sucralose, Sucrose, Xanthan gum.
call toll-free 1-877-225-6999
Manufactured for:
AARNA USA INC.
Leland, NC-28451
This product is not manufactured by or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Suspension.
* Please review the disclaimer below.