Otc - Active Ingredient
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
The following Structured Product Label (SPL) was submitted to the FDA by Aarna Usa Inc. for the product Children Acetaminophen (NDC 82568-0008). 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, indications & usage, warnings, otc - keep out of reach of children, otc - pregnancy or breast feeding, other, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient (in each 5 mL)
Acetaminophen 160 mg
Purpose
Pain Reliever/Fever Reducer
Uses temporarily
Warnings
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:
Soar throat warning: if sore throat is severe, persists 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
Keep out of reach of children.
If pregnant or breast-feeding, ask a health professional before use
Overdose warning. In case of overdose, get medical help or contact a Paoison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
| Weight (lbs.) | Age (yrs.) | Dose (tsp or mL) |
| under 24 | under 2 | ask a doctor |
| 24 to 35 | 2 to 3 | 1 tsp or 5 mL |
| 36 to 47 | 4 to 5 | 1 1/2 tsp or 7.5 mL |
| 48 to 59 | 6 to 8 | 2 tsp or 10 mL |
| 60 to 71 | 9 to 10 | 2 1/2 tsp or 12.5 mL |
| 72 to 95 | 11 | 3 tsp or 15 mL |
Other Information store at room temperature 20o-25oC (68o-77oF). Protect from Freezing. Protect from light.
Inactive ingredients: Anhydrous Citric Acid, Bubble gum flavor, FD&C Red No 40, Glycerin, Polyethylene Glycol 400, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.
Questions or comments? 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 Eixir.
* Please review the disclaimer below.