Active Ingredient Purpose(In Each 5 Ml)
Acetaminophen 160 mg ............... Pain reliever/fever reducer
The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product Acetaminophen (NDC 63868-677). 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(in each 5 ml), uses temporarily:, warnings, do not use, otc - ask doctor, otc - ask doctor/pharmacist, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 160 mg ............... Pain reliever/fever reducer
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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or
vomiting, consult a doctor promptly.
When using this product do not exceed recommended dose (see overdose warning)
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
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
If possible, use weight to dose; otherwise, use age.
Weight (Ib) | Age (yr) | Dose (mL) or as directed by doctor |
Under 24 | Under 2 years | Ask a doctor |
24-35 | 2-3 years | 5 mL |
Questions or comments?
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acesulfame potassium, avicel, citric acid, FD&C blue no. 1, FD&C red no. 33, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N & AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum
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