Active Ingredient Purpose
Acetaminophen 160 mg............. Pain reliever/fever reducer
The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Acetaminophen (NDC 69729-028). 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, warnings, do not use, directions, other information, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 160 mg............. Pain reliever/fever reducer
temporarily:
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if your child takes 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.
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 |
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acesulfame potassium, avicel, citric acid, FD&C red no. 40, flavor, glycerine, high fructose corn syrup, polysorbate, propylene glycol, prosweet N&AK, purified water, sodium benzoate, sucralose, sorbitol, xanthan gum.
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