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Drug Facts
The following Structured Product Label (SPL) was submitted to the FDA by Westminster Pharmaceuticals, Llc for the product Acetaminophen (NDC 69367-323). 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 other, active ingredient (in each 5 ml teaspoonful), purpose, uses, liver warning, allergy alert, sore throat warning, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Acetaminophen, USP 160 mg
Pain reliever/fever reducer
For the temporary relief of minor aches and pains associated with:
This product contains acetaminophen. Severe liver damage may occur if your child takes:
Acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
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.
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.
Ask a doctor before use if your child has liver disease.
if your child is taking the blood thinning drug warfarin.
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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| Weight (lbs.) | Age (years) | Dosage Teaspoonful (tsp) or as directed by a doctor |
|---|---|---|
| Under 24 | Under 2 | Consult a doctor |
| 24 to 35 | 2 to under 4 | 5 mL (1 tsp) |
| 36 to 47 | 4 to under 6 | 7.5 mL (1 1/2 tsp) |
| 48 to 59 | 6 to under 9 | 10 mL (2 tsp) |
| 60 to 71 | 9 to under 11 | 12.5 mL (2 1/2 tsp) |
| 72 to 95 | 11 to under 12 | 15 mL (3 tsp) |
Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution, Sucralose.
You may report side effects by calling Westminster M-F (9 a.m. to 5 p.m. EST), at 1-844-221-7294 or FDA at 1-800-FDA-1088.
* Please review the disclaimer below.