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Drug Facts
Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
The following Structured Product Label (SPL) was submitted to the FDA by Taro Pharmaceuticals U.s.a., Inc. for the product Feverall (NDC 51672-5320). 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), purposes, uses, liver warning, sore throat warning, do not use, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Acetaminophen 160 mg
Pain reliever/fever reducer
temporarily:
This product contains acetaminophen. Severe liver damage may occur if your child takes:
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.
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)
These could be signs of a serious condition.
Keep out of reach of children.
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.
| Weight (lb) | Age (yr) | Dose (mL) or as directed by a doctor |
|---|---|---|
| under 24 | under 2 years | ask a doctor |
| 24-35 lbs | 2-3 years | 5 mL |
| 36-47 lbs | 4-5 years | 7.5 mL |
| 48-59 lbs | 6-8 years | 10 mL |
| 60-71 lbs | 9-10 years | 12.5 mL |
| 72-95 lbs | 11 years | 15 mL |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
anhydrous citric acid, butylparaben, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum
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