Feverall Infants

Feverall Infants is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN. It is labelled by Sun Pharmaceutical Industries, Inc. taken by rectal and marketed as a human otc drug product. Identifiers on file: NDC 51672-2114, application NDA018337, label effective 20260724. It is one of 274 FDA drug label records sharing the active ingredient ACETAMINOPHEN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ACETAMINOPHEN are most often described in connection with: temporarily reduces, fever relieves, minor aches. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses temporarily reduces fever relieves minor aches, pains, and headache

Directions this product does not contain directions or warnings for adult use do not use more than directed remove wrapper carefully insert suppository well up into the rectum Dosing Chart Age Dose under 6 months Do not use unless directed by a doctor 6 to 11 months Use 1 suppository every 6 hours (maximum of 4 doses in 24 hours) 12 to 36 months Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if your child takes more than 4 doses in 24 hours, which is the maximum daily amount for ages 6 to 11 months more than 5 doses in 24 hours, which is the maximum daily amount for ages 12 to 36 months with other drugs containing acetaminophen Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. For rectal use only. Do not use if you are allergic to acetaminophen. 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 the child has liver disease. the child is taking the blood thinning drug warfarin. Stop use and ask a doctor if fever lasts more than 3 days (72 hours), or recurs. pain lasts more than 3 days or gets worse. new symptoms occur. redness or swelling is present in the painful area. These may be signs of a serious condition. Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

FDA lists 274 drug label records with ACETAMINOPHEN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Feverall Infants used for?
Uses temporarily reduces fever relieves minor aches, pains, and headache

Who makes Feverall Infants?
Sun Pharmaceutical Industries, Inc. is the labeler of record for Feverall Infants. 274 FDA label records share the active ingredient ACETAMINOPHEN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Feverall Infants come in?
administered by rectal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Feverall Infants prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ACETAMINOPHEN?
Yes. 274 FDA drug label records list ACETAMINOPHEN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Feverall Infants been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.