Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameACETAMINOPHEN
Labeler / manufacturerSun Pharmaceutical Industries, Inc.
RouteRECTAL
Drug classDrug class not supplied in source label
Product NDC51672-2115
Label effective date2026-08-24
Official product label reference
Feverall Childrens — Sun Pharmaceutical Industries, Inc.
This page contains 13 source sections for ACETAMINOPHEN, rectal route. Label set 861e2987-5473-45b0-b2a6-f980a9b0e809, version 8.
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
Uses temporarily reduces fever relieves minor aches, pains, and headache
Purpose
Purposes Pain reliever/fever reducer
Dosage and administration — label text
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 3 years Do not use unless directed by a doctor 3 to 6 years Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
Table text from source:
Dosing Chart
| Age | Dose
| under 3 years | Do not use unless directed by a doctor
| 3 to 6 years | Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
Warnings
Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount 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 5 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.
Unclassified section
Drug Facts
Dist. by: Ohm Laboratories, Inc. New Brunswick, NJ 08901
Active ingredient
Active ingredient (in each rectal suppository) Acetaminophen, USP 120 mg
Do not use
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
Ask a doctor before use if the child has liver disease. the child is taking the blood thinning drug warfarin.
When to stop use and seek help
Stop use and ask a doctor if fever lasts more than 3 days (72 hours), or recurs. pain lasts more than 5 days or gets worse. new symptoms occur. redness or swelling is present in the painful area. These may be signs of a serious condition.
Child safety
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.
Storage and handling
Other information store at 2°-27°C (35°-80°F) do not use if imprinted suppository wrapper is opened or damaged
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.