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Feverall

Acetaminophen · Suppository

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Feverall Childrens
Generic name
Acetaminophen
Dosage form
Suppository
Route
Rectal
Marketing category
NDA · NDA
Labeler
Sun Pharmaceutical Industries, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
3
Packages
6
Data completeness
76% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Acetaminophen 120 mg/1 313782 View
Acetaminophen 325 mg/1 313782 View
Acetaminophen 80 mg/1 313782 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Suppository
Route of administration
Rectal
Presentations
9

Regulatory status

Source: Drugs@FDANDC Directory
Application number
018337
Application type
NDA · New Drug Application
Approval date
April 22, 1980
Sponsor
TARO
Products on application
4
Submissions recorded
15
Products approved under application 018337.
Product Trade name Form Strength Ingredient Status TE Flags
018337-001 ACETAMINOPHEN SUPPOSITORY ACETAMINOPHEN Discontinued — RLD
018337-002 ACETAMINOPHEN SUPPOSITORY ACETAMINOPHEN Over-the-counter — RLD
018337-003 ACETAMINOPHEN SUPPOSITORY ACETAMINOPHEN Over-the-counter — RLD
018337-004 INFANTS' FEVERALL SUPPOSITORY ACETAMINOPHEN Over-the-counter — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
No

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA
Most recent submissions on application 018337.
Type No. Action Status Date Review
Supplement 35 Labeling Approved February 7, 2020 Standard
Supplement 34 Labeling Approved August 12, 2015 Standard
Supplement 33 Manufacturing (CMC) Approved January 5, 2015 Standard
Supplement 32 Labeling Approved January 16, 2014 Standard
Supplement 29 Labeling Approved October 20, 2010 Standard
Supplement 28 Labeling Approved April 5, 2010 Standard
Supplement 25 Manufacturing (CMC) Approved June 27, 2008 N/A
Supplement 24 Manufacturing (CMC) Approved November 2, 2007 N/A
Supplement 20 Manufacturing (CMC) Approved October 9, 2002 Standard
Supplement 16 Manufacturing (CMC) Approved September 21, 2000 Standard
Supplement 15 Manufacturing (CMC) Approved June 15, 1994 Standard
Supplement 12 Manufacturing (CMC) Approved January 28, 1993 Standard
Supplement 13 Labeling Approved August 26, 1992 —
Supplement 8 Labeling Approved June 8, 1988 —
Original application 1 Type 5 - New Formulation or New Manufacturer Approved April 22, 1980 Standard

Review documents

  • 0 · Supplement · February 10, 2020
  • 0 · Supplement · February 10, 2020
  • 0 · Supplement · August 13, 2015
  • 0 · Supplement · August 13, 2015
  • 0 · Supplement · January 28, 2014
  • 0 · Supplement · January 17, 2014
  • 0 · Supplement · March 30, 2012
  • 0 · Supplement · April 8, 2010
  • 0 · Supplement · July 1, 2008
  • 0 · Supplement · November 8, 2007

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260903). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260903 HUMAN OTC DRUG · 20260724

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Purposes Pain reliever/fever reducer

Dosage and Administration

openFDA Drug Labeling

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

openFDA Drug Labeling

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if a child 6 to 12 years takes more than 5 doses in 24 hours an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount taken with other drugs containing acetaminophen an adult takes 3 or more alcoholic drinks every day while using this product 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 in children under 6 years 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 you have liver disease. you are taking the blood thinning drug warfarin. Stop use and ask a doctor if fever lasts more than 3 days (72 hours), or recurs. pain gets worse or lasts more than 10 days. new symptoms occur. redness or swelling is present in the painful area. These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. 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.

Do Not Use

openFDA Drug Labeling

Do not use in children under 6 years 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

openFDA Drug Labeling

Ask a doctor before use if the child has liver disease. the child is taking the blood thinning drug warfarin.

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if fever lasts more than 3 days (72 hours), or recurs. pain gets worse or lasts more than 10 days. new symptoms occur. redness or swelling is present in the painful area. These may be signs of a serious condition.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each rectal suppository) Acetaminophen, USP 325 mg

Adverse event reports

Source: openFDA FAERS
679,519
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: ACETAMINOPHEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
51672-2114-2 51672-2114 Sun Pharmaceutical Industries, Inc. 6 BLISTER PACK in 1 CARTON (51672-2114-2) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2114-0) December 12, 2013
51672-2114-4 51672-2114 Sun Pharmaceutical Industries, Inc. 50 BLISTER PACK in 1 CARTON (51672-2114-4) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2114-0) December 12, 2013
51672-2115-2 51672-2115 Sun Pharmaceutical Industries, Inc. 6 BLISTER PACK in 1 CARTON (51672-2115-2) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2115-0) December 12, 2013
51672-2115-4 51672-2115 Sun Pharmaceutical Industries, Inc. 50 BLISTER PACK in 1 CARTON (51672-2115-4) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2115-0) December 12, 2013
51672-2116-2 51672-2116 Sun Pharmaceutical Industries, Inc. 6 BLISTER PACK in 1 CARTON (51672-2116-2) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2116-0) December 12, 2013
51672-2116-4 51672-2116 Sun Pharmaceutical Industries, Inc. 50 BLISTER PACK in 1 CARTON (51672-2116-4) / 1 SUPPOSITORY in 1 BLISTER PACK (51672-2116-0) December 12, 2013
51672-2114 51672-2114 Sun Pharmaceutical Industries, Inc. — December 12, 2013
51672-2115 51672-2115 Sun Pharmaceutical Industries, Inc. — December 12, 2013
51672-2116 51672-2116 Sun Pharmaceutical Industries, Inc. — December 12, 2013

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.