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Acetaminophen

Over-the-counter ANDA 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
acetaminophen for children
Generic name
Acetaminophen
Dosage form
Suppository
Route
Rectal
Marketing category
ANDA · ANDA
Labeler
Padagis Israel Pharmaceuticals Ltd
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
6
Packages
9
Data completeness
82% 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 650 mg/1 313782 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Suppository
Route of administration
Rectal
Presentations
15

Regulatory status

Source: Drugs@FDANDC Directory
Application number
070607
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 6, 1987
Sponsor
PERRIGO NEW YORK
Products on application
1
Submissions recorded
6
Products approved under application 070607.
Product Trade name Form Strength Ingredient Status TE Flags
070607-001 ACETAMINOPHEN SUPPOSITORY ACETAMINOPHEN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 070607.
Type No. Action Status Date Review
Supplement 8 Labeling Approved September 24, 2015 Standard
Supplement 7 Labeling Approved June 8, 2011 —
Supplement 6 Labeling Approved August 6, 2010 —
Supplement 3 Labeling Approved August 31, 1992 —
Supplement 2 Manufacturing (CMC) Approved October 23, 1987 —
Original application 1 Approved April 6, 1987 —

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250212). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250212 HUMAN OTC DRUG · 20240604 HUMAN OTC DRUG · 20220901

Indications and Usage

openFDA Drug Labeling

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

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 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 Liver warning: This product contains acetaminophen. Severe liver damage may occur if • 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 12 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. (1-800-222-1222) 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 • in children under 12 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 • your child has liver disease • your 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 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 120 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
68071-4151-1 68071-4151 NuCare Pharmaceutiacals,Inc. 12 SUPPOSITORY in 1 BOX (68071-4151-1) November 8, 2017
68071-4172-6 68071-4172 NuCare Pharmaceuticals,Inc. 6 SUPPOSITORY in 1 BLISTER PACK (68071-4172-6) December 4, 2017
45802-730-00 45802-730 Padagis Israel Pharmaceuticals Ltd 1 SUPPOSITORY in 1 BLISTER PACK (45802-730-00) October 28, 2010
45802-730-30 45802-730 Padagis Israel Pharmaceuticals Ltd 12 BLISTER PACK in 1 CARTON (45802-730-30) / 1 SUPPOSITORY in 1 BLISTER PACK October 28, 2010
45802-730-32 45802-730 Padagis Israel Pharmaceuticals Ltd 50 BLISTER PACK in 1 CARTON (45802-730-32) / 1 SUPPOSITORY in 1 BLISTER PACK November 22, 2010
45802-730-33 45802-730 Padagis Israel Pharmaceuticals Ltd 100 BLISTER PACK in 1 CARTON (45802-730-33) / 1 SUPPOSITORY in 1 BLISTER PACK October 28, 2010
45802-732-30 45802-732 Padagis Israel Pharmaceuticals Ltd 12 BLISTER PACK in 1 CARTON (45802-732-30) / 1 SUPPOSITORY in 1 BLISTER PACK March 9, 2011
45802-732-33 45802-732 Padagis Israel Pharmaceuticals Ltd 100 BLISTER PACK in 1 CARTON (45802-732-33) / 1 SUPPOSITORY in 1 BLISTER PACK December 14, 2010
63187-373-12 63187-373 Proficient Rx LP 12 BLISTER PACK in 1 CARTON (63187-373-12) / 1 SUPPOSITORY in 1 BLISTER PACK September 1, 2016
50090-0001 50090-0001 A-S Medication Solutions — December 14, 2010
68071-4151 68071-4151 NuCare Pharmaceutiacals,Inc. — December 14, 2010
68071-4172 68071-4172 NuCare Pharmaceuticals,Inc. — December 14, 2010
45802-730 45802-730 Padagis Israel Pharmaceuticals Ltd — October 28, 2010
45802-732 45802-732 Padagis Israel Pharmaceuticals Ltd — December 14, 2010
63187-373 63187-373 Proficient Rx LP — December 14, 2010

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.