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Acetaminophen
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 070607-001 | ACETAMINOPHEN | SUPPOSITORY | ACETAMINOPHEN | Over-the-counter | — |
Approval history
Source: Drugs@FDA| 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 LabelingReproduced 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.
Indications and Usage
openFDA Drug LabelingUses temporarily • reduces fever • relieves minor aches, pains, and headache
Purpose
openFDA Drug LabelingPurposes Pain reliever/fever reducer
Dosage and Administration
openFDA Drug LabelingDirections • 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
openFDA Drug LabelingWarnings 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
openFDA Drug LabelingDo 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 LabelingAsk a doctor before use if • your child has liver disease • your child is taking the blood thinning drug warfarin
Stop Use
openFDA Drug LabelingStop 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 LabelingActive ingredient (in each rectal suppository) Acetaminophen 120 mg
Adverse event reports
Source: openFDA FAERSAttributed 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| 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
| 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.