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Acetaminophen
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Acetaminophen | 650 mg/1 | 313782 | View |
Forms, strengths and routes
Source: NDC DirectoryRegulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 211544-001 | ACETAMINOPHEN | TABLET, EXTENDED RELEASE | ACETAMINOPHEN | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 16 | Labeling | Approved | January 18, 2024 | Standard |
| Original application | 1 | Approved | April 16, 2019 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260410). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUses ■ temporarily relieves minor aches and pains due to: ■ minor pain of arthritis ■ muscular aches ■ backache ■ premenstrual and menstrual cramps ■ the common cold ■ headache ■ toothache ■ temporarily reduces fever
Purpose
openFDA Drug LabelingPurpose Pain reliever/fever reducer
Dosage and Administration
openFDA Drug LabelingDirections ■ d o not take more than directed (see overdose warning) adults and children 12 years of age and over ■ take 2 caplets every 8 hours with water ■ swallow whole; do not crush, chew, split or dissolve ■ do not take more than 6 caplets in 24 hours ■ do not use for more than 10 days unless directed by a doctor children under 12 years ■ do not use
Warnings and Cautions
openFDA Drug LabelingAllergy 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.
Warnings
openFDA Drug LabelingWarnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 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. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are allergic to acetaminophen or any of the inactive ingredients in this product. Ask a doctor before use if you have liver disease. Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. Stop use and ask a doctor if pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do Not Use
openFDA Drug LabelingDo not use • with any other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if you have liver disease.
Stop Use
openFDA Drug LabelingStop use and ask a doctor if • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present These could be signs of a serious condition.
Active Ingredient
openFDA Drug LabelingActive ingredient (in each caplet) Acetaminophen USP, 650 mg
Overdosage
openFDA Drug LabelingOverdose warning In case of overdose, get medical help or contact a poison control center right away.(1-800 222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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 |
|---|---|---|---|---|
| 69842-322-10 | 69842-322 | CVS PHARMACY INC | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69842-322-10) | February 1, 2021 |
| 69842-322-24 | 69842-322 | CVS PHARMACY INC | 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69842-322-24) | February 1, 2021 |
| 69842-297-10 | 69842-297 | CVS PHARMACY iNC | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69842-297-10) | February 1, 2021 |
| 69842-297-20 | 69842-297 | CVS PHARMACY iNC | 200 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69842-297-20) | January 30, 2020 |
| 69848-015-10 | 69848-015 | Granules USA, Inc. | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69848-015-10) | December 31, 2019 |
| 69848-015-24 | 69848-015 | Granules USA, Inc. | 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69848-015-24) | November 30, 2022 |
| 0113-4004-00 | 0113-4004 | L. Perrigo Company | 1 BAG in 1 DRUM (0113-4004-00) / 99280 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG | May 12, 2000 |
| 0113-4013-00 | 0113-4013 | L. Perrigo Company | 1 BAG in 1 DRUM (0113-4013-00) / 98400 TABLET, FILM COATED, EXTENDED RELEASE in 1 BAG | March 26, 2005 |
| 53329-643-29 | 53329-643 | Medline Industries, LP | 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53329-643-29) | July 10, 2018 |
| 72476-185-05 | 72476-185 | RETAIL BUSINESS SERVICES,LLC. | 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72476-185-05) | August 19, 2020 |
| 72476-185-10 | 72476-185 | RETAIL BUSINESS SERVICES,LLC. | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72476-185-10) | August 19, 2020 |
| 72476-185-21 | 72476-185 | RETAIL BUSINESS SERVICES,LLC. | 225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72476-185-21) | August 19, 2020 |
| 72476-186-05 | 72476-186 | RETAIL BUSINESS SERVICES,LLC. | 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72476-186-05) | August 19, 2020 |
| 72476-186-10 | 72476-186 | RETAIL BUSINESS SERVICES,LLC. | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (72476-186-10) | August 19, 2019 |
| 11822-5019-2 | 11822-5019 | RITE AID | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (11822-5019-2) | November 1, 2024 |
| 11822-5019-3 | 11822-5019 | RITE AID | 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (11822-5019-3) | November 1, 2024 |
| 11822-5019-4 | 11822-5019 | RITE AID | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (11822-5019-4) | November 30, 2021 |
| 11822-5091-5 | 11822-5091 | RITE AID | 225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (11822-5091-5) | November 1, 2024 |
| 11822-5091-6 | 11822-5091 | RITE AID | 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (11822-5091-6) | November 1, 2024 |
| 49035-181-21 | 49035-181 | WAL-MART STORES INC | 225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (49035-181-21) | October 4, 2019 |
| 0363-9992-10 | 0363-9992 | WALGREENS | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-9992-10) | September 28, 2019 |
| 0363-9992-20 | 0363-9992 | WALGREENS | 200 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-9992-20) | September 28, 2019 |
| 0363-9992-24 | 0363-9992 | WALGREENS | 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-9992-24) | September 28, 2019 |
| 0363-9993-15 | 0363-9993 | WALGREENS CO. | 150 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-9993-15) | September 28, 2019 |
| 0363-9993-21 | 0363-9993 | WALGREENS CO. | 225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0363-9993-21) | September 28, 2019 |
| 69842-322 | 69842-322 | CVS PHARMACY INC | — | February 1, 2021 |
| 69842-297 | 69842-297 | CVS PHARMACY iNC | — | January 30, 2020 |
| 69848-015 | 69848-015 | Granules USA, Inc. | — | December 31, 2019 |
| 0113-4004 | 0113-4004 | L. Perrigo Company | — | May 12, 2000 |
| 0113-4013 | 0113-4013 | L. Perrigo Company | — | March 26, 2005 |
| 53329-643 | 53329-643 | Medline Industries, LP | — | April 30, 2002 |
| 72476-185 | 72476-185 | RETAIL BUSINESS SERVICES,LLC. | — | August 19, 2020 |
| 72476-186 | 72476-186 | RETAIL BUSINESS SERVICES,LLC. | — | August 19, 2019 |
| 11822-5019 | 11822-5019 | RITE AID | — | November 1, 2024 |
| 11822-5091 | 11822-5091 | RITE AID | — | November 1, 2024 |
| 49035-181 | 49035-181 | WAL-MART STORES INC | — | October 4, 2019 |
| 0363-9992 | 0363-9992 | WALGREENS | — | September 28, 2019 |
| 0363-9993 | 0363-9993 | WALGREENS CO. | — | September 28, 2019 |
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.