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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
Generic name
Acetaminophen
Dosage form
Tablet, Film Coated, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
RITE AID
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
13
Packages
25
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 650 mg/1 313782 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated, Extended Release
Route of administration
Oral
Presentations
38

Regulatory status

Source: Drugs@FDANDC Directory
Application number
211544
Application type
ANDA · Abbreviated New Drug Application
Approval date
April 16, 2019
Sponsor
GRANULES
Products on application
1
Submissions recorded
2
Products approved under application 211544.
Product Trade name Form Strength Ingredient Status TE Flags
211544-001 ACETAMINOPHEN TABLET, EXTENDED RELEASE ACETAMINOPHEN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 211544.
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 Labeling

Reproduced 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.

HUMAN OTC DRUG · 20260410 HUMAN OTC DRUG · 20251219 HUMAN OTC DRUG · 20251219 HUMAN OTC DRUG · 20250116

Indications and Usage

openFDA Drug Labeling

Uses ■ 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 Pain reliever/fever reducer

Dosage and Administration

openFDA Drug Labeling

Directions ■ 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 Labeling

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.

Warnings 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 • 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 Labeling

Ask a doctor before use if you have liver disease.

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.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each caplet) Acetaminophen USP, 650 mg

Overdose 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 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
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

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.