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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, Extended Release
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Granules India Limited
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
1
NDC product codes
25
Packages
86
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, Extended Release
Route of administration
Oral
Presentations
111

Regulatory status

Source: Drugs@FDANDC Directory
Application number
207229
Application type
ANDA · Abbreviated New Drug Application
Approval date
November 9, 2016
Sponsor
AUROBINDO PHARMA
Products on application
1
Submissions recorded
5
Products approved under application 207229.
Product Trade name Form Strength Ingredient Status TE Flags
207229-001 ACETAMINOPHEN TABLET, EXTENDED RELEASE ACETAMINOPHEN Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 207229.
Type No. Action Status Date Review
Supplement 14 Labeling Approved April 13, 2023 Standard
Supplement 13 Labeling Approved April 13, 2023 Standard
Supplement 10 Labeling Approved April 13, 2023 Standard
Supplement 9 Labeling Approved April 13, 2023 Standard
Original application 1 Approved November 9, 2016 Standard

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260521). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260521 HUMAN OTC DRUG · 20251204 HUMAN OTC DRUG · 20240405 HUMAN OTC DRUG · 20240124

Indications and Usage

openFDA Drug Labeling

USES For Arthritis Pain label • 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 For Muscle Aches & Pain label • temporarily relieves minor aches and pains due to: • muscular aches • backache • minor pain of arthritis • toothache • premenstrual and menstrual cramps • headache • the common cold • temporarily reduces fever

Purpose Pain reliever/fever reducer

Dosage and Administration

openFDA Drug Labeling

DIRECTIONS For Arthritis Pain Label • do not take more than directed (see overdose warning) adults • 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 under 18 years of age • ask a doctor For Muscle Ache and Pain label • do 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 Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 6 geltabs 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 have difficulty swallowing large tablets or capsules. People over 65 may have difficulty swallowing these tablets. 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 the tablet got stuck in your throat 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 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.

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

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. If pregnant or breast-feeding, ask a health professional before use.

Active Ingredient

openFDA Drug Labeling

Drug Facts Active ingredient (in each extended-release tablet) Acetaminophen USP 650 mg

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Acetaminophen Extended-Release 650 mg Tablet NDC 71335-9746-1: 30 Tablets in a BOTTLE NDC 71335-9746-2: 100 Tablets in a BOTTLE NDC 71335-9746-3: 50 Tablets in a BOTTLE NDC 71335-9746-4: 60 Tablets in a BOTTLE NDC 71335-9746-5: 120 Tablets in a BOTTLE NDC 71335-9746-6: 19 Tablets in a BOTTLE NDC 71335-9746-7: 20 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

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
76420-914-01 76420-914 Asclemed USA, Inc. 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-01) January 27, 2025
76420-914-05 76420-914 Asclemed USA, Inc. 50 BOTTLE in 1 CARTON (76420-914-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE January 27, 2025
76420-914-26 76420-914 Asclemed USA, Inc. 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-26) January 25, 2025
76420-914-40 76420-914 Asclemed USA, Inc. 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-40) January 27, 2025
76420-914-42 76420-914 Asclemed USA, Inc. 1 BOTTLE in 1 CARTON (76420-914-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE January 27, 2025
76420-914-60 76420-914 Asclemed USA, Inc. 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (76420-914-60) February 25, 2025
59651-034-15 59651-034 Aurobindo Pharma Limited 1500 TABLET, EXTENDED RELEASE in 1 BAG (59651-034-15) November 9, 2016
59651-034-39 59651-034 Aurobindo Pharma Limited 35000 TABLET, EXTENDED RELEASE in 1 BAG (59651-034-39) November 18, 2022
58602-730-07 58602-730 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-730-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE August 11, 2018
58602-730-14 58602-730 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-730-14) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE August 11, 2018
58602-730-21 58602-730 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-730-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE August 11, 2018
58602-730-28 58602-730 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-730-28) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE December 29, 2021
58602-730-29 58602-730 Aurohealth LLC 150 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-29) August 11, 2018
58602-730-34 58602-730 Aurohealth LLC 200 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-34) August 11, 2018
58602-730-35 58602-730 Aurohealth LLC 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-35) August 11, 2018
58602-730-36 58602-730 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-730-36) / 250 TABLET, EXTENDED RELEASE in 1 BOTTLE November 9, 2016
58602-730-40 58602-730 Aurohealth LLC 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-40) August 11, 2018
58602-730-41 58602-730 Aurohealth LLC 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-41) August 11, 2018
58602-730-44 58602-730 Aurohealth LLC 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-44) January 11, 2021
58602-730-67 58602-730 Aurohealth LLC 290 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-67) August 11, 2018
58602-730-76 58602-730 Aurohealth LLC 325 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-76) August 11, 2018
58602-730-94 58602-730 Aurohealth LLC 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-730-94) April 8, 2020
58602-848-17 58602-848 Aurohealth LLC 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-848-17) May 21, 2026
58602-848-40 58602-848 Aurohealth LLC 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-848-40) May 21, 2026
58602-848-44 58602-848 Aurohealth LLC 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-848-44) May 21, 2026
58602-873-07 58602-873 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-873-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE December 27, 2021
58602-873-14 58602-873 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-873-14) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE December 27, 2021
58602-873-21 58602-873 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-873-21) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE December 27, 2021
58602-873-29 58602-873 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-873-29) / 150 TABLET, EXTENDED RELEASE in 1 BOTTLE December 27, 2021
58602-873-34 58602-873 Aurohealth LLC 200 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-34) December 27, 2021
58602-873-35 58602-873 Aurohealth LLC 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-35) December 27, 2021
58602-873-36 58602-873 Aurohealth LLC 1 BOTTLE in 1 CARTON (58602-873-36) / 250 TABLET, EXTENDED RELEASE in 1 BOTTLE December 27, 2021
58602-873-40 58602-873 Aurohealth LLC 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-40) December 27, 2021
58602-873-41 58602-873 Aurohealth LLC 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-41) December 27, 2021
58602-873-44 58602-873 Aurohealth LLC 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-44) December 27, 2021
58602-873-67 58602-873 Aurohealth LLC 290 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-67) December 27, 2021
58602-873-76 58602-873 Aurohealth LLC 325 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-76) December 27, 2021
58602-873-94 58602-873 Aurohealth LLC 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (58602-873-94) December 27, 2021
21130-108-07 21130-108 Better Living Brands, LLC 1 BOTTLE in 1 CARTON (21130-108-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE June 24, 2022
21130-108-35 21130-108 Better Living Brands, LLC 1 BOTTLE in 1 CARTON (21130-108-35) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE June 24, 2022
37835-512-01 37835-512 Bi-Mart 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (37835-512-01) March 1, 2025
71335-1340-1 71335-1340 Bryant Ranch Prepack 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-1) December 4, 2019
71335-1340-2 71335-1340 Bryant Ranch Prepack 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-2) August 20, 2019
71335-1340-3 71335-1340 Bryant Ranch Prepack 50 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-3) October 7, 2024
71335-1340-4 71335-1340 Bryant Ranch Prepack 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-4) October 7, 2024
71335-1340-5 71335-1340 Bryant Ranch Prepack 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-5) July 23, 2024
71335-1340-6 71335-1340 Bryant Ranch Prepack 19 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-6) October 7, 2024
71335-1340-7 71335-1340 Bryant Ranch Prepack 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1340-7) October 7, 2024
71335-9746-1 71335-9746 Bryant Ranch Prepack 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-1) November 16, 2023
71335-9746-2 71335-9746 Bryant Ranch Prepack 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-2) April 5, 2024
71335-9746-3 71335-9746 Bryant Ranch Prepack 50 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-3) April 5, 2024
71335-9746-4 71335-9746 Bryant Ranch Prepack 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-4) April 5, 2024
71335-9746-5 71335-9746 Bryant Ranch Prepack 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-5) April 5, 2024
71335-9746-6 71335-9746 Bryant Ranch Prepack 19 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-6) April 5, 2024
71335-9746-7 71335-9746 Bryant Ranch Prepack 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-9746-7) April 5, 2024
63868-660-01 63868-660 CHAIN DRUG MARKETING ASSOCIATION INC 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63868-660-01) August 1, 2020
63868-660-50 63868-660 CHAIN DRUG MARKETING ASSOCIATION INC 1 BOTTLE, PLASTIC in 1 PACKAGE (63868-660-50) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC August 1, 2020
69842-930-80 69842-930 CVS Pharmacy 80 TABLET, EXTENDED RELEASE in 1 BOTTLE (69842-930-80) December 21, 2012
69842-037-35 69842-037 CVS Pharmacy, Inc. 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (69842-037-35) December 23, 2020
69842-037-44 69842-037 CVS Pharmacy, Inc. 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (69842-037-44) December 23, 2020
69842-635-07 69842-635 CVS Pharmacy, Inc. 1 BOTTLE in 1 CARTON (69842-635-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE October 13, 2022
57896-268-01 57896-268 GERI-CARE PHARMACEUTICAL CORP 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (57896-268-01) July 1, 2019
62207-183-34 62207-183 Granules India Limited 1 POUCH in 1 BOX (62207-183-34) / 5 TABLET, EXTENDED RELEASE in 1 POUCH June 30, 2019
62207-183-35 62207-183 Granules India Limited 6 POUCH in 1 BOX (62207-183-35) / 3000 TABLET, EXTENDED RELEASE in 1 POUCH May 4, 2024
62207-183-49 62207-183 Granules India Limited 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-183-49) April 18, 2019
62207-183-51 62207-183 Granules India Limited 1 BOTTLE in 1 CARTON (62207-183-51) / 10 TABLET, EXTENDED RELEASE in 1 BOTTLE April 18, 2019
62207-183-87 62207-183 Granules India Limited 1 POUCH in 1 BOX (62207-183-87) / 1 TABLET, EXTENDED RELEASE in 1 POUCH June 30, 2019
62207-183-97 62207-183 Granules India Limited 40000 TABLET, EXTENDED RELEASE in 1 DRUM (62207-183-97) March 25, 2021
62207-188-49 62207-188 Granules India Limited 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-188-49) April 18, 2019
62207-188-51 62207-188 Granules India Limited 1 BOTTLE in 1 CARTON (62207-188-51) / 10 TABLET, EXTENDED RELEASE in 1 BOTTLE April 18, 2019
62207-234-35 62207-234 Granules India Limited 18000 TABLET, EXTENDED RELEASE in 1 BOX (62207-234-35) January 1, 2025
62207-892-49 62207-892 Granules India Limited 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-892-49) April 16, 2026
62207-892-51 62207-892 Granules India Limited 1 BOTTLE in 1 CARTON (62207-892-51) / 10 TABLET, EXTENDED RELEASE in 1 BOTTLE April 16, 2026
70010-160-01 70010-160 Granules Pharmaceuticals Inc. 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-160-01) February 15, 2022
30142-157-07 30142-157 KROGER COMPANY 1 BOTTLE in 1 CARTON (30142-157-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE May 25, 2021
30142-157-35 30142-157 KROGER COMPANY 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (30142-157-35) May 25, 2021
0615-8624-39 0615-8624 NCS HealthCare of KY, LLC dba Vangard Labs 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-8624-39) February 10, 2026
49483-699-01 49483-699 TIME CAP LABORATORIES, INC. 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-01) October 4, 2021
49483-699-05 49483-699 TIME CAP LABORATORIES, INC. 50 BOTTLE in 1 CARTON (49483-699-05) / 1 TABLET, EXTENDED RELEASE in 1 BOTTLE October 4, 2021
49483-699-26 49483-699 TIME CAP LABORATORIES, INC. 225 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-26) November 7, 2022
49483-699-40 49483-699 TIME CAP LABORATORIES, INC. 400 TABLET, EXTENDED RELEASE in 1 BOTTLE (49483-699-40) October 4, 2021
49483-699-42 49483-699 TIME CAP LABORATORIES, INC. 1 BOTTLE in 1 CARTON (49483-699-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE November 7, 2022
0363-9604-07 0363-9604 WALGREEN CO. 1 BOTTLE in 1 CARTON (0363-9604-07) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE July 7, 2021
0363-9604-35 0363-9604 WALGREEN CO. 1 BOTTLE in 1 CARTON (0363-9604-35) / 225 TABLET, EXTENDED RELEASE in 1 BOTTLE July 7, 2021
79903-132-25 79903-132 WALMART INC. 325 TABLET, EXTENDED RELEASE in 1 BOTTLE (79903-132-25) July 26, 2022
0363-0340-08 0363-0340 Walgreen Company 80 TABLET, EXTENDED RELEASE in 1 BOTTLE (0363-0340-08) May 1, 2016
76420-914 76420-914 Asclemed USA, Inc. — October 4, 2021
59651-034 59651-034 Aurobindo Pharma Limited — November 9, 2016
58602-730 58602-730 Aurohealth LLC — November 9, 2016
58602-848 58602-848 Aurohealth LLC — May 16, 2020
58602-873 58602-873 Aurohealth LLC — December 27, 2021
21130-108 21130-108 Better Living Brands, LLC — June 24, 2022
37835-512 37835-512 Bi-Mart — April 18, 2019
71335-1340 71335-1340 Bryant Ranch Prepack — July 1, 2019
71335-9746 71335-9746 Bryant Ranch Prepack — October 4, 2021
63868-660 63868-660 CHAIN DRUG MARKETING ASSOCIATION INC — August 1, 2020
69842-930 69842-930 CVS Pharmacy — December 21, 2012
69842-037 69842-037 CVS Pharmacy, Inc. — December 23, 2020
69842-635 69842-635 CVS Pharmacy, Inc. — October 13, 2022
57896-268 57896-268 GERI-CARE PHARMACEUTICAL CORP — July 1, 2019
62207-183 62207-183 Granules India Limited — April 18, 2019
62207-188 62207-188 Granules India Limited — April 18, 2019
62207-234 62207-234 Granules India Limited — January 1, 2025
62207-892 62207-892 Granules India Limited — April 16, 2026
70010-160 70010-160 Granules Pharmaceuticals Inc. — February 15, 2022
30142-157 30142-157 KROGER COMPANY — May 25, 2021
0615-8624 0615-8624 NCS HealthCare of KY, LLC dba Vangard Labs — February 15, 2022
49483-699 49483-699 TIME CAP LABORATORIES, INC. — October 4, 2021
0363-9604 0363-9604 WALGREEN CO. — July 7, 2021
79903-132 79903-132 WALMART INC. — July 26, 2022
0363-0340 0363-0340 Walgreen Company — May 1, 2016

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.