FDA.reportPublic FDA data

Acetaminophen

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2024-01-24
Label type
Human OTC Drug Label
Version
4
Source
full-release
Hydrated at
2026-06-01 00:07:57

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure12 sections

Indications and uses

temporarily relieves minor aches and pains due to: muscular aches backache minor pain of arthritis toothache premenstrual and menstrual cramp headache the common cold temporarily reduces fever

Dosage and administration

  do not take more than directed (see overdose warning). adults and children 12 years and over take 2 tablets every 8 hours with water swallow whole; do not crush, chew, split or dissolve do not take more than 6 tablets in 24 hours do not use for more than 10 days unless directed by a doctor. children under 12 years do not use

Storage and handling

store at 20 o to 25 o C (68 o to 77 o F). Avoid excessive heat 40 o C (104 o F).  do not use if carton is opened or foil inner seal is broken Meets USP dissolution test 3 

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each extended-release tablet)

Acetaminophen USP 650 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
    • muscular aches
    • backache
    • minor pain of arthritis
    • toothache
    • premenstrual and menstrual cramp
    • headache
    • the common cold
  • temporarily reduces fever

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 6 tablets 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

OTC - DO NOT USE SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

 

  • do not take more than directed (see overdose warning).
adults and children 12 years and over
  • take 2 tablets every 8 hours with water
  • swallow whole; do not crush, chew, split or dissolve
  • do not take more than 6 tablets in 24 hours
  • do not use for more than 10 days unless directed by a doctor.
children under 12 years
  • do not use

Other information

STORAGE AND HANDLING SECTION

  • store at 20o to 25oC (68o to 77oF). Avoid excessive heat 40oC (104oF). 
  • do not use if carton is opened or foil inner seal is broken
  • Meets USP dissolution test 3 

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize), sodium starch glycolate, titanium dioxide, triacetin

Questions or comments? 
  call 1-855-274-4122
Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code: TS/DRUGS/22/2009

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablet Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH
TO OPEN: 1. PUSH DOWN         NDC 58602-873-36
                    2. TURN CAP
DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN
8 HOUR    MUSCLE ACHES & PAIN
Acetaminophen
Extended-Release
Tablets USP
650 mg
Pain Reliever/Fever Reducer
For up to 8 Hours Relief of
Minor Muscle Aches & Pain
250 Extended-release tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablet Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablet Bottle)          



PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablets Container Carton)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AUROHEALTH
NDC 58602-873-36

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN

8 HOUR             MUSCLE ACHES & PAIN

Acetaminophen
Extended-Release
Tablets USP
650 mg
Pain Reliever/Fever Reducer
For Up to 8 Hours Relief of
Minor Muscle Aches & Pain
250 Extended-release tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablets Container Carton)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (250 Tablets Container Carton)


DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN4
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD4
11483998 HR APAP 650 MG Extended Release Oral TabletSY4
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-873-07Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE14
58602-873-07Acetaminophen24 in 1 BOTTLETABLET, EXTENDED RELEASE244
58602-873-14Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE14
58602-873-14Acetaminophen50 in 1 BOTTLETABLET, EXTENDED RELEASE504
58602-873-21Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE14
58602-873-21Acetaminophen100 in 1 BOTTLETABLET, EXTENDED RELEASE1004
58602-873-29Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE14
58602-873-29Acetaminophen150 in 1 BOTTLETABLET, EXTENDED RELEASE1504
58602-873-34Acetaminophen200 in 1 BOTTLETABLET, EXTENDED RELEASE2004
58602-873-35Acetaminophen225 in 1 BOTTLETABLET, EXTENDED RELEASE2254
58602-873-36Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE14
58602-873-36Acetaminophen250 in 1 BOTTLETABLET, EXTENDED RELEASE2504
58602-873-40Acetaminophen500 in 1 BOTTLETABLET, EXTENDED RELEASE5004
58602-873-41Acetaminophen1000 in 1 BOTTLETABLET, EXTENDED RELEASE10004
58602-873-44Acetaminophen400 in 1 BOTTLETABLET, EXTENDED RELEASE4004
58602-873-67Acetaminophen290 in 1 BOTTLETABLET, EXTENDED RELEASE2904
58602-873-76Acetaminophen325 in 1 BOTTLETABLET, EXTENDED RELEASE3254
58602-873-94Acetaminophen100 in 1 BOTTLETABLET, EXTENDED RELEASE1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-873ACETAMINOPHEN TABLET, EXTENDED RELEASE [AUROHEALTH LLC]4Current NDC, Legacy NDC, 18 package rows20240126_f076fd33-9eaf-49b9-b0ee-6a349567c5ff.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-87358602-873-36, 58602-873-07, 58602-873-14, 58602-873-21, 58602-873-29, 58602-873-34, 58602-873-35, 58602-873-67, 58602-873-76, 58602-873-40, 58602-873-41, 58602-873-94, 58602-873-44

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE B POTATO27NA468985IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207229-001ACETAMINOPHENACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09c2088c7a36db…
2026-09-14 22:38:342026-08A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-0984e616aacf4f…
2026-08-18 06:07:402026-07A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-0987673890dc5c…
2021-03-12 10:30 UTC2021-03A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-093f01610625f2…
2019-09-15 20:21 UTC2019-09A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09b00525d2431f…
2019-07-19 19:46 UTC2019-07A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-093f0d92c62455…
2023-05-13 08:27 UTC2023-05A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09053a50430f4f…
2023-01-26 05:58 UTC2023-01A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-093a93d1ddd44b…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENAurohealth LLCf076fd33-9eaf-49b9-b0ee-6a349567c5ff2024-01-24WarningsExact identifier
ndc (package): 58602-873-35
ndc (package): 58602-873-07
ndc (package): 58602-873-36
ndc (package): 58602-873-67
ndc (package): 58602-873-44
ndc (package): 58602-873-94
ndc (package): 58602-873-41
ndc (package): 58602-873-76
ndc (package): 58602-873-34
ndc (package): 58602-873-21
ndc (package): 58602-873-29
ndc (package): 58602-873-14
ndc (package): 58602-873-40
ndc (product): 58602-873
ndc11 (package): 58602087335
ndc11 (package): 58602087307
ndc11 (package): 58602087321
ndc11 (package): 58602087394
ndc11 (package): 58602087336
ndc11 (package): 58602087340
ndc11 (package): 58602087367
ndc11 (package): 58602087341
ndc11 (package): 58602087344
ndc11 (package): 58602087334
ndc11 (package): 58602087376
ndc11 (package): 58602087314
ndc11 (package): 58602087329
spl id: 144490f4-f2a5-4c6d-abf2-5e7ee65d66d7
spl set id: f076fd33-9eaf-49b9-b0ee-6a349567c5ff

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.