Acetaminophen

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2023-06-07
Label type
Human OTC Drug Label
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:30:24

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure11 sections

Indications and 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

Dosage and administration

do not take more than directed (see overdose warning). Adults: 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. Under 18 years of age: ask a doctor

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).  USP Dissolution test is pending 

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:
    • minor pain of arthritis
    • muscular aches
    • backache
    • premenstrual and menstrual cramps
    • the common cold
    • headache
    • toothache
  • 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:

  • 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.

Under 18 years of age:

  • ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20o to 25oC (68o to 77oF). Avoid excessive heat 40oC (104oF). 
  • USP Dissolution test is pending 

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 (500 Tablet Bottle)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 58602-866-40         PrimaryHealth

TO OPEN: 1. PUSH DOWN
                    2. TURN CAP

COMPARE TO Tylenol®
8 HR Arthritis Pain
Active Ingredient*

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN


8 HOUR    ARTHRITIS PAIN


Acetaminophen
Extended-Release Tablets USP

650 mg

Pain Reliever/Fever Reducer
For the Temporary Relief of
Minor Arthritis Pain

500 Extended-
release tablets
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (500 Tablet Bottle)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 650 mg (500 Tablet Bottle)
          



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
58602-86658602-866-40

Ingredients#

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

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

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 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-10-28 04:53 UTC2022-10A207229-001ACETAMINOPHEN650MGTABLET, EXTENDED RELEASE / ORAL2016-11-09f41ea6bd6efb…

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
fb7868aa-1279-4e6a-9ab8-fd16a2d754a753e7813e-e621-4166-b5c9-72cca45cd4f32024-01-18WarningsExact identifier
spl set id: 53e7813e-e621-4166-b5c9-72cca45cd4f3

Reported adverse events (FAERS/openFDA)#

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