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Acetaminophen

Dosage form
TABLET
Labeler
American Health Packaging
Label updated
2026-02-04
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN
View original label and images on DailyMed ↗
Label information

Drug Facts

Active Ingredient (in each extended release tablet)

Acetaminophen USP 650 mg

Purpose

Pain reliever/fever reducer

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
Warnings

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
  • 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 ue 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 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
  • 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
  • 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
  • USP Dissolution test is pending
Inactive ingredients

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

Questions or comments?
  • about the drug product, call Aurobindo Pharma USA at 1-855-274-4122
  • about the packaging or labeling, call American Health Packaging at 1-800-707-4621

Contains No Aspirin

PACKAGING INFORMATION

American Health Packaging unit dose blisters contain drug product from BluePoint Laboratories as follows:
(650 mg / 30 UD) NDC 60687-924-21 packaged from NDC 68001-495

Distributed by:
American Health Packaging
Columbus, OH 43217

8492421/0825F

Principal Display Panel – Carton – 650 mg

[Image in the official label — see DailyMed source]

NDC 60687- 924-21

Acetaminophen
Extended-releaseTablets USP
Pain Reliever/Fever Reducer

650 mg

30 Tablets (3 x 10)

DO NOT USE WITH OTHER MEDICINES
CONTAINING ACETAMINOPHEN.

Drug Facts

Active Ingredient               Purpose
(in each caplet)

Acetaminophen USP, 650 mg.................Pain reliever/fever reducer

Uses
See package insert for complete Drug Facts information.

Warnings
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.

See package insert for additional Drug Facts warnings.

Directions
• do not take more than directed, see package insert for overdose warning
and complete Drug Facts information.

Other Information • store at 20° to 25°C (68° to 77°F). Avoid excessive
heat 40°C (104°F). • FOR YOUR PROTECTION: Do not use product if
blister is torn or broken.
•USP Dissolution test is pending

Contains No Aspirin

The drug product contained in this package is from
NDC # 68001-495, BluePoint Laboratories

Distributed by: American Health Packaging
Columbus, OH 43217

792421
0492421/0825

Principal Display Panel – Blister – 650 mg

[Image in the official label — see DailyMed source]

Acetaminophen
Extended-Release
Tablet USP
Pain Reliever/
Fever Reducer

650 mg

DailyMed Set ID: 88e5345a-f240-473c-b329-2b0aa5f081f9 · Version 1
NDC: 60687-924