Acetaminophen

Acetaminophen
SPL v1
SPL
SPL Set ID 88e5345a-f240-473c-b329-2b0aa5f081f9
Route
ORAL
Published
Effective Date 2025-08-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg)
Inactive Ingredients
Starch, Corn Titanium Dioxide Triacetin Silicon Dioxide Povidone, Unspecified Hydroxyethyl Cellulose (140 Mpa.s At 5%) Microcrystalline Cellulose Sodium Starch Glycolate Type B Potato Hypromellose, Unspecified Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: I;06 Shape: capsule Color: white Size: 19 mm Score: 1
Marketing Status
ANDA Active Since 2026-02-01

Description

Drug Facts

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

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
Section 42229-5

Drug Facts

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.

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
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

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

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

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

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.

Principal Display Panel – Carton – 650 Mg

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

Acetaminophen

Extended-Release

Tablet USP

Pain Reliever/

Fever Reducer

650 mg

Active Ingredient (in Each Extended Release Tablet)

Acetaminophen USP 650 mg


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Purpose

Pain reliever/fever reducer

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.

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
Do Not Use (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

Other Information (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 (Inactive ingredients)

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

Packaging Information (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

Questions Or Comments? (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

Stop Use and Ask A Doctor If (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. (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.

Principal Display Panel – Carton – 650 Mg (Principal Display Panel – Carton – 650 mg)

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 (Principal Display Panel – Blister – 650 mg)

Acetaminophen

Extended-Release

Tablet USP

Pain Reliever/

Fever Reducer

650 mg

Active Ingredient (in Each Extended Release Tablet) (Active Ingredient (in each extended release tablet))

Acetaminophen USP 650 mg


Advanced Ingredient Data


Raw Label Data

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