Acetaminophen Extended-release Tablets, Usp 650mg

Acetaminophen Extended-release Tablets, Usp 650mg
SPL v3
SPL
SPL Set ID c065c531-88f5-0930-e053-2a95a90ae861
Route
ORAL
Published
Effective Date 2021-04-26
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 2021-04-30

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

Questions Or Comments?

call 1-855-274-4122

Manufactured by:

Aurobindo Pharma Limited

Unit-VII (SEZ), Mahabubnagar (Dt)-509302, India.

For BluePoint Laboratories

Rev: 03/2021

M.L. No.: 22/MN/AP/2009/F/R

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.

Package Label Principal Display Panel

Acetaminophen Extended-Release tablets USP 650mg (100 tablets Carton) NDC: 68001-495-00

Acetaminophen Extended-Release tablets USP 650mg (100 tablets Container Label) NDC: 68001-495-00

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

Questions Or Comments? (Questions or comments?)

call 1-855-274-4122

Manufactured by:

Aurobindo Pharma Limited

Unit-VII (SEZ), Mahabubnagar (Dt)-509302, India.

For BluePoint Laboratories

Rev: 03/2021

M.L. No.: 22/MN/AP/2009/F/R

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.

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Acetaminophen Extended-Release tablets USP 650mg (100 tablets Carton) NDC: 68001-495-00

Acetaminophen Extended-Release tablets USP 650mg (100 tablets Container Label) NDC: 68001-495-00

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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