Acetaminophen Extended Release Tablets 650 Mg

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (650 mg)

Inactive Ingredients

Hydroxyethyl Cellulose (140 Mpa.s At 5%) Hypromellose 2910 (6 Mpa.s) Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 400 Povidone K30 Starch, Corn Sodium Starch Glycolate Type A Corn Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: G650 Shape: capsule Color: white Size: 19 mm Score: 1

Marketing Status

ANDA Active Since 2019-04-18

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 650 mg

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 caplets in 24 hours, which is the maximum daily amount

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks everyday 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 caplets every 8 hours with water • swallow whole; do not crush, chew, split or dissolve • do not take more than 6 caplets 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 drugs 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.

Questions ?

call toll free 1-844-912-4012

Other Information

• store between 20-25°C (68-77°F)

• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Inactive Ingredients

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Principal Display Panel

NDC 37835-512-01

Compare to the active ingredients in Tylenol ^®8 HR Arthritis Pain*

Acetaminophen Extended-release Tablets

650 mg

Pain reliever/fever reducer

For the Temporary Relief of Minor Arthritis Pain

100 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Tylenol ^® 8 HR Arthritis Pain.

Distributed by:

BI-MART

Eugene, OR 97402

Stop Use and Ask 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 (1-800 222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Caplet)

Acetaminophen 650 mg

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.

Structured Label Content

Uses (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

Purpose (PURPOSE)

Pain reliever/fever reducer

Warnings (WARNINGS)

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

• more than 6 caplets in 24 hours, which is the maximum daily amount

• with other drugs containing acetaminophen

• 3 or more alcoholic drinks everyday 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 (DIRECTIONS)

• do not take more than directed (see overdose warning)

adults	• take 2 caplets every 8 hours with water • swallow whole; do not crush, chew, split or dissolve • do not take more than 6 caplets 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 drugs 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.

Questions ? (QUESTIONS ?)

call toll free 1-844-912-4012

Other Information (OTHER INFORMATION)

• store between 20-25°C (68-77°F)

• DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Inactive Ingredients (INACTIVE INGREDIENTS)

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 37835-512-01

Compare to the active ingredients in Tylenol ^®8 HR Arthritis Pain*

Acetaminophen Extended-release Tablets

650 mg

Pain reliever/fever reducer

For the Temporary Relief of Minor Arthritis Pain

100 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Tylenol ^® 8 HR Arthritis Pain.

Distributed by:

BI-MART

Eugene, OR 97402

Stop Use and Ask Doctor If (Stop use and ask 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 (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 (1-800 222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each Caplet) (ACTIVE INGREDIENT (IN EACH CAPLET))

Acetaminophen 650 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease.

Ask A Doctor Or Pharmacist Before Use if You Are (Ask a doctor or pharmacist before use if you are )

taking the blood thinning drug warfarin.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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", "PURPOSE": "Pain reliever/fever reducer", "WARNINGS": "Liver warning: This product contains acetaminophen. Severe Liver damage may occur if you take • more than 6 caplets in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen • 3 or more alcoholic drinks everyday 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 caplets every 8 hours with water • swallow whole; do not crush, chew, split or dissolve • do not take more than 6 caplets 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 drugs 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.", "QUESTIONS ?": "call toll free 1-844-912-4012", "OTHER INFORMATION": "• store between 20-25°C (68-77°F) • DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.", "INACTIVE INGREDIENTS": "hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid", "PRINCIPAL DISPLAY PANEL": "NDC 37835-512-01 Compare to the active ingredients in Tylenol ® 8 HR Arthritis Pain* Acetaminophen Extended-release Tablets 650 mg Pain reliever/fever reducer For the Temporary Relief of Minor Arthritis Pain 100 Caplets *This product is not manufactured or distributed by the owner of the registered trademark Tylenol ® 8 HR Arthritis Pain. Distributed by: BI-MART Eugene, OR 97402", "Stop use and ask 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 (1-800 222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "ACTIVE INGREDIENT (IN EACH CAPLET)": "Acetaminophen 650 mg", "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."}

Acetaminophen Extended Release Tablets 650 Mg

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information