Acetaminophen Tablets 500 Mg

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Povidone K30 Starch, Corn Stearic Acid Sodium Starch Glycolate Type A Potato Hypromellose, Unspecified Polyethylene Glycol 400

Identifiers & Packaging

Pill Appearance

Imprint: G551 Shape: capsule Color: white Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-02-15

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen, USP 500 mg

Uses

• temporarily relieves minor aches and pains due to:

• the common cold

• headache

• backache

• minor pain of arthritis

• toothache

• muscular aches

• premenstrual and menstrual cramps

• temporarily reduces fever

Warnings

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

• more than 4,000 mg of acetaminophen 24 hours.

• 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 and children 12 years and over	• take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years	• 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 other inactive ingredients in this product.

Other Information

• store at 20-25°C (68-77°F). See USP Controlled Room Temparature

• avoid high humidity

• See end panel for lot number and expiration date

Inactive Ingredients

hydroxyethyl methyl cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Principal Display Panel

Questions Or Comments ?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

+All trademarkes are property of their reapective owners.

This product is not affliated with the makers/owners of

Extra Strength Tylenol ^®Caplets.

Distributed by:

Granules Pharmaceuticals INc.,

Chantilly, VA 20151

MADE IN INDIA

Rev.08/21

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

Over dose warning: In case of overdose, get medical help or Contact 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.

Active Ingredient (in Each Caplet)

Acetaminophen, USP 500 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:

• the common cold

• headache

• backache

• minor pain of arthritis

• toothache

• muscular aches

• premenstrual and menstrual cramps

• 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 4,000 mg of acetaminophen 24 hours.

• 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 and children 12 years and over	• take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years	• 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 other inactive ingredients in this product.

Other Information (OTHER INFORMATION)

• store at 20-25°C (68-77°F). See USP Controlled Room Temparature

• avoid high humidity

• See end panel for lot number and expiration date

Inactive Ingredients (INACTIVE INGREDIENTS)

hydroxyethyl methyl cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Questions Or Comments ? (QUESTIONS OR COMMENTS ?)

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

+All trademarkes are property of their reapective owners.

This product is not affliated with the makers/owners of

Extra Strength Tylenol ^®Caplets.

Distributed by:

Granules Pharmaceuticals INc.,

Chantilly, VA 20151

MADE IN INDIA

Rev.08/21

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)

Over dose warning: In case of overdose, get medical help or Contact 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.

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

Acetaminophen, USP 500 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

[{"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"USES": "• temporarily relieves minor aches and pains due to: • the common cold • headache • backache • minor pain of arthritis • toothache • muscular aches • premenstrual and menstrual cramps • 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 4,000 mg of acetaminophen 24 hours. • 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 and children 12 years and over • take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor children under 12 years • 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 other inactive ingredients in this product.", "OTHER INFORMATION": "• store at 20-25°C (68-77°F). See USP Controlled Room Temparature • avoid high humidity • See end panel for lot number and expiration date", "INACTIVE INGREDIENTS": "hydroxyethyl methyl cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.", "QUESTIONS OR COMMENTS ?": "Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST. +All trademarkes are property of their reapective owners. This product is not affliated with the makers/owners of Extra Strength Tylenol ® Caplets. Distributed by: Granules Pharmaceuticals INc., Chantilly, VA 20151 MADE IN INDIA Rev.08/21", "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": "Over dose warning: In case of overdose, get medical help or Contact 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.", "ACTIVE INGREDIENT (IN EACH CAPLET)": "Acetaminophen, USP 500 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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information