Pain Reliever

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Castor Oil Hypromellose, Unspecified Povidone, Unspecified Sodium Starch Glycolate Type A Potato Starch, Corn Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: 44;175 Shape: oval Color: white Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-11-14

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg

Uses

temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- the common cold
- backache
- toothache
- minor pain from arthritis
- 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 in 24 hours
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:

rash
skin reddening
blisters

If a skin reaction occurs, stop use and seek medical help right away.

Directions

do not take more than directed
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 take for more than 10 days unless directed by a doctor
children under 12 years: 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.

Other Information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive Ingredients

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions Or Comments?

1-800-426-9391

Principal Display Panel

COMPARE TO EXTRA STRENGTH

TYLENOL® CAPLETS ACTIVE INGREDIENT*

M

Member's

Mark_™

NDC 68196-031-06

EXTRA STRENGTH

Acetaminophen

500 mg CAPLETS

Pain Reliever/Fever Reducer

600 CAPLETS**

(**CAPSULE SHAPED TABLETS)

ACTUAL SIZE

FOR ADULTS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Kenvue Inc., owner of the registered

trademark Extra Strength Tylenol® Caplets. 50844 ORG102417578

DISTRIBUTED BY: SAM'S WEST, INC., BENTONVILLE, AR 72716

members mark 44-175

Stop Use and Ask A Doctor If

redness or swelling is present
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
any new symptoms appear

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 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

temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- the common cold
- backache
- toothache
- minor pain from arthritis
- 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 in 24 hours
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:

rash
skin reddening
blisters

If a skin reaction occurs, stop use and seek medical help right away.

Directions

do not take more than directed
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 take 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 drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Other Information (Other information)

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Inactive Ingredients (Inactive ingredients)

castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid

Questions Or Comments? (Questions or comments?)

1-800-426-9391

Principal Display Panel

COMPARE TO EXTRA STRENGTH

TYLENOL® CAPLETS ACTIVE INGREDIENT*

M

Member's

Mark_™

NDC 68196-031-06

EXTRA STRENGTH

Acetaminophen

500 mg CAPLETS

Pain Reliever/Fever Reducer

600 CAPLETS**

(**CAPSULE SHAPED TABLETS)

ACTUAL SIZE

FOR ADULTS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED

SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by Kenvue Inc., owner of the registered

trademark Extra Strength Tylenol® Caplets. 50844 ORG102417578

DISTRIBUTED BY: SAM'S WEST, INC., BENTONVILLE, AR 72716

members mark 44-175

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

redness or swelling is present
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days
any new symptoms appear

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.)

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 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": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CASTOR OIL", "unii": "D5340Y2I9G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "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": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: headache muscular aches the common cold backache toothache minor pain from arthritis 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 in 24 hours 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: rash skin reddening blisters If a skin reaction occurs, stop use and seek medical help right away.", "Directions": "do not take more than directed 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 take for more than 10 days unless directed by a doctor children under 12 years: 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.", "Other information": "store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package", "Inactive ingredients": "castor oil, hypromellose, povidone, sodium starch glycolate, starch, stearic acid", "Questions or comments?": "1-800-426-9391", "Principal Display Panel": "COMPARE TO EXTRA STRENGTH TYLENOL® CAPLETS ACTIVE INGREDIENT* M Member's Mark ™ NDC 68196-031-06 EXTRA STRENGTH Acetaminophen 500 mg CAPLETS Pain Reliever/Fever Reducer 600 CAPLETS** (**CAPSULE SHAPED TABLETS) ACTUAL SIZE FOR ADULTS TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Extra Strength Tylenol® Caplets. 50844 ORG102417578 DISTRIBUTED BY: SAM'S WEST, INC., BENTONVILLE, AR 72716 members mark 44-175", "Stop use and ask a doctor if": "redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days any new symptoms appear", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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 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