5427-cardinal

SPL v8

SPL

SPL Set ID 7c342ae6-5de6-5c2f-e053-2a91aa0a3f0d

Route

ORAL

Published

Effective Date 2024-12-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg)

Inactive Ingredients

Sodium Starch Glycolate Type A Potato Stearic Acid Starch, Corn Povidone K30

Identifiers & Packaging

Pill Appearance

Imprint: 54;27 Shape: round Color: white Size: 12 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-05-28

Description

Active ingredient Acetaminophen 500 mg

Medication Information

Warnings and Precautions

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: ● skin reddening ● blisters ● rash

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

Description

Active ingredient Acetaminophen 500 mg

Uses

Temporarily reduces fever and relieves minor aches and pains due to:

● headache

● muscular aches

● common cold

● toothache

● backache

● minor pain of arthritis

● premenstrual and menstrual cramps

Section 34088-5

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.

Section 42229-5

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Extra Strength.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

100% Money Back Guarantee

Return to place of purchase if not satisfied.

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50568-5

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if you have liver disease

Section 50570-1

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

Section 51727-6

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Section 51945-4

LEADER _TM

NDC 70000-0410-2

Extra Strength Acetaminophen

Tablets, 500 mg

Pain Reliever/ Fever Reducer

For Adults

Compare to Tylenol ^® Extra Strength active ingredient*

100 Tablets

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Pain Reliever/ Fever Reducer

Directions

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

adults and children 12 years and over:

● take 2 tablets every 6 hours while symptoms last

● do not take more than 6 tablets 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

Drug Facts

Active ingredient

Acetaminophen 500 mg

Other Information

store at room temperature

Questions Or Comments?

Call (800) 231-4670

Structured Label Content

Uses

Temporarily reduces fever and relieves minor aches and pains due to:

● headache

● muscular aches

● common cold

● toothache

● backache

● minor pain of arthritis

● premenstrual and menstrual cramps

Warnings and Precautions (34071-1)

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: ● skin reddening ● blisters ● rash

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

Section 34088-5 (34088-5)

Section 42229-5 (42229-5)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Extra Strength.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

100% Money Back Guarantee

Return to place of purchase if not satisfied.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver disease

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Section 51945-4 (51945-4)

LEADER _TM

NDC 70000-0410-2

Extra Strength Acetaminophen

Tablets, 500 mg

Pain Reliever/ Fever Reducer

For Adults

Compare to Tylenol ^® Extra Strength active ingredient*

100 Tablets

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Pain Reliever/ Fever Reducer

Directions

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

adults and children 12 years and over:

● take 2 tablets every 6 hours while symptoms last

● do not take more than 6 tablets 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

Drug Facts

Active ingredient

Acetaminophen 500 mg

Other Information

store at room temperature

Questions Or Comments? (Questions or comments?)

Call (800) 231-4670

Advanced Ingredient Data

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

Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily reduces fever and relieves minor aches and pains due to: ● headache ● muscular aches ● common cold ● toothache ● backache ● minor pain of arthritis ● premenstrual and menstrual cramps", "34071-1": "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: ● skin reddening ● blisters ● rash If a skin reaction occurs, stop use and seek medical help right away.", "34088-5": "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.", "42229-5": "*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® Extra Strength. DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 100% Money Back Guarantee Return to place of purchase if not satisfied.", "50565-1": "Keep out of reach of children.", "50566-9": "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.", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin", "50569-3": "Ask a doctor before use if you have liver disease", "50570-1": "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", "51727-6": "Povidone, pregelatinized starch, sodium starch glycolate, stearic acid", "51945-4": "LEADER TM NDC 70000-0410-2 Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/ Fever Reducer For Adults Compare to Tylenol ® Extra Strength active ingredient* 100 Tablets", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Pain Reliever/ Fever Reducer", "Directions": "● do not take more than directed (see overdose warning) adults and children 12 years and over: ● take 2 tablets every 6 hours while symptoms last ● do not take more than 6 tablets 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", "Drug Facts": "Active ingredient Acetaminophen 500 mg", "Other Information": "store at room temperature", "Questions or comments?": "Call (800) 231-4670"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:23.953754 · Updated: 2026-03-14T23:07:07.673818