0752-cardinal

SPL v7

SPL

SPL Set ID 7be4d67e-1af9-f059-e053-2991aa0a382e

Route

ORAL

Published

Effective Date 2026-02-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Talc Titanium Dioxide Stearic Acid Light Mineral Oil D&c Yellow No. 10 Magnesium Stearate Triacetin Fd&c Blue No. 1 Croscarmellose Povidone K30 Starch, Corn Silicon Dioxide Hypromelloses Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

Imprint: CPC752 Shape: oval Color: blue Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2018-11-29

Description

Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 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 ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Section 34088-5

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.

Section 42229-5

*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® PM Extra Strength.

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

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

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

© 2025 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

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

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Section 50567-7

When using this product

avoid alcoholic beverages
do not drive a motor vehicle or operate machinery
drowsiness will occur

Section 50568-5

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

liver disease
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma

Section 50570-1

Do not use

with any other product containing diphenhydramine, even one used on skin
in children under 12 years of age
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 have ever had an allergic reaction to this product or any of its ingredients

Section 51727-6

croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

Section 51945-4

LEADER _TM

NDC 70000-0411-3

Extra Strength Acetaminophen PM

Acetaminophen, 500 mg

Diphenhydramine HCl, 25 mg

Pain Reliever/Nighttime Sleep-Aid

COMPARE TO TYLENOL ^® PM EXTRA STRENGTH active ingredients*

100 CAPLETS

Section 53414-9

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

Section 55105-1

Purposes

Pain reliever

Nighttime sleep-aid

Directions

do not take more than directed (see overdose warning)
adults and children 12 years of age and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
children under 12 years: do not use

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Other Information

store in a dry place at 15°-30°C (59°-86°F).
see end flap for expiration date and lot number.

Questions Or Comments?

1-800-231-4670

Structured Label Content

Uses

temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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 Kenvue Inc., owner of the registered trademark Tylenol® PM Extra Strength.

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

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

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

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

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 10 days
fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product

avoid alcoholic beverages
do not drive a motor vehicle or operate machinery
drowsiness will occur

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

liver disease
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland
glaucoma

Section 50570-1 (50570-1)

Do not use

with any other product containing diphenhydramine, even one used on skin
in children under 12 years of age
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 have ever had an allergic reaction to this product or any of its ingredients

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

LEADER _TM

NDC 70000-0411-3

Extra Strength Acetaminophen PM

Acetaminophen, 500 mg

Diphenhydramine HCl, 25 mg

Pain Reliever/Nighttime Sleep-Aid

COMPARE TO TYLENOL ^® PM EXTRA STRENGTH active ingredients*

100 CAPLETS

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purposes

Pain reliever

Nighttime sleep-aid

Directions

do not take more than directed (see overdose warning)
adults and children 12 years of age and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours.
children under 12 years: do not use

Drug Facts

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Other Information (Other information)

store in a dry place at 15°-30°C (59°-86°F).
see end flap for expiration date and lot number.

Questions Or Comments? (Questions or comments?)

1-800-231-4670

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness", "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 (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.", "42229-5": "*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Tylenol® PM Extra Strength. TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 © 2025 Cardinal Health. All Rights Reserved. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners. 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 sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. new symptoms occur redness or swelling is present pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days These could be signs of a serious condition.", "50567-7": "When using this product avoid alcoholic beverages do not drive a motor vehicle or operate machinery drowsiness will occur", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers", "50569-3": "Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma", "50570-1": "Do not use with any other product containing diphenhydramine, even one used on skin in children under 12 years of age 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 have ever had an allergic reaction to this product or any of its ingredients", "51727-6": "croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, mineral oil, polyvinylpyrrolidone, pregelatinized starch, silica, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin", "51945-4": "LEADER TM NDC 70000-0411-3 Extra Strength Acetaminophen PM Acetaminophen, 500 mg Diphenhydramine HCl, 25 mg Pain Reliever/Nighttime Sleep-Aid COMPARE TO TYLENOL ® PM EXTRA STRENGTH active ingredients* 100 CAPLETS", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purposes Pain reliever Nighttime sleep-aid", "Directions": "do not take more than directed (see overdose warning) adults and children 12 years of age and over: take 2 caplets at bedtime. Do not take more than 2 caplets of this product in 24 hours. children under 12 years: do not use", "Drug Facts": "Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg", "Other information": "store in a dry place at 15°-30°C (59°-86°F). see end flap for expiration date and lot number.", "Questions or comments?": "1-800-231-4670"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:31.532422 · Updated: 2026-03-14T23:13:58.834798