meijer®

meijer®
SPL v2
SPL
SPL Set ID 376fed3b-7625-6379-e063-6394a90a188d
Route
oral
Published
Effective Date 2025-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg) diphenhydramine (25 mg)
Inactive Ingredients
fd&c blue no. 1 fd&c blue no. 2 hypromellose, unspecified magnesium stearate microcrystalline cellulose polyethylene glycol 400 povidone k30 starch, corn stearic acid titanium dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-08-05

Purpose

Pain reliever Nighttime sleep aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg


Medication Information

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:

• skin reddening  • blisters  • rash

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

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.

• with any other product containing diphenhydramine, even one used on skin

• in children under 12 years of age

• if you have ever had an allergic reaction to this product or any of its ingredients

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

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers

When using this product

• drowsiness will occur • avoid alcoholic drinks

• do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness

• pain gets worse or lasts more than 10 days

• fever gets worse or lasts more than 3 days

• redness or swelling is present  • new symptoms occur 

  These could be signs of a serious condition.

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

Uses

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

Purpose

Pain reliever

Nighttime sleep aid

Directions

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

 adults and children 12 years 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

Other Information

• store at controlled room temperature 20–25°C (68–77°F)

• protect from light, heat and moisture

Inactive Ingredients

FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinyl pyrrolidone,

pregelatinized starch, stearic acid powder, titanium dioxide

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Section 42229-5

COMPARE TO TYLENOL® PM EXTRA STRENGTH ACTIVE INGREDIENTS*

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

WWW.MEIJER.COM

PRODUCT OF INDIA

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

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

Section 50565-1

Keep out of reach of children.

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

Packaging

Drug Facts

Questions Or Comments?

1-888-577-8033 Monday - Friday 8am - 4pm EST

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg


Structured Label Content

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:

• skin reddening  • blisters  • rash

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

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.

• with any other product containing diphenhydramine, even one used on skin

• in children under 12 years of age

• if you have ever had an allergic reaction to this product or any of its ingredients

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

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers

When using this product

• drowsiness will occur • avoid alcoholic drinks

• do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

• sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness

• pain gets worse or lasts more than 10 days

• fever gets worse or lasts more than 3 days

• redness or swelling is present  • new symptoms occur 

  These could be signs of a serious condition.

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

Uses

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

Purpose

Pain reliever

Nighttime sleep aid

Directions

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

 adults and children 12 years 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

Other Information (Other information)

• store at controlled room temperature 20–25°C (68–77°F)

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

FD&C Blue No. 1, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinyl pyrrolidone,

pregelatinized starch, stearic acid powder, titanium dioxide

Section 42229-5 (42229-5)

COMPARE TO TYLENOL® PM EXTRA STRENGTH ACTIVE INGREDIENTS*

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

WWW.MEIJER.COM

PRODUCT OF INDIA

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

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

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Packaging

Drug Facts

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday - Friday 8am - 4pm EST

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)