Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 44fe7e2b-13d4-4f7b-a39b-b61afcbace3b

Route

ORAL

Published

Effective Date 2011-01-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Starch, Corn Fd&c Blue No. 1 Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol 6000 Sodium Starch Glycolate Type A Potato Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: PM Shape: round Color: blue Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2011-01-28

Description

Acetaminophen 500mg Diphenhydramine HCl 25mg

Purpose

Pain reliever Sleep aid

Medication Information

Purpose

Pain reliever

Sleep aid

Description

Acetaminophen 500mg Diphenhydramine HCl 25mg

Uses

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

Section 51945-4

non-aspirin PM

Warnings

Enter section text here

Directions

Do not take more than directed (see overdose warning)

adults and children under 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Do Not Use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a 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

Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000ms of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Other Information

do not use if safety seal under cap is broken or missing
store between 20-25 °C (68-77 °F)
see end panel for lot number and expiration date

Overdose Warning:

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Inactive Ingredients

corn starch, cydroxypropyl cellulose, hypromellose 2910, blue no.1, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium starch glycolate, titanium dioxide

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
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.

Keep Out of Reach of Children.

Enter section text here

Active Ingredients (in Each Caplet)

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

Uses

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

Section 51945-4 (51945-4)

non-aspirin PM

Purpose

Pain reliever

Sleep aid

Warnings

Enter section text here

Directions

Do not take more than directed (see overdose warning)

adults and children under 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

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 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

Liver Warning: (Liver warning:)

This product contains acetaminophen. Severe liver damage may occur if you take

more than 4,000ms of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Other Information (Other information)

do not use if safety seal under cap is broken or missing
store between 20-25 °C (68-77 °F)
see end panel for lot number and expiration date

Overdose Warning: (Overdose warning:)

Inactive Ingredients (Inactive ingredients)

corn starch, cydroxypropyl cellulose, hypromellose 2910, blue no.1, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium starch glycolate, titanium dioxide

When Using This Product (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 (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
redness or swelling is present
new symptoms occur

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.)

Enter section text here

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

Acetaminophen 500mg

Diphenhydramine HCl 25mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

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

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
taking sedatives or tranquilizers

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 sleeplessnes", "51945-4": "non-aspirin PM", "Purpose": "Pain reliever Sleep aid", "Warnings": "Enter section text here", "Directions": "Do not take more than directed (see overdose warning) adults and children under 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 this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage", "Do not use": "with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a 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", "Liver warning:": "This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000ms of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product", "Other information": "do not use if safety seal under cap is broken or missing store between 20-25 °C (68-77 °F) see end panel for lot number and expiration date", "Overdose warning:": "Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Inactive ingredients": "corn starch, cydroxypropyl cellulose, hypromellose 2910, blue no.1, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, sodium starch glycolate, titanium dioxide", "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 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.", "Keep out of reach of children.": "Enter section text here", "Active Ingredients (in each caplet)": "Acetaminophen 500mg Diphenhydramine HCl 25mg", "Ask a doctor before use if you have": "liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:12.234514 · Updated: 2026-03-14T22:52:34.752454