DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Croscarmellose Sodium Fd&c Blue No. 1 Cellulose, Microcrystalline Stearic Acid Titanium Dioxide Polyethylene Glycols Hypromelloses

Identifiers & Packaging

Pill Appearance

Imprint: P24 Shape: capsule Color: blue Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-06-20

Medication Information

Purpose

Pain reliever

Nighttime sleep aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Use(s)

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

Storage

store between 20-25°C (68-77°F)
do not use is carton is opened, or neck wrap or foil inner seal imprinted "Safety Seal®" is broken or missing
see end panel for lot number and expiration date

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

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 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 doctor or pharmacist.
with any 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

Active Ingredient(s)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Pregnancy/breastfeeding

Ask a health professional before use.

Principal Display Panel

Carton Label PDP

Drug mart

EXTRA STRENGTH

PAIN RELIEF PM

NON-ASPIRIN PAIN RELIEVER/ SLEEP AID

CAPLETS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

50 COATED CAPLETS

Bottle Label PDP

Drug mart

EXTRA STRENGTH

PAIN RELIEF PM

NON-ASPIRIN PAIN RELIEVER/ SLEEP AID

CAPLETS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

50 COATED CAPLETS

CARTON LABEL PDP

Drug mart

EXTRA STRENGTH

PAIN RELIEF PM

NON-ASPIRIN PAIN RELIEVER/ SLEEP AID

CAPLETS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

100 COATED CAPLETS

Bottle Label PDP

Drug mart

EXTRA STRENGTH

PAIN RELIEF PM

NON-ASPIRIN PAIN RELIEVER/ SLEEP AID

CAPLETS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

100 COATED CAPLETS

Bottle Label PDP

Drug mart

EXTRA STRENGTH

PAIN RELIEF PM

NON-ASPIRIN PAIN RELIEVER/ SLEEP AID

CAPLETS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

300 COATED CAPLETS

When Using This Product

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

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

Stop Use and Ask 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.

Inactive Ingredient Section

Croscarmellose sodium, FD&C blue #1, Hypromellose, Microcrsytalline cellulose, Polyethylene glycol, Stearic acid, Titanium Dioxide.

Keep Out of Reach of Children

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. (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.

Ask A Doctor Or Pharmacist Before Use If

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

Use(s) (USE(S))

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

Purpose (PURPOSE)

Pain reliever

Nighttime sleep aid

Storage (STORAGE)

store between 20-25°C (68-77°F)
do not use is carton is opened, or neck wrap or foil inner seal imprinted "Safety Seal®" is broken or missing
see end panel for lot number and expiration date

Warnings (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

Directions (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 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 doctor or pharmacist.
with any 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

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Pregnancy/breastfeeding (PREGNANCY/BREASTFEEDING)

Ask a health professional before use.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Carton Label PDP

Drug mart

EXTRA STRENGTH

PAIN RELIEF PM

NON-ASPIRIN PAIN RELIEVER/ SLEEP AID

CAPLETS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

50 COATED CAPLETS

Bottle Label PDP

Drug mart

EXTRA STRENGTH

PAIN RELIEF PM

NON-ASPIRIN PAIN RELIEVER/ SLEEP AID

CAPLETS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

50 COATED CAPLETS

CARTON LABEL PDP

Drug mart

EXTRA STRENGTH

PAIN RELIEF PM

NON-ASPIRIN PAIN RELIEVER/ SLEEP AID

CAPLETS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

100 COATED CAPLETS

Bottle Label PDP

Drug mart

EXTRA STRENGTH

PAIN RELIEF PM

NON-ASPIRIN PAIN RELIEVER/ SLEEP AID

CAPLETS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

100 COATED CAPLETS

Bottle Label PDP

Drug mart

EXTRA STRENGTH

PAIN RELIEF PM

NON-ASPIRIN PAIN RELIEVER/ SLEEP AID

CAPLETS

ACETAMINOPHEN 500 mg

DIPHENHYDRAMINE HCl 25 mg

300 COATED CAPLETS

When Using This Product (WHEN USING THIS PRODUCT)

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

Ask A Doctor Before Use If (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

Stop Use and Ask Doctor If (STOP USE AND ASK 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.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Croscarmellose sodium, FD&C blue #1, Hypromellose, Microcrsytalline cellulose, Polyethylene glycol, Stearic acid, Titanium Dioxide.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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. (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.

Ask A Doctor Or Pharmacist Before Use If (ASK A DOCTOR OR PHARMACIST BEFORE USE IF)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOLS", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "Temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness", "PURPOSE": "Pain reliever Nighttime sleep aid", "STORAGE": "store between 20-25°C (68-77°F) do not use is carton is opened, or neck wrap or foil inner seal imprinted "Safety Seal®" is broken or missing see end panel for lot number and expiration date", "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", "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 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 doctor or pharmacist. with any 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", "ACTIVE INGREDIENT(S)": "Acetaminophen 500 mg Diphenhydramine HCl 25 mg", "PREGNANCY/BREASTFEEDING": "Ask a health professional before use.", "PRINCIPAL DISPLAY PANEL": "Carton Label PDP Drug mart EXTRA STRENGTH PAIN RELIEF PM NON-ASPIRIN PAIN RELIEVER/ SLEEP AID CAPLETS ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HCl 25 mg 50 COATED CAPLETS Bottle Label PDP Drug mart EXTRA STRENGTH PAIN RELIEF PM NON-ASPIRIN PAIN RELIEVER/ SLEEP AID CAPLETS ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HCl 25 mg 50 COATED CAPLETS CARTON LABEL PDP Drug mart EXTRA STRENGTH PAIN RELIEF PM NON-ASPIRIN PAIN RELIEVER/ SLEEP AID CAPLETS ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HCl 25 mg 100 COATED CAPLETS Bottle Label PDP Drug mart EXTRA STRENGTH PAIN RELIEF PM NON-ASPIRIN PAIN RELIEVER/ SLEEP AID CAPLETS ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HCl 25 mg 100 COATED CAPLETS Bottle Label PDP Drug mart EXTRA STRENGTH PAIN RELIEF PM NON-ASPIRIN PAIN RELIEVER/ SLEEP AID CAPLETS ACETAMINOPHEN 500 mg DIPHENHYDRAMINE HCl 25 mg 300 COATED CAPLETS", "WHEN USING THIS PRODUCT": "drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery", "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", "STOP USE AND ASK 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.", "INACTIVE INGREDIENT SECTION": "Croscarmellose sodium, FD&C blue #1, Hypromellose, Microcrsytalline cellulose, Polyethylene glycol, Stearic acid, Titanium Dioxide. ", "KEEP OUT OF REACH OF CHILDREN": "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. (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.", "ASK A DOCTOR OR PHARMACIST BEFORE USE IF": "taking the blood thinning drug warfarin taking sedatives or tranquilizers"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information