Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 3b23220a-ffb4-463f-9fe2-2783b338fd93

Route

ORAL

Published

Effective Date 2013-04-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Croscarmellose Sodium Crospovidone Fd&c Blue No. 1 Hypromelloses Magnesium Stearate Cellulose, Microcrystalline Povidones Propylene Glycol Silicon Dioxide Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: GP325 Shape: oval Color: white Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-04-29

Description

Acetaminophen 500 mg Diphenhydramine HCl 25mg

Purpose

Pain RelieverNighttime Sleep Aid

Medication Information

Purpose

Pain RelieverNighttime Sleep Aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25mg

Uses

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

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Purposes

Pain RelieverNighttime Sleep Aid

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

Questions?

If you have any questions or comments. or to report an adverse event, please contact (xxx) xxx-xxxx.

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.

Other Information

Store at room temperature

Inactive Ingredients

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Principal Display Panel

healthy

mama

eaZZZe THE PAIN!

acetaminophen 500mg diphenhydramine HCl 25 mg

PAIN RELIEVER AND NIGHTTIME AID

extra strength aspirin free

40 caplets

When Using This Prodcut

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 a serious underlying medical illness.
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.

Active Ingredient (in Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25mg

Ask A Doctor Before Use If You Are

liver disease
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
glaucoma

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 with pains with accompanying sleeplessness.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53414-9 (53414-9)

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

Purposes

Pain RelieverNighttime Sleep Aid

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

Questions?

If you have any questions or comments. or to report an adverse event, please contact (xxx) xxx-xxxx.

Overdose Warning (Overdose warning)

Other Information (Other information)

Store at room temperature

Inactive Ingredients (Inactive ingredients)

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Principal Display Panel

healthy

mama

eaZZZe THE PAIN!

acetaminophen 500mg diphenhydramine HCl 25 mg

PAIN RELIEVER AND NIGHTTIME AID

extra strength aspirin free

40 caplets

When Using This Prodcut (When using this prodcut)

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 a serious underlying medical illness.
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.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Acetaminophen 500 mg

Diphenhydramine HCl 25mg

Ask A Doctor Before Use If You Are (Ask a doctor before use if you are)

liver disease
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland
glaucoma

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 with pains with accompanying sleeplessness.", "50565-1": "Keep out of reach of children.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purposes": "Pain RelieverNighttime Sleep Aid", "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 everyday 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. In children under 12 years of age with any other product containing diphenhydramine, even one used on skin if you have ever had an allergic reaction to this product or any of its ingredients", "Questions?": "If you have any questions or comments. or to report an adverse event, please contact (xxx) xxx-xxxx.", "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.", "Other information": "Store at room temperature", "Inactive ingredients": "Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.", "Principal Display Panel": "healthy mama eaZZZe THE PAIN! acetaminophen 500mg diphenhydramine HCl 25 mg PAIN RELIEVER AND NIGHTTIME AID extra strength aspirin free 40 caplets", "When using this prodcut": "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 a serious underlying medical illness. 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.", "Active ingredient (in each caplet)": "Acetaminophen 500 mg Diphenhydramine HCl 25mg", "Ask a doctor before use if you are": "liver disease a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma", "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: 2026-02-15T11:55:37.803937 · Updated: 2026-03-14T22:53:29.712463