Qch - 1095 - 2019-1004

SPL v6

SPL

SPL Set ID 475becec-1a56-4cfa-a0c5-562f8772adfb

Route

ORAL

Published

Effective Date 2014-10-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Silicon Dioxide Copovidone K25-31 Croscarmellose Sodium Fd&c Blue No. 1 Hypromellose, Unspecified Lactose Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Povidone, Unspecified Starch, Corn Sodium Starch Glycolate Type A Corn Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: AAA;1031 Shape: oval Color: blue Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2007-11-08 Until 2026-11-30

Description

Drug Facts

Medication Information

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Section 53414-9

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

Section 55105-1

Active ingredients (in each caplet)	Purpose
Acetaminophen 500 mg	Pain reliever
Diphenhydramine HCl 25 mg	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 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 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 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Overdose Warning

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 between 20-25°C (68-77°F) in a dry place
retain carton for complete product information

Inactive Ingredients

colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Principal Display Panel

NDC 63868-325-50

QUALITY CHOICE

†Compare to Extra Strength TYLENOL® PM active ingredients

Extra Strength

Pain Relief PM

Pain Reliever, Nighttime Sleep Aid

Acetaminophen, Diphenhydramine HCl

50 Caplets

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.

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

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

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.

Section 55105-1 (55105-1)

Active ingredients (in each caplet)	Purpose
Acetaminophen 500 mg	Pain reliever
Diphenhydramine HCl 25 mg	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 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 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 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Overdose Warning (Overdose warning)

Other Information (Other information)

store between 20-25°C (68-77°F) in a dry place
retain carton for complete product information

Inactive Ingredients (Inactive ingredients)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 63868-325-50

QUALITY CHOICE

†Compare to Extra Strength TYLENOL® PM active ingredients

Extra Strength

Pain Relief PM

Pain Reliever, Nighttime Sleep Aid

Acetaminophen, Diphenhydramine HCl

50 Caplets

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
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.

Ask A Doctor Before Use If You Have (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 (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 sleeplessness", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Diphenhydramine HCl 25 mg 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 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 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 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product", "Overdose warning": "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 between 20-25°C (68-77°F) in a dry place retain carton for complete product information", "Inactive ingredients": "colloidal silicon dioxide, copovidone, croscarmellose sodium, FD&C blue #1, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide", "PRINCIPAL DISPLAY PANEL": "NDC 63868-325-50 QUALITY CHOICE †Compare to Extra Strength TYLENOL® PM active ingredients Extra Strength Pain Relief PM Pain Reliever, Nighttime Sleep Aid Acetaminophen, Diphenhydramine HCl 50 Caplets", "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.", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:45.722187 · Updated: 2026-03-14T23:03:59.769884