Pain Relief Pm (pain Reliever & Nighttime Sleep Aid)

SPL v7

SPL

SPL Set ID 6689bf70-1283-4332-88d3-c74bcee89f93

Route

ORAL

Published

Effective Date 2020-07-02

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 Hypromelloses Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 400 Povidone K30 Starch, Pregelatinized Corn Water Stearic Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: S525 Shape: oval Color: blue Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-07-02

Description

Drug Facts

Purpose

Pain reliever Nighttime sleep aid

Medication Information

Warnings and Precautions

Warnings

Purpose

Pain reliever

Nighttime sleep aid

Description

Drug Facts

Uses

For the 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.

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 other drug 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

Liver Warning

This product contains acetaminophen. Severe liver damage may occur with this product 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 you are using this product

Overdose Warning

Taking more than the directed 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

each caplet contains: magnesium 0.05 mg
store between 20°-25°C (68°-77°F)

Inactive Ingredients

FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, povidone k-30, pregelatinized starch, purified water, stearic acid, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Extra Strength

Pain Relief PM

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Pain Reliever/Nighttime Sleep-Aid

100 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 a serious underlying medical illness
pain gets worse or lasts for 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 Ingredients (in Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

liver disease
breathing problems such as emphysema or chronic bronchitis
trouble urinating due to an 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

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

Warnings and Precautions (34071-1)

Warnings

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.

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 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 other drug 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

Liver Warning (Liver warning)

This product contains acetaminophen. Severe liver damage may occur with this product 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 you are using this product

Overdose Warning (Overdose warning)

Taking more than the directed 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 (Other information)

each caplet contains: magnesium 0.05 mg
store between 20°-25°C (68°-77°F)

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Extra Strength

Pain Relief PM

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Pain Reliever/Nighttime Sleep-Aid

100 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 a serious underlying medical illness
pain gets worse or lasts for 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 Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

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

liver disease
breathing problems such as emphysema or chronic bronchitis
trouble urinating due to an 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

[{"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 2", "unii": "L06K8R7DQK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSES", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 400", "unii": "B697894SGQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, PREGELATINIZED CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "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": "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"}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness", "34071-1": "Warnings", "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.", "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 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 other drug 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", "Liver warning": "This product contains acetaminophen. Severe liver damage may occur with this product 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 you are using this product", "Overdose warning": "Taking more than the directed 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": "each caplet contains: magnesium 0.05 mg store between 20°-25°C (68°-77°F)", "Inactive ingredients": "FD&C blue # 1, FD&C blue # 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-400, povidone k-30, pregelatinized starch, purified water, stearic acid, titanium dioxide", "Questions or comments?": "1-888-333-9792", "PRINCIPAL DISPLAY PANEL": "Extra Strength Pain Relief PM Acetaminophen 500 mg Diphenhydramine HCl 25 mg Pain Reliever/Nighttime Sleep-Aid 100 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 a serious underlying medical illness pain gets worse or lasts for 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 ingredients (in each caplet)": "Acetaminophen 500 mg Diphenhydramine HCl 25 mg", "Ask a doctor before use if you have": "liver disease breathing problems such as emphysema or chronic bronchitis trouble urinating due to an 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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:48.423153 · Updated: 2026-03-14T23:05:48.377821