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SPL v2

SPL

SPL Set ID 70084eea-1480-4c46-b849-4c779319cb74

Route

ORAL

Published

Effective Date 2025-02-19

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 Silicon Dioxide Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol Starch, Pregelatinized Corn Povidone K30 Sodium Starch Glycolate Type A Corn Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: APM Shape: oval Color: blue Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-02-01

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

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

Questions?

call toll free 1-844-912-4012

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

Allergy Alert:

acetaminophen may cause severe skin reactions.

Symptoms may include:

■ skin reddening ■ blisters ■ rash

If a skin reaction occurs, stop use and seek medical help right away

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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)
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients

brilliant blue lake, colloidal silicon dioxide, indigo carmine lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, PVP-K30, sodium starch glycolate, stearic acid, talc, 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
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.

Principal Display Panel 100 Count

NDC 37835-537-01

Compare to the active ingredients in Extra Strength Tylenol ^®PM*

EXTRA STRENGTH PAIN RELIEVER PM

Acetaminophen, Diphenhydramine HCl

Pain Reliever / Nighttime Sleep Aid

100 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Extra Strength Tylenol ^®PM.

Distributed by:

BI-MART

Eugene, OR 97402

Principal Display Panel 250 Count

NDC 37835-537-25

Compare to the active ingredients in Extra Strength Tylenol ^®PM*

EXTRA STRENGTH PAIN RELIEVER PM

Acetaminophen, Diphenhydramine HCl

Pain Reliever / Nighttime Sleep Aid

250 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Extra Strength Tylenol ^®PM.

Distributed by:

BI-MART

Eugene, OR 97402

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

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

Questions?

call toll free 1-844-912-4012

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

Allergy Alert: (Allergy alert:)

acetaminophen may cause severe skin reactions.

Symptoms may include:

■ skin reddening ■ blisters ■ rash

If a skin reaction occurs, stop use and seek medical help right away

Overdose Warning (Overdose warning)

Other Information (Other information)

store between 20-25°C (68-77°F)
DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED

Inactive Ingredients (Inactive ingredients)

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.

Principal Display Panel 100 Count (PRINCIPAL DISPLAY PANEL-100 Count)

NDC 37835-537-01

Compare to the active ingredients in Extra Strength Tylenol ^®PM*

EXTRA STRENGTH PAIN RELIEVER PM

Acetaminophen, Diphenhydramine HCl

Pain Reliever / Nighttime Sleep Aid

100 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Extra Strength Tylenol ^®PM.

Distributed by:

BI-MART

Eugene, OR 97402

Principal Display Panel 250 Count (PRINCIPAL DISPLAY PANEL-250 Count)

NDC 37835-537-25

Compare to the active ingredients in Extra Strength Tylenol ^®PM*

EXTRA STRENGTH PAIN RELIEVER PM

Acetaminophen, Diphenhydramine HCl

Pain Reliever / Nighttime Sleep Aid

250 Caplets

*This product is not manufactured or distributed by the owner of the registered trademark Extra Strength Tylenol ^®PM.

Distributed by:

BI-MART

Eugene, OR 97402

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", "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", "Questions?": "call toll free 1-844-912-4012", "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", "Allergy alert:": "acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash If a skin reaction occurs, stop use and seek medical help right away", "Overdose warning": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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) DO NOT USE IF PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED", "Inactive ingredients": "brilliant blue lake, colloidal silicon dioxide, indigo carmine lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, PVP-K30, sodium starch glycolate, stearic acid, talc, 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 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.", "PRINCIPAL DISPLAY PANEL-100 Count": "NDC 37835-537-01 Compare to the active ingredients in Extra Strength Tylenol ® PM* EXTRA STRENGTH PAIN RELIEVER PM Acetaminophen, Diphenhydramine HCl Pain Reliever / Nighttime Sleep Aid 100 Caplets *This product is not manufactured or distributed by the owner of the registered trademark Extra Strength Tylenol ® PM. Distributed by: BI-MART Eugene, OR 97402", "PRINCIPAL DISPLAY PANEL-250 Count": "NDC 37835-537-25 Compare to the active ingredients in Extra Strength Tylenol ® PM* EXTRA STRENGTH PAIN RELIEVER PM Acetaminophen, Diphenhydramine HCl Pain Reliever / Nighttime Sleep Aid 250 Caplets *This product is not manufactured or distributed by the owner of the registered trademark Extra Strength Tylenol ® PM. Distributed by: BI-MART Eugene, OR 97402", "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: 2026-02-15T12:06:26.940337 · Updated: 2026-03-14T23:09:13.832086