Extra Strength Acetaminophen Pm Caplets

SPL v3

SPL

SPL Set ID 2560126e-a54a-4a47-9631-a1bca42f5277

Route

ORAL

Published

Effective Date 2022-01-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Croscarmellose Sodium Fd&c Blue No. 1 Fd&c Blue No. 2 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Water Silicon Dioxide Sodium Starch Glycolate Type A Starch, Corn Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: S149 Shape: oval Color: blue Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-05-01

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 500mg	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

in children under 12 years of age
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
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. 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 between 20-25°C (68-77°F)

Inactive Ingredients

croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, purified water, silicon dioxide, sodium starch glycolate, corn starch, talc, titanium dioxide

Questions Or Comments?

call 1-800-632-6900

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

Principal Display Panel 100 Caplet Bottle Carton

COMPARE TO the active ingredients of

TYLENOL^® PM EXTRA STRENGTH CAPLETS *See side panel

NDC 30142-755-01

Kroger_®

for adults

Extra Strength

Acetaminophen PM

Acetaminophen,

Diphenhydramine HCl

Pain Reliever/Nighttime Sleep-Aid

Non-Habit Forming

OUR PHARMACIST RECOMMENDED

actual

size

100 CAPLETS

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 500mg	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)

in children under 12 years of age
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
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 at room temperature between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

call 1-800-632-6900

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

Principal Display Panel 100 Caplet Bottle Carton (PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Carton)

COMPARE TO the active ingredients of

TYLENOL^® PM EXTRA STRENGTH CAPLETS *See side panel

NDC 30142-755-01

Kroger_®

for adults

Extra Strength

Acetaminophen PM

Acetaminophen,

Diphenhydramine HCl

Pain Reliever/Nighttime Sleep-Aid

Non-Habit Forming

OUR PHARMACIST RECOMMENDED

actual

size

100 CAPLETS

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 500mg 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": "in children under 12 years of age 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 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. 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 between 20-25°C (68-77°F)", "Inactive ingredients": "croscarmellose sodium, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, purified water, silicon dioxide, sodium starch glycolate, corn starch, talc, titanium dioxide", "Questions or comments?": "call 1-800-632-6900", "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", "PRINCIPAL DISPLAY PANEL - 100 Caplet Bottle Carton": "COMPARE TO the active ingredients of TYLENOL ® PM EXTRA STRENGTH CAPLETS *See side panel NDC 30142-755-01 Kroger ® for adults Extra Strength Acetaminophen PM Acetaminophen, Diphenhydramine HCl Pain Reliever/Nighttime Sleep-Aid Non-Habit Forming OUR PHARMACIST RECOMMENDED actual size 100 CAPLETS"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:41.403767 · Updated: 2026-03-14T23:02:23.126471