Acetaminophen Pm Extra Strength Caplets

SPL v5

SPL

SPL Set ID d82cf6f3-a291-ca2b-e053-2a95a90a6de1

Route

ORAL

Published

Effective Date 2023-12-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Diphenhydramine (25 mg)

Inactive Ingredients

Calcium Carbonate Rice Bran Powdered Cellulose Inulin Palm Oil Acacia Agave Tequilana Juice Carnauba Wax Dextrose Guar Gum Maltodextrin Sodium Bicarbonate Lecithin, Sunflower Glyceryl Dibehenate Sunflower Oil Glycerin

Identifiers & Packaging

Pill Appearance

Imprint: G7 Shape: oval Color: white Size: 18 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2022-02-17

Description

Drug Facts

Medication Information

Warnings and Precautions

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 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.

Indications and Usage

Uses

temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage and Administration

Directions

• do not take more than directed (see Overdose warning)

adults and children 12 years and over	take 2 caplets at bedtime if needed do not take more than 2 caplets in 24 hours, unless directed by a doctor
children under 12 years	ask a doctor

Description

Drug Facts

Section 34088-5

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 42229-5

Drug Facts

Section 43683-2

Directions

• do not take more than directed (see Overdose warning)

adults and children 12 years and over	take 2 caplets at bedtime if needed do not take more than 2 caplets in 24 hours, unless directed by a doctor
children under 12 years	ask a doctor

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 50567-7

When using this product

drowsiness will occur
avoid alcoholic drinks
do not drive a motor vehicle or operate machinery

Section 50568-5

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if you have

liver disease
glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland

Section 50570-1

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 the skin
in children under 12 years of age
if you have ever had an allergic reaction to this product or any of its ingredients

Section 51727-6

Inactive ingredients

acacia gum‡, agave fiber‡, agave syrup‡, calcium carbonate‡, organic carnauba wax, cellulose‡, dextrose‡, dibehenin (vegetable source)‡, glycerin‡, guar gum‡, maltodextrin‡, organic palm olein, rice extract‡, rice hulls‡, sodium bicarbonate‡, organic sunflower lecithin, sunflower oil‡

‡natural

Section 51945-4

Genexa®

MEDICINE MADE CLEAN

For Adults

Acetaminophen PM Extra Strength

with Diphenhydramine HCl

Pain Reliever Nighttime Sleep Aid

Compare to active ingredients in Tylenol® PM Extra Strength Caplets*

100 Caplets

Non-habit forming

How we're different

Made without: crospovidone, polyethylene glycol, titanium dioxide & more!

Section 53413-1

Questions? 1-855-436-3921

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever

Nighttime sleep aid

Section 55106-9

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Section 60561-8

Other information

each caplet contains: calcium 12 mg
store between 20-25°C (68-77°F)

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage and Administration (34068-7)

Directions

• do not take more than directed (see Overdose warning)

adults and children 12 years and over	take 2 caplets at bedtime if needed do not take more than 2 caplets in 24 hours, unless directed by a doctor
children under 12 years	ask a doctor

Warnings and Precautions (34071-1)

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 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.

Section 34088-5 (34088-5)

Section 42229-5 (42229-5)

Drug Facts

Section 43683-2 (43683-2)

Directions

• do not take more than directed (see Overdose warning)

adults and children 12 years and over	take 2 caplets at bedtime if needed do not take more than 2 caplets in 24 hours, unless directed by a doctor
children under 12 years	ask a doctor

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

When using this product

drowsiness will occur
avoid alcoholic drinks
do not drive a motor vehicle or operate machinery

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if you have

liver disease
glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged prostate gland

Section 50570-1 (50570-1)

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 the skin
in children under 12 years of age
if you have ever had an allergic reaction to this product or any of its ingredients

Section 51727-6 (51727-6)

Inactive ingredients

‡natural

Section 51945-4 (51945-4)

Genexa®

MEDICINE MADE CLEAN

For Adults

Acetaminophen PM Extra Strength

with Diphenhydramine HCl

Pain Reliever Nighttime Sleep Aid

Compare to active ingredients in Tylenol® PM Extra Strength Caplets*

100 Caplets

Non-habit forming

How we're different

Made without: crospovidone, polyethylene glycol, titanium dioxide & more!

Section 53413-1 (53413-1)

Questions? 1-855-436-3921

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever

Nighttime sleep aid

Section 55106-9 (55106-9)

Active ingredients (in each caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg

Section 60561-8 (60561-8)

Other information

each caplet contains: calcium 12 mg
store between 20-25°C (68-77°F)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily relieves occasional headaches and minor aches and pains with accompanying sleeplessness", "34068-7": "Directions • do not take more than directed (see Overdose warning) adults and children 12 years and over take 2 caplets at bedtime if needed do not take more than 2 caplets in 24 hours, unless directed by a doctor children under 12 years ask a doctor", "34071-1": "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 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.", "34088-5": "Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "42229-5": "Drug Facts", "43683-2": "Directions • do not take more than directed (see Overdose warning) adults and children 12 years and over take 2 caplets at bedtime if needed do not take more than 2 caplets in 24 hours, unless directed by a doctor children under 12 years ask a doctor", "50565-1": "Keep out of reach of children.", "50566-9": "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.", "50567-7": "When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery", "50568-5": "Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers", "50569-3": "Ask a doctor before use if you have liver disease glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland", "50570-1": "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 the skin in children under 12 years of age if you have ever had an allergic reaction to this product or any of its ingredients", "51727-6": "Inactive ingredients acacia gum‡, agave fiber‡, agave syrup‡, calcium carbonate‡, organic carnauba wax, cellulose‡, dextrose‡, dibehenin (vegetable source)‡, glycerin‡, guar gum‡, maltodextrin‡, organic palm olein, rice extract‡, rice hulls‡, sodium bicarbonate‡, organic sunflower lecithin, sunflower oil‡ ‡natural", "51945-4": "Genexa® MEDICINE MADE CLEAN For Adults Acetaminophen PM Extra Strength with Diphenhydramine HCl Pain Reliever Nighttime Sleep Aid Compare to a ctive ingredients in Tylenol® PM Extra Strength Caplets* 100 Caplets Non-habit forming How we're different Made without: crospovidone, polyethylene glycol, titanium dioxide & more!", "53413-1": "Questions? 1-855-436-3921", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Pain reliever Nighttime sleep aid", "55106-9": "Active ingredients (in each caplet) Acetaminophen 500 mg Diphenhydramine HCl 25 mg", "60561-8": "Other information each caplet contains: calcium 12 mg store between 20-25°C (68-77°F)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:38.240298 · Updated: 2026-03-14T23:07:45.169331