Kroger Extra Strength Acetaminophen Pm Caplet

Kroger Extra Strength Acetaminophen Pm Caplet
SPL v2
SPL
SPL Set ID 24a75ffa-c2a7-71a9-e063-6394a90a0e25
Route
ORAL
Published
Effective Date 2024-12-18
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 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol 400 Povidone K30 Starch, Corn Stearic Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-17

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Purpose

Pain reliever Nighttime sleep aid


Medication Information

Purpose

Pain reliever

Nighttime sleep aid

Description

Acetaminophen 500 mg Diphenhydramine HCl 25 mg

Uses

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

Section 42229-5

Kroger® health

COMPARE TO THE ACTIVE INGREDIENTS OF TYLENOL® PM EXTRA STRENGTH*

NON-HABIT FORMING

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

*Tylenol® is a registered trademark of Kenvue Inc.

PROUDLY DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

PRODUCT OF INDIA

#OUR PHARMACIST RECOMMENDED

Our Brands. Our Guarantee. Love It or Your Money Back.

www.kroger.com

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

For More Product Information, Scan UPC Using Your Kroger App or Call 800-632-6900

Section 50565-1

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

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.

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

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 and tranquilizers

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 more than 10 days

• fever gets worse or lats more than 3 days.

• redness or swelling is present  • new symptoms occur. These could be signs of a serious condition.

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

Packaging

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

Drug Facts

Other Information

• store at room temperature between 20º-25ºC (68º-77ºF)

• protect from light, heat and moisture

Inactive Ingredients

FD&C blue no. 1, FD&C blue no. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinylpyrrolidone K30, pregelatinized starch, stearic acid powder, titanium dioxide

Questions Or Comments?

Call 1-800-632-6900

Active Ingredients (in Each Caplet)

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Kroger® health

COMPARE TO THE ACTIVE INGREDIENTS OF TYLENOL® PM EXTRA STRENGTH*

NON-HABIT FORMING

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

*Tylenol® is a registered trademark of Kenvue Inc.

PROUDLY DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

PRODUCT OF INDIA

#OUR PHARMACIST RECOMMENDED

Our Brands. Our Guarantee. Love It or Your Money Back.

www.kroger.com

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

For More Product Information, Scan UPC Using Your Kroger App or Call 800-632-6900

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 

Purpose

Pain reliever

Nighttime sleep aid

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.

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

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 and tranquilizers

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 more than 10 days

• fever gets worse or lats more than 3 days.

• redness or swelling is present  • new symptoms occur. These could be signs of a serious condition.

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

Packaging

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

Drug Facts

Other Information (Other information)

• store at room temperature between 20º-25ºC (68º-77ºF)

• protect from light, heat and moisture

Inactive Ingredients (Inactive ingredients)

FD&C blue no. 1, FD&C blue no. 2, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinylpyrrolidone K30, pregelatinized starch, stearic acid powder, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-800-632-6900

Active Ingredients (in Each Caplet) (Active ingredients (in each caplet))

Acetaminophen 500 mg

Diphenhydramine HCl 25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)