Kroger 44-367-delisted

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (25 mg)

Inactive Ingredients

Starch, Corn Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Stearic Acid Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 44;367 Shape: oval Color: blue Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2021-05-03 Until 2026-04-30

Medication Information

Purpose

Nighttime sleep-aid

Description

Diphenhydramine HCl 25 mg

Use

for relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Directions

do not take more than directed
adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
children under 12 years: do not use

Do Not Use

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Other Information

each caplet contains: calcium 30 mg
protect from moisture
store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of SIMPLY SLEEP^® *See bottom panel

NDC 30142-367-12

Kroger_®

Nighttime

Sleep Aid

Diphenhydramine HCI 25 mg

Nighttime Sleep-Aid

Non-Habit

Forming

Does Not Contain

Pain Reliever

actual

size

100 CAPLETS

OUR PHARMACIST

RECOMMENDED

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER CAP IS

BROKEN OR MISSING

*Simply Sleep^® is a registered trademark of Johnson

& Johnson, New Brunswick, NJ 08933. Johnson &

Johnson is not affiliated with The Kroger Co.

or this product.

50844 ORG101936712

Our Brands. Our Guarantee.

Love It or Your Money Back.

www.kroger.com

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

FOR MORE PRODUCT

INFORMATION, SCAN UPC

USING YOUR KROGER APP

OR CALL 800-632-6900

PLEASE

RECYCLE

44-367

When Using This Product

avoid alcoholic beverages.

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.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Caplet)

Diphenhydramine HCl 25 mg

Ask A Doctor Before Use If You Have

a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Use

for relief of occasional sleeplessness
reduces time to fall asleep if you have difficulty falling asleep

Purpose

Nighttime sleep-aid

Directions

do not take more than directed
adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor
children under 12 years: do not use

Do Not Use (Do not use)

for children under 12 years of age
with any other product containing diphenhydramine, even one used on skin

Other Information (Other information)

each caplet contains: calcium 30 mg
protect from moisture
store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of SIMPLY SLEEP^® *See bottom panel

NDC 30142-367-12

Kroger_®

Nighttime

Sleep Aid

Diphenhydramine HCI 25 mg

Nighttime Sleep-Aid

Non-Habit

Forming

Does Not Contain

Pain Reliever

actual

size

100 CAPLETS

OUR PHARMACIST

RECOMMENDED

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER CAP IS

BROKEN OR MISSING

*Simply Sleep^® is a registered trademark of Johnson

& Johnson, New Brunswick, NJ 08933. Johnson &

Johnson is not affiliated with The Kroger Co.

or this product.

50844 ORG101936712

Our Brands. Our Guarantee.

Love It or Your Money Back.

www.kroger.com

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

FOR MORE PRODUCT

INFORMATION, SCAN UPC

USING YOUR KROGER APP

OR CALL 800-632-6900

PLEASE

RECYCLE

44-367

When Using This Product (When using this product)

avoid alcoholic beverages.

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Diphenhydramine HCl 25 mg

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

a breathing problem such as emphysema or chronic bronchitis
glaucoma
difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1 ALUMINUM LAKE", "unii": "J9EQA3S2JM", "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, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "for relief of occasional sleeplessness reduces time to fall asleep if you have difficulty falling asleep", "Purpose": "Nighttime sleep-aid", "Directions": "do not take more than directed adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by a doctor children under 12 years: do not use", "Do not use": "for children under 12 years of age with any other product containing diphenhydramine, even one used on skin", "Other information": "each caplet contains: calcium 30 mg protect from moisture store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number", "Inactive ingredients": "corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide", "Questions or comments?": "1-800-632-6900", "Principal Display Panel": "COMPARE TO the active ingredient of SIMPLY SLEEP ® *See bottom panel NDC 30142-367-12 Kroger ® Nighttime Sleep Aid Diphenhydramine HCI 25 mg Nighttime Sleep-Aid Non-Habit Forming Does Not Contain Pain Reliever actual size 100 CAPLETS OUR PHARMACIST RECOMMENDED TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING *Simply Sleep ® is a registered trademark of Johnson & Johnson, New Brunswick, NJ 08933. Johnson & Johnson is not affiliated with The Kroger Co. or this product. 50844 ORG101936712 Our Brands. Our Guarantee. Love It or Your Money Back. www.kroger.com DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900 PLEASE RECYCLE 44-367", "When using this product": "avoid alcoholic beverages.", "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.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Active ingredient (in each caplet)": "Diphenhydramine HCl 25 mg", "Ask a doctor before use if you have": "a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information