Kroger 44-386 Delisted

Drug Facts

Composition & Product

Active Ingredients

Doxylamine (25 mg)

Inactive Ingredients

Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance

Imprint: 44;386 Shape: oval Color: blue Size: 10 mm Score: 1

Marketing Status

ANDA Completed Since 2021-03-16 Until 2027-08-31

Medication Information

Purpose

Nighttime sleep-aid

Description

Doxylamine succinate 25 mg

Use

helps to reduce difficulty in falling asleep

Directions

adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
children under 12 years of age: do not use

Do Not Use

in children under 12 years of age
with any other product containing doxylamine
unless you have time for a full night’s sleep

Other Information

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at controlled room temperature 20°-25°C (68°-77°F)
see end flap for expiration date and lot number

Inactive Ingredients

dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient

of UNISOM^® SLEEPTABS^® _{*See back panel}

NDC 30142-386-27

Kroger_®

Nighttime Sleep-Aid

OUR PHARMACIST RECOMMENDED

Sleep Aid

Doxylamine Succinate

Tablets, 25 mg

Nighttime Sleep-Aid

actual

size

One Tablet

Per Dose

32 TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*Unisom^® and SleepTabs^® are registered trademarks of

Chattem, Inc., Chattanooga, TN 37409. Chattem, Inc. is

not affiliated with The Kroger Co. or this product.

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

FOR MORE PRODUCT INFORMATION, SCAN UPC

USING YOUR KROGER APP OR CALL 800-632-6900

50844 REV0123B38627

Our Brands. Our Guarantee.

Love It or Your Money Back.

www.kroger.com

PLEASE

RECYCLE

Kroger 44-386

When Using This Product

avoid alcoholic beverages
do not drive a motor vehicle or operate machinery
take only at bedtime

Stop Use and Ask A Doctor If

sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of 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 Tablet)

Doxylamine succinate 25 mg

Ask A Doctor Before Use If You Have

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking

sedatives or any other sleep-aid
tranquilizers
any other antihistamines
any other drugs

Structured Label Content

Use

helps to reduce difficulty in falling asleep

Purpose

Nighttime sleep-aid

Directions

adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor
children under 12 years of age: do not use

Do Not Use (Do not use)

in children under 12 years of age
with any other product containing doxylamine
unless you have time for a full night’s sleep

Other Information (Other information)

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
store at controlled room temperature 20°-25°C (68°-77°F)
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments? (Questions or comments?)

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient

of UNISOM^® SLEEPTABS^® _{*See back panel}

NDC 30142-386-27

Kroger_®

Nighttime Sleep-Aid

OUR PHARMACIST RECOMMENDED

Sleep Aid

Doxylamine Succinate

Tablets, 25 mg

Nighttime Sleep-Aid

actual

size

One Tablet

Per Dose

32 TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*Unisom^® and SleepTabs^® are registered trademarks of

Chattem, Inc., Chattanooga, TN 37409. Chattem, Inc. is

not affiliated with The Kroger Co. or this product.

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

FOR MORE PRODUCT INFORMATION, SCAN UPC

USING YOUR KROGER APP OR CALL 800-632-6900

50844 REV0123B38627

Our Brands. Our Guarantee.

Love It or Your Money Back.

www.kroger.com

PLEASE

RECYCLE

Kroger 44-386

When Using This Product (When using this product)

avoid alcoholic beverages
do not drive a motor vehicle or operate machinery
take only at bedtime

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of 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 Tablet) (Active ingredient (in each tablet))

Doxylamine succinate 25 mg

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

glaucoma
a breathing problem such as emphysema or chronic bronchitis
trouble urinating due to an enlarged 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 any other sleep-aid
tranquilizers
any other antihistamines
any other drugs

Advanced Ingredient Data

[{"name": "DOXYLAMINE", "unii": "95QB77JKPL", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"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": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "helps to reduce difficulty in falling asleep", "Purpose": "Nighttime sleep-aid", "Directions": "adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor children under 12 years of age: do not use", "Do not use": "in children under 12 years of age with any other product containing doxylamine unless you have time for a full night’s sleep", "Other information": "TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at controlled room temperature 20°-25°C (68°-77°F) see end flap for expiration date and lot number", "Inactive ingredients": "dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate", "Questions or comments?": "1-800-632-6900", "Principal Display Panel": "COMPARE TO the active ingredient of UNISOM ® SLEEPTABS ® *See back panel NDC 30142-386-27 Kroger ® Nighttime Sleep-Aid OUR PHARMACIST RECOMMENDED Sleep Aid Doxylamine Succinate Tablets, 25 mg Nighttime Sleep-Aid actual size One Tablet Per Dose 32 TABLETS TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *Unisom ® and SleepTabs ® are registered trademarks of Chattem, Inc., Chattanooga, TN 37409. Chattem, Inc. is not affiliated with The Kroger Co. or this product. DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 FOR MORE PRODUCT INFORMATION, SCAN UPC USING YOUR KROGER APP OR CALL 800-632-6900 50844 REV0123B38627 Our Brands. Our Guarantee. Love It or Your Money Back. www.kroger.com PLEASE RECYCLE Kroger 44-386", "When using this product": "avoid alcoholic beverages do not drive a motor vehicle or operate machinery take only at bedtime", "Stop use and ask a doctor if": "sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of 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 tablet)": "Doxylamine succinate 25 mg", "Ask a doctor before use if you have": "glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland", "Ask a doctor or pharmacist before use if you are": "taking sedatives or any other sleep-aid tranquilizers any other antihistamines any other drugs"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information