equate 44-386

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 active Since 2019-07-15

Medication Information

Active Ingredient

Doxylamine succinate 25 mg

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

Other Information

store at controlled room temperature 20°-25°C (68°-77°F)
use by expiration date on package

Inactive Ingredients

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

Description

Doxylamine succinate 25 mg

Principal Display Panel

equate™

NDC 49035-968-27

Compare to

Unisom®

SleepTabs®

active

ingredient*

Sleep-Aid

Doxylamine succinate 25 mg

Nighttime Sleep-Aid

• One Tablet Per Dose

Actual Size

32

TABLETS

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER CAP

IS BROKEN OR MISSING

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

PRODUCT OF ITALY

*This product is not manufactured or distributed by

Chattem, Inc., owner of the registered trademark

Unisom® SleepTabs®. 50844 REV0123B38627

Equate 44-386

Use

helps to reduce difficulty in falling asleep

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

Questions Or Comments?

1-888-287-1915

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.

Ask A Doctor Before Use If You Have

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

Active Ingredient (Active ingredient (in each tablet))

Doxylamine succinate 25 mg

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

Other Information (Other information)

store at controlled room temperature 20°-25°C (68°-77°F)
use by expiration date on package

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel (Principal display panel)

equate™

NDC 49035-968-27

Compare to

Unisom®

SleepTabs®

active

ingredient*

Sleep-Aid

Doxylamine succinate 25 mg

Nighttime Sleep-Aid

• One Tablet Per Dose

Actual Size

32

TABLETS

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED SAFETY SEAL UNDER CAP

IS BROKEN OR MISSING

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

PRODUCT OF ITALY

*This product is not manufactured or distributed by

Chattem, Inc., owner of the registered trademark

Unisom® SleepTabs®. 50844 REV0123B38627

Equate 44-386

Use

helps to reduce difficulty in falling asleep

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

Questions Or Comments? (Questions or comments?)

1-888-287-1915

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.

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

glaucoma
a breathing problem such as asthma, emphysema or chronic bronchitis
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 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": "store at controlled room temperature 20°-25°C (68°-77°F) use by expiration date on package", "Inactive ingredients": "dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate", "Questions or comments?": "1-888-287-1915", "Principal display panel": "equate™ NDC 49035-968-27 Compare to Unisom® SleepTabs® active ingredient* Sleep-Aid Doxylamine succinate 25 mg Nighttime Sleep-Aid • One Tablet Per Dose Actual Size 32 TABLETS TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716 PRODUCT OF ITALY *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®. 50844 REV0123B38627 Equate 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 asthma, emphysema or chronic bronchitis difficulty in urination due to enlargement of the 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