Equate 44-386

Equate 44-386
SPL v11
SPL
SPL Set ID 71e0cef1-6195-4b67-9c1f-b4e5fbeae53c
Route
ORAL
Published
Effective Date 2025-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

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
Description

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

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
  • 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

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)
  • 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

Questions Or Comments? (Questions or comments?)

1-888-287-1915

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


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 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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:06.458192 · Updated: 2026-03-14T23:08:40.140455