MedPath

Sleep Aid

Exchange Select 44-386

Approved
Approval ID

009df4c9-a524-4b8f-be7a-52c521e68ff1

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 23, 2025

Manufacturers
FDA

ARMY AND AIR FORCE EXCHANGE SERVICE

DUNS: 001695568

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Doxylamine Succinate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code55301-986
Application NumberANDA040564
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxylamine Succinate
Product Specifications
Route of AdministrationORAL
Effective DateMay 23, 2025
FDA Product Classification

INGREDIENTS (6)

DOXYLAMINE SUCCINATEActive
Quantity: 25 mg in 1 1
Code: V9BI9B5YI2
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/23/2025

Principal display panel

exchange Select™

Compare To The Active Ingredient of
Unisom® SleepTabs®*

Sleep Aid
Doxylamine succinate tablet, 25 mg

Nighttime
Sleep-Aid

• Helps with falling asleep
• One tablet per dose

Actual Size

32 TABLETS

quality
value

*This product is not manufactured or distributed by Chattem, Inc.,
owner of the registered trademark Unisom® SleepTabs®.
50844 REV0123C38627

“SATISFACTION GUARANTEED OR YOUR MONEY BACK”
Manufactured For Your Military Exchanges
Distributed by: LNK International, Inc.,
Hauppauge, NY 11788
1-800-426-9391

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED
OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY
SIGNS OF TAMPERING

![Exchange Select 44-386](/dailymed/image.cfm?name=exchange- select-44-386-1.jpg&id=876780)

Exchange Select 44-386

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/23/2025

Use

  • helps to reduce difficulty in falling asleep

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/23/2025

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 INGREDIENT SECTION

LOINC: 51727-6Updated: 5/23/2025

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 5/23/2025

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/23/2025

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/23/2025

Purpose

Nighttime sleep-aid

WARNINGS SECTION

LOINC: 34071-1Updated: 5/23/2025

Warnings

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

Ask a doctor before use if you have

  • a breathing problem such as asthma, emphysema or chronic bronchitis

  • difficulty in urination due to enlargement of the prostate gland

  • glaucoma

Ask a doctor or pharmacist before use if you are

taking

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

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 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/23/2025

Directions

  • adults and children 12 years and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor

  • children under 12 years: do not use

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Sleep Aid - FDA Drug Approval Details