SLEEP AID NIGHTTIME- doxylamine succinate tablet 
McKesson (Health Mart)

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Health Mart 44-386_bisected

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Uses

helps to reduce difficulty in falling asleep

Warnings

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking any other drugs.

When using this product

  • take only at bedtime
  • avoid alcoholic beverages

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 (1-800-222-1222) right away.

Directions

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

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

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

Questions or comments?

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

Principal display panel

Health Mart®

NDC 62011-0344-1

Compare to Unisom®
SleepTabs® active ingredient*

Sleep Aid Tablets

Doxylamine Succinate 25 mg
Nighttime Sleep Aid

Fall Asleep Fast/Safe
One Tablet Per Dose

Easy to Swallow

Actual Size

32 Tablets

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

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®.
50844        REV0513A38627

McKESSON

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Distributed by McKesson
One Post Street, San Francisco, CA 94104
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Health Mart 44-386

Health Mart 44-386

SLEEP AID  NIGHTTIME
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0344
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE25 mg
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;386
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62011-0344-12 in 1 CARTON04/11/200205/20/2022
116 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056404/11/200205/20/2022
Labeler - McKesson (Health Mart) (177667227)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(62011-0344)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(62011-0344)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(62011-0344)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(62011-0344)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(62011-0344)

Revised: 3/2019
Document Id: 6b34b2b1-90a6-4f71-b890-72d488739ba1
Set id: 9c03a879-6b67-486b-b23c-e9d84678a031
Version: 4
Effective Time: 20190313
 
McKesson (Health Mart)