Sleep-Aid by H E B / LNK International, Inc. HEB 44-386-Delisted

Sleep-Aid by

Drug Labeling and Warnings

Sleep-Aid by is a Otc medication manufactured, distributed, or labeled by H E B, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SLEEP-AID- doxylamine succinate tablet 
H E B

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HEB 44-386-Delisted

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Use

helps to reduce difficulty in falling asleep

Warnings

Ask a doctor before use if you have

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

  • avoid alcoholic beverages
  • 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 (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 20º-25ºC (68º-77ºF)
  • 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

Compare to Unisom® SleepTabs® active ingredient*

NDC: 37808-386-27

H - E - B ®

S L E E P  -  A I D
Doxylamine Succinate Tablets, 25 mg

NIghttime Sleep-Aid
Proven Effective
Just One Tablet Per Dose

Does Not Contain Gluten

ACTUAL SIZE

32 Tablets

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepTabs®.
50844    REV0513A38627     1309

MADE WITH PRIDE AND CARE FOR H-E-B®, SAN ANTONIO, TX 78204

GUARANTEE
We believe the high quality of this H-E-B® product makes it an outstanding value. We hope you'll agree. If not, we'll cheerfully refund your money. Thanks for shopping with us.

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

HEB 44-386

HEB 44-386

SLEEP-AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 37808-386
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)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
Product Characteristics
ColorBLUEScore2 pieces
ShapeOVALSize10mm
FlavorImprint Code 44;386
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 37808-386-272 in 1 CARTON04/11/200212/01/2019
116 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056404/11/200212/01/2019
Labeler - H E B (007924756)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(37808-386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(37808-386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(37808-386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(37808-386)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(37808-386)

Revised: 1/2018
 
H E B