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

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

SLEEP-AID
doxylamine succinate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-386
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	25 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)

Product Characteristics
Color	BLUE	Score	2 pieces
Shape	OVAL	Size	10mm
Flavor		Imprint Code	44;386
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 37808-386-27	2 in 1 CARTON	04/11/2002	12/01/2019
1		16 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040564	04/11/2002	12/01/2019

Labeler - H E B (007924756)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	PACK(37808-386)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	MANUFACTURE(37808-386)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	PACK(37808-386)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	PACK(37808-386)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	PACK(37808-386)

Revised: 1/2018

Document Id: 94861f03-69a1-4450-8cc3-b2b1ad2f06e7

Set id: 16f88417-d6cc-47fd-af6c-e916626c1bc3

Version: 4

Effective Time: 20180130

H E B