SLEEP AID NIGHTTIME- doxylamine succinate tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)
Available from:
McKesson (Health Mart)
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Nighttime sleep-aid helps to reduce difficulty in falling asleep
Authorization status:
Abbreviated New Drug Application
Authorization number:
62011-0344-1

SLEEP AID NIGHTTIME- doxylamine succinate tablet

McKesson (Health Mart)

----------

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

Another Quality Product

Distributed by McKesson

One Post Street, San Francisco, CA 94104

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healthmart.com

Health Mart 4 4 -386

SLEEP AID NIGHTTIME

doxylamine succinate tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 20 11-0 344

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DO XYLAMINE SUCCINATE (UNII: V9 BI9 B5YI2) (DOXYLAMINE - UNII:9 5QB77JKPL)

DOXYLAMINE SUCCINATE

25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

ANHYDRO US DIBASIC CALCIUM PHO SPHATE (UNII: L11K75P9 2J)

Product Characteristics

Color

BLUE

S core

2 pieces

S hap e

OVAL

S iz e

10 mm

Flavor

Imprint Code

44;38 6

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 20 11-0 344-1 2 in 1 CARTON

0 4/11/20 0 2

0 5/20 /20 22

1

16 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 56 4

0 4/11/20 0 2

0 5/20 /20 22

Labeler -

McKesson (Health Mart) (177667227)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

McKesson (Health Mart)

LNK Internatio nal, Inc.

0 38 15446 4

PACK(6 20 11-0 344)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(6 20 11-0 344)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(6 20 11-0 344)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(6 20 11-0 344)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(6 20 11-0 344)

Revised: 3/2019

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