SLEEP AID- 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:
Strategic Sourcing Services, LLC (Sunmark)
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:
70677-0068-1

SLEEP AID- doxylamine succinate tablet

Strategic Sourcing Services, LLC (Sunmark)

----------

Sunmark 44-386

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Uses

helps to reduce difficulty in falling asleep

Warnings

Do not use

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 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 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

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

dibasic calcium phosphate dihydrate, 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 70677-0068-1

sleep aid

DOXYLAMINE SUCCINATE 25 MG

Nighttime Sleep-Aid

One tablet per dose

EASY TO SWALLOW

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 REV0718A38627

Another Quality Product Distributed by McKesson

One Post Street, San Francisco, CA 94104

Money Back Guarantee

Please visit us at www.sunmarkbrand.com

4 4 - 386

SLEEP AID

doxylamine succinate tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 6 77-0 0 6 8

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

DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)

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

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

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SO DIUM STARCH GLYCO LATE TYPE A PO TATO (UNII: 58 56 J3G2A2)

Product Characteristics

Color

BLUE

S core

no sco re

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:70 6 77-0 0 6 8 -

2 in 1 CARTON

0 4/30 /20 19

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 4/30 /20 19

Labeler -

Strategic Sourcing Services, LLC (Sunmark) (116956644)

Strategic Sourcing Services, LLC (Sunmark)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(70 6 77-0 0 6 8 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(70 6 77-0 0 6 8 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(70 6 77-0 0 6 8 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(70 6 77-0 0 6 8 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(70 6 77-0 0 6 8 )

Revised: 2/2020

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