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:
FRED'S, INC.
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:
55315-986-27

SLEEP AID- doxylamine succinate tablet

FRED'S, INC.

----------

Freds Pharmacy 44-386-Bisect-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

fred's

Pharmacy

NDC 55315-986-27

Compare to the active ingredient in: Unisom SleepTabs

*

Sleep Aid

Doxylamine succinate, 25 mg

Nighttime Sleep-Aid

Fall Asleep Fast / Safe

Easy to Swallow

Actual Bottle Size on Side Panel

Package Contains One Bottle

32 TABLETS

ONE TABLET PER DOSE

Actual Size

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 REV0513E38627

DISTRIBUTED BY: fred's, Inc.

4300 NEW GETWELL RD, MEMPHIS, TN 38118

www.freds inc.com

Freds 4 4 -386

SLEEP AID

doxylamine succinate tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:55315-9 8 6

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 )

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

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

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:55315-9 8 6 -27 2 in 1 CARTON

0 4/11/20 0 2

0 4/30 /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 4/30 /20 22

Labeler -

FRED'S, INC. (005866116)

Establishment

FRED'S, INC.

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

0 38 15446 4

PACK(55315-9 8 6 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 9 4

MANUFACTURE(55315-9 8 6 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 6 8 7340 8 8

PACK(55315-9 8 6 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

8 328 6 78 37

PACK(55315-9 8 6 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

LNK Internatio nal, Inc.

9 6 76 26 30 5

PACK(55315-9 8 6 )

Revised: 9/2019

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