NIGHTTIME SLEEP AID- doxylamine succinate tablet 
Safeway

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Safeway 44-386

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

Other information

Inactive ingredients

dicalcium phosphate, FD&C blue #1 aluminum lake, magnesiums 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

NDC 21130-326-01

Compare to Unisom® SleepTabs® active ingredient*

Nighttime
Sleep Aid
Doxylamine Succinate Tablets, 5 mg
Nighttime Sleep-Aid
• Safe. Proven Effective.
• Contains No Pain Reliever
• Just One Tablet Per Dose

32 TABLETS

SAFEWAY®

*this product is not manufactured or distributed by Chattem, Inc., distributors of the registered trademark Unisom® SleepTabs®.
50844     REV0512B38627

DISTRIBUTED BY SAFEWAY INC., P.O. BOX 99, PLEASANTON, CA 94566-009
1-888-SAFEWAY / www.safeway.com

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

Safeway 44-386

Safeway 44-386

NIGHTTIME SLEEP AID 
doxylamine succinate tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:21130-386
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
Color BLUE Score 2 pieces
Shape CAPSULE Size 10mm
Flavor Imprint Code 33;386
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:21130-386-27 4 in 1 CARTON
1 8 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040564 04/11/2002
Labeler - Safeway (009137209)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(21130-386)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(21130-386)

Revised: 9/2013
Document Id: 6f3a24b6-9cb2-4a94-96bc-f0501641cb23
Set id: c7dea3ea-c9f5-4903-859b-3b7a3762f07e
Version: 2
Effective Time: 20130918
 
Safeway