SLEEP AID- doxylamine succinate tablet 
United Natural Foods, Inc. dba UNFI

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Equaline 44-386

Active ingredient (in each tablet)

Doxylamine succinate 25 mg

Purpose

Nighttime sleep-aid

Use

Warnings

Do not use

  • in children under 12 years of age
  • with any other product containing doxylamine
  • unless you have time for a full night’s sleep

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking

  • sedatives or any other sleep-aid
  • tranquilizers
  • any other antihistamines
  • any other drugs

When using this product

  • avoid alcoholic beverages
  • do not drive a motor vehicle or operate machinery
  • 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 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 right away.

Directions

Other information

Inactive ingredients

dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions or comments?

Call 1-855-423-2630 Mon-Fri 8 am to 6 pm CST

Principal display panel

EQUALINE®

compare to
Unisom® SleepTabs®

active ingredient*

NDC 41163-986-22

nighttime
sleep aid

doxylamine succinate tablets, 25 mg
(nighttime sleep aid)

• just one tablet per dose

48 mini tablets

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     REV0123D38622

DISTRIBUTED BY UNFI
PROVIDENCE, RI 02908 USA
855-423-2630

100% Quality
GUARANTEED

Equaline 44-386

Equaline 44-386

SLEEP AID 
doxylamine succinate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-986
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE25 mg
Inactive Ingredients
Ingredient NameStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorblueScoreno score
ShapeOVALSize10mm
FlavorImprint Code 44;386
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41163-986-223 in 1 CARTON06/30/2019
116 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04056406/30/2019
Labeler - United Natural Foods, Inc. dba UNFI (943556183)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464pack(41163-986)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837manufacture(41163-986) , pack(41163-986)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305pack(41163-986)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.117025878manufacture(41163-986)

Revised: 4/2024
Document Id: c089e726-ada4-4965-b350-48cbe913594b
Set id: 005b5ad8-d762-46b5-a7a5-e0ff11ba936a
Version: 7
Effective Time: 20240426
 
United Natural Foods, Inc. dba UNFI