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Somnitabs by GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

Medically reviewed on May 22, 2018

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
NDC Code: 64092-010

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Healthcare 44-189

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime Sleep-Aid

Uses

helps reduce difficulty falling asleep

Warnings

Do not use
  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers. 

When using this product

avoid alcoholic drinks. 

Stop use and ask a doctor if
  • sleeplessness persists continuously for more than 2 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 right away. 

Directions
  • adults and children 12 years and older: take 2 tablets at bedtime if needed or as directed by a doctor
  • children under 12 years: do not use

Other information
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid

Principal Display Panel

HEALTHCARE

NDC 64092-010-16

*Compare to the active
ingredient in Sominex®

Somnitabs
Nighttime Sleep Aid

with Diphenhydramine HCl 25 mg

An Aid to Sleep

16 TABLETS

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

*This product is not manufactured or distributed
by GlaxoSmithKline Consumer Healthcare, owner
of the registered trademark Sominex®.
50844      REV0412B18921

Distributed by: Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E., Grand Rapids, MI 49512
www.glwholesale.com

HEALTHCARE GUARANTEE
If you are not completely satisfied with this
product, regardless of reason, return your unused
portion to Great Lakes Wholesale for a full refund

Healthcare 44-189

SOMNITABS 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-010
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
STEARIC ACID 
Product Characteristics
ColorBLUEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;189
Contains    
Packaging
#Item CodePackage Description
1NDC:64092-010-162 BLISTER PACK in 1 CARTON
18 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33812/25/1992
Labeler - GREAT LAKES WHOLESALE, MARKETING, & SALES, INC. (361925498)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(64092-010)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(64092-010)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(64092-010)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(64092-010)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(64092-010)

 
GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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