Your browser does not support JavaScript! SLEEP-AID (DIPHENHYDRAMINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE]
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SLEEP-AID (diphenhydramine hcl) tablet
[ARMY AND AIR FORCE EXCHANGE SERVICE]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

  • see end flap for expiration date and lot number
  • store at controlled room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

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

Questions or comments?

1-800-426-9391

Principal Display Panel

exchange select™

Compare to The Active Ingredient of Sominex®*

SLEEP AID
DIPHENHYDRAMINE HCl 25 mg
NIGHTTIME SLEEP-AID

Wake Up Rested and Refreshed
Doctor preferred sleep ingredient

72 TABLETS

*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare, owner of the registered trademark Sominex®.
50844        REV010E18923

SATISFACTION GUARANTEED OR YOUR MONEY BACK
Manufactured For: Your Military Exchanges
by: LNK International, Inc.
Hauppauge, NY 11788

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

Exchange Select 44-189

Exchange Select 44-189

SLEEP-AID 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55301-189
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 
Product Characteristics
ColorBLUEScore2 pieces
ShapeROUNDSize10mm
FlavorImprint Code 44;189
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55301-189-231 in 1 CARTON
172 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/25/1992
Labeler - ARMY AND AIR FORCE EXCHANGE SERVICE (001695568)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(55301-189)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(55301-189)

Revised: 6/2013
 
ARMY AND AIR FORCE EXCHANGE SERVICE

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