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sleep aid by Rite Aid Corporation

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Rite Aid Corporation
NDC Code: 11822-0189

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.

Rite Aid 44-189

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Use

helps to 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
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • glaucoma

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product
  • avoid alcoholic beverages
  • drowsiness will occur
  • use caution when driving a motor vehicle or operating machinery 

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 (1-800-222-1222) right away.

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

Other information
  • each tablet contains: calcium 60 mg
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN 
  • protect from moisture
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

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

Questions or comments?

1-800-426-9391 

Principal Display Panel

RITE
AID
PHARMACY®

*Compare to the active ingredient in
  Original Formula Sominex®

sleep aid
diphenhydramine HCl 25 mg
nighttime sleep aid

wake up rested
and refreshed              

ACTUAL SIZE 

72 TABLETS       

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 Prestige Brands, Inc., owner of the registered trademark Original Formula Sominex®.
50844         REV0516D18923

DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011

IF YOU'RE NOT SATISFIED, WE'LL HAPPILY REFUND YOUR MONEY.

SATISFACTION
RITE
AID®
GUARANTEE

Rite Aid 44-189

SLEEP AID 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0189
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SILICON DIOXIDE 
STEARIC ACID 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
Product Characteristics
ColorBLUE (light blue) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code44;189
Contains    
Packaging
#Item CodePackage Description
1NDC:11822-0189-39 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 FINALpart33804/10/1990
Labeler - Rite Aid Corporation (014578892)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(11822-0189)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(11822-0189)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(11822-0189)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(11822-0189)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(11822-0189)

 
Rite Aid Corporation

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Medically reviewed on Jul 31, 2018

Further information

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

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