WAL-SOM  - diphenhydramine hydrochloride tablet 
Walgreen

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.

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Drug facts

Active ingredient

Diphenhydramine HCl 25mg

Purpose

Nighttime Sleep-aid

Uses

For relief of occasional sleeplessness

Warnings


Do not use

  • For 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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

  • Taking sedatives or tranquilizers

While 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 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 center (1-800-222-1222) right away

Directions

Adults and children 12 years of age and over:

Other information

Inactive ingredients

crospovidone, D&C Red No 7 calcium lake, ethyl cellulose, flavor, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified food starch, silicon dioxide, sodium lauryl sulfate, sodium polystyrene sulfonate, sodium starch glycolate, sucralose

Question or comments?

 Call toll free 1--800-walgreens

Principal display panel

NEW

QUICK DISSOLVING

NIGHTTIME SLEEP AID

WELL AT WALGREENS

WALGREENS PHARMACIST RECOMMENDED

WAL-SOM

DIPHENHYDRAMINE HCL TABLETS 25MG

RAPIDMELT/ SLEEP AID

SAFE, NON-HABIT FORMING, FALL ASLEEP FASTER, SLEEP SOUNDLY, WAKE UP REFRESHED

24 QUICK DISSOLVING TABLETS

COMPARE TO UNISOM SLEEPMELTS ACTIVE INGREDIENT

DO NOT SWALLOW WHOLE TABLET

Carton image

WAL-SOM  
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0223
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE (UNII: 68401960MK)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MANNITOL (UNII: 3OWL53L36A)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
Product Characteristics
Colorpink (pink color) Scoreno score
ShapeROUND (Round lozenge shaped) Size14mm
FlavorCHERRY (Cherry flavor) Imprint Code CP223
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0223-024 in 1 CARTON
1NDC:0363-0223-016 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33808/22/2012
Labeler - Walgreen (008965063)
Registrant - Capricorn Pharma Inc. (041704524)
Establishment
NameAddressID/FEIBusiness Operations
Capricorn Pharma Inc.041704524manufacture(0363-0223) , analysis(0363-0223) , pack(0363-0223) , label(0363-0223)

Revised: 8/2012
Document Id: 14c0e8e3-f36f-4b10-8f76-2079600ca6f4
Set id: 21f18921-e0d7-42ad-8a62-e912711aa8a3
Version: 1
Effective Time: 20120822
 
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