WAL-SOM- diphenhydramine hydrochloride tablet

Wal-Som by

Drug Labeling and Warnings

Wal-Som by is a Otc medication manufactured, distributed, or labeled by Walgreen , Capricorn Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• 2 Rapidmelt (25mg each) at bedtime if needed, or as directed by a doctor
• Place 2 tablets on to tongue; tablets dissolve with or without water
• allow tablets to dissolve in mouth or chew before swallowing

Other information

• Each tablet contains Sodium 5mg
• Do not use if carton is opened or blister unit is broken
• Store between 20-25 °C(68-77°F). Avoid high humidity. Protect from light.
• See side panel for lot number and expiration date

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

INGREDIENTS AND APPEARANCE

WAL-SOM  
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0223
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink (pink color)	Score	no score
Shape	ROUND (Round lozenge shaped)	Size	14mm
Flavor	CHERRY (Cherry flavor)	Imprint Code	CP223
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0223-02	4 in 1 CARTON
1	NDC: 0363-0223-01	6 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part338	08/22/2012

Labeler - Walgreen (008965063)

Registrant - Capricorn Pharma Inc. (041704524)

Establishment
Name	Address	ID/FEI	Business Operations
Capricorn Pharma Inc.		041704524	manufacture(0363-0223) , analysis(0363-0223) , pack(0363-0223) , label(0363-0223)