Wal-Som: Package Insert and Label Information

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.

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

Carton image
(click image for full-size original)
WAL-SOM
diphenhydramine hydrochloride tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0223
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
D&C RED NO. 7
ETHYLCELLULOSES
MAGNESIUM STEARATE
MALTODEXTRIN
MANNITOL
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
SODIUM POLYSTYRENE SULFONATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SUCRALOSE
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)
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 Multilevel Packaging
1 NDC:0363-0223-02 4 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK (0363-0223-01)
1 NDC:0363-0223-01 6 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (0363-0223-02)
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 Operations
Capricorn Pharma Inc. 041704524 manufacture (0363-0223), analysis (0363-0223), pack (0363-0223), label (0363-0223)

Revised: 08/2012 Walgreen

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