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  5. Label Information: Wal-som

FDA Label for Wal-som

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHILE USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING
    11. KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTION OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Wal-som Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.