Wal-som
FDA Label NDC 0363-0223

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreen for the product Wal-som (NDC 0363-0223). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, while using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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