Dye Free Wal Sleep Z Liquid
FDA Label NDC 0363-0753

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 Co. for the product Dye Free Wal Sleep Z (NDC 0363-0753). 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 other, active ingredient (in each 30 ml), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

Active Ingredient (In Each 30 Ml)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Uses

  • for the relief of occasional sleeplessness
  • reduces time to fall asleep if you have difficulty falling asleep

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
  • difficulty in urination due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When Using This Product

  • avoid alcoholic beverages

Otc - Stop Use

Stop use and ask a doctor if sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

  • take only one dose per day (24 hours)
  • measure with dosing cup provided
    • adults & children 12 yrs & overOne Dose = 30 mL at bed time if needed or as directed by a doctorChildren under 12 yrsdo not use
     
     
     
     

Other Information

  • each 30 mL dose contains: sodium 23 mg
  • store at room temperature
  • protect from light. Does not meet USP requirements for light-resistant packaging

Inactive Ingredients

anhydrous citric acid, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.

Questions Or Comments?

1-866-467-2748

Principal Display Panel

Walgreens

Compare to Vicks® ZzzQuil® Nighttime Sleep-Aid active ingredient ††

NDC 0363-0753-12

Dye –Free

Wal-Sleep Z®

Diphenhydramine HCl / Nighttime Sleep Aid

DYE FREE

SUGAR FREE

  • Non – habit forming

    • BERRY FLAVOR

    12 FL OZ (354 mL)

    NOT FOR TREATING COLD OR FLU,SEE WARNINGS.

    FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

    Walgreens Pharmacist Recommended

    Walgreens Pharmacist Survey

    †† This product is not manufactured or distributed by Procter & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMONT RD, DEERFIELD, IL 60015

    100% SATISFACTION GUARANTEED

    Walgreens.com ©2018 Walgreen Co.

    Walgreens Dye Free Wal- Sleep Z Berry Flavor 12 Fl Oz (Image 01)

    Walgreens Dye Free Wal- Sleep Z Berry Flavor 12 Fl Oz (Image 01)

* Please review the disclaimer below.