Wal-Sleep Z Diphenhydramine HCl / Sleep Aid: Package Insert and Label Information

WAL-SLEEP Z DIPHENHYDRAMINE HCL / SLEEP AID- diphenhydramine hydrochloride capsule, gelatin coated
Walgreen Company

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.

Drug Facts

Active ingredients (in each liquicap)

Diphenhydramine HCl 25 mg

Purpose

nighttime sleep-aid

Uses

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

Warnings

Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin.
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have

  • a breathing problem such as asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers or any other sleep aid

When using this product

  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

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. Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • take only one dose per day (24 hours) — see Overdose warning
adults & children
12 yrs & over
One dose = TWO 25 mg Softgels (50 mg)
at bed time if needed or as directed by a doctor

Other information

  • store at 20-25° C (68-77° F)
  • avoid excessive heat above 40° C (104° F) and high humidity
  • Protect from light

Inactive ingredients

FD&C blue 1, FD&C red 40, gelatin, glycerin, methylparaben, polyethylene glycol, propylparaben, purified water, sorbitol, titanium dioxide

Questions?

1-866-467-2748

FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES

TAMPER EVIDENT: THIS PACKAGE IS SAFETY SEALED & CHILD RESISTANT. USE ONLY IF BLISTERS ARE INTACT. IF DIFFICULT TO OPEN, USE SCISSORS.

Distributed by: Walgreen Co.

200 Wilmot Rd., Deerfield, IL 60015

PRINCIPAL DISPLAY PANEL

Wal-Sleep Z™ Diphenhydramine HCl / Sleep Aid

Well at Walgreens

Walgreens Pharmacist Recommended

Non-Habit Forming

Alcohol Free

NIGHTTIME

Not for treating Cold or Flu

Compare to ZzzQuil® Liquicaps® active ingredient‡‡

24 SOFTGELS

Wal-Sleep Z 24 Softgels
(click image for full-size original)
WAL-SLEEP Z DIPHENHYDRAMINE HCL / SLEEP AID
diphenhydramine hydrochloride capsule, gelatin coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0060
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diphenhydramine Hydrochloride (Diphenhydramine) Diphenhydramine Hydrochloride 50 mg in 2
Inactive Ingredients
Ingredient Name Strength
FD&C Blue No. 1
FD&C Red No. 40
gelatin
glycerin
METHYLPARABEN
polyethylene glycols
PROPYLPARABEN
water
sorbitol
titanium dioxide
Product Characteristics
Color PURPLE Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code R060
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0060-24 24 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 2 CAPSULE, GELATIN COATED in 1 BLISTER PACK This package is contained within the CARTON (0363-0060-24)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part338 12/08/2011
Labeler — Walgreen Company (008965063)

Revised: 12/2012 Walgreen Company

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