FDA Label for Wal-sleep Z Nighttime
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(IN EACH 30 ML DOSE CUP)
- PURPOSE
- USES
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
Wal-sleep Z Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Company. 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(In Each 30 Ml Dose Cup)
Diphenhydramine HCl 50 mg
Purpose
Nighttime sleep-aid
Uses
- for 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
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers.
When Using This Product
avoid alcoholic beverages.
Stop Use And Ask A Doctor If
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a 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 Control Center (1-800-222-1222) right away.
Directions
- do not take more than directed
- mL = milliliter; TBSP = tablespoon; FL OZ = fluid ounce
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- take only one dose per day (24 hours)
- adults and children 12 years and over: take 30 mL (2 TBSP) in the dosing cup provided at bedtime if needed or as directed by a doctor
- children under 12 years: do not use
Other Information
- each 30 mL dose cup contains: sodium 17 mg
- store at 25°C (77F°); excursions permitted between 15°-30°C (59°-86°F)
- use by expiration date on package
Inactive Ingredients
anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sodium chloride, sodium citrate dihydrate, sucralose, sucrose, xanthan gum
Questions Or Comments?
1-800-426-9391
Principal Display Panel
Well at
Walgreens
WALGREENS PHARMACIST RECOMMENDED‡
NDC 0363-0020-02
Wal-Sleep Z®
Diphenhydramine HCl /
Nighttime Sleep Aid
• Non-habit forming
• Alcohol free
NIGHTTIME
12 FL OZ (354 mL) BERRY FLAVOR
Compare to VICKS® ZzzQuil® NIGHTTIME SLEEP-AID active ingredient‡‡
NOT FOR TREATING COLD OR FLU
TAMPER EVIDENT: DO NOT USE IF PRINTED NECK WRAP IS BROKEN OR MISSING
‡Walgreens Pharmacist Survey Study, November 2016.
‡‡This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark VICKS® ZzzQuil® NIGHTTIME SLEEP-AID.
50844 ORG101700202
DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015
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