FDA Label for Sleep Aid Nighttime
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 30 ML)
- 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?
- PRINCIPAL DISPLAY PANEL
- PACKAGE LABEL
Sleep Aid Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product Winco Foods, Llc. 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)
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
- with any other product containing diphenhydramine, even one used on the skin
- for children under 12 years of age
- with other drugs that cause drowsiness such as antihistamines, nighttime cold/flu products, and other nighttime sleep-aids
Ask A Doctor Before Use If You Have
- a breathing problem such as asthma, emphysema, or chronic bronchitis
- glaucoma
- heart disease
- trouble urinating due to an enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use If You Are
taking sedatives or tranquilizers or any other sleep-aid.
When Using This Product
- drowsiness will occur
- avoid alcoholic beverages and other drugs that cause drowsiness
- 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)
- mL= milliliter
- keep dosing cup with product
- measure only with dosing cup provided do not use any other dosing device
- adults and children 12 years and over
- one dose=30 mL at bedtime if needed, or as directed by a doctor
- children under 12 years do not use
Other Information
- each 30 mL contains: sodium 23 mg
- store at 20-25°C (68-77°F)
- do not refrigerate
- protect from light
Inactive Ingredients
citric acid, ethyl alcohol, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyoxyl 40 stearate, propylene glycol, purified water, saccharin sodium , sodium benzoate, trisodium citrate dihydrate
Questions?
Or to report an adverse event call 800-824-1706 Monday - Friday 9am - 4PM MST
Principal Display Panel
*Compare to the active igredient in ZZZQUIL®
NIGHTTIME
Sleep Aid
DIPHENHYDRAMINE HCI 50 mg / NIGHTTIME SLEEP-AID
Not For Treating Cold or Flu
Safe, Non-Habit Forming
Alcohol 10%
Berry Flavor
FL OZ (mL)
FAILURE TO FOLLOW THESE WARNINGS COULD RESULT IN SERIOUS CONSEQUENCES
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed byThe Procter & Gamble Company. ZZZQUIL® is a registered trademark of The Procter & Gamble Company.
DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704
Package Label
Winco Foods NightTime Sleep-Aid Berry Flavor
* Please review the disclaimer below.