1. Home
  2. Labeler Index
  3. Kroger Company
  4. 30142-549
  5. Label Information: Ez Nite Sleep

FDA Label for Ez Nite Sleep

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 30 ML)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Ez Nite Sleep Product Label

The following document was submitted to the FDA by the labeler of this product Kroger 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)



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

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 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 right away (1-800-222-1222).


Directions



  • •take only one dose per day (24 hours)
  • •only use the dose cup provided

    • adults & children 12 yrs & over

    30 mL at bed time if needed or as directed by a doctor

    children under 12 yrs

    do not use


Other Information



  • •each 30 mL contains: sodium 20 mg
  • •store at 20-25°C (68-77°F)

Inactive Ingredients



alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate


Questions Or Comments?



1-800-632-6900


Package/Label Principal Display Panel



COMPARE TO the active ingredient of VICKS® ZZZQUIL® See back panel

OUR PHARMACIST RECOMMENDED

Nighttime Sleep-Aid

EZ Nite Sleep

Helps You Fall Asleep

Diphenhydramine HCl 50mg per 30mL

10% ALCOHOL

Not for Treating Cold or Flu

Non-Habit Forming

Berry Flavor

6 FL OZ (177mL)


* Please review the disclaimer below.