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  5. Label Information: Ez Nite Sleep

FDA Label for Ez Nite Sleep

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - ASK DOCTOR/PHARMACIST
    9. OTC - WHEN USING
    10. OTC - STOP USE
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. OTC - QUESTIONS
    17. PRINCIPAL DISPLAY PANEL

Ez Nite Sleep Product Label

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

Other



Drug Facts

Drug Facts (continued)

Drug Facts (continued)


Active Ingredient (In Each Softgel)



Diphenhydramine HCl 25mg


Purpose



Nighttime sleep-aid


Uses



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

Warnings



Warnings


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 prostate gland

Otc - Ask Doctor/Pharmacist



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


Otc - When Using



When using this product 

  • avoid alcoholic beverages

Otc - Stop Use



Stop use and ask a doctor if sleeplessness persists continously for more than 2 weeks. Insomnia may be a symptom be a symptom of serious underlying medical illness.


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In care of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • take only one dose per day (24 hours)
    •  adults & children 12 years & over    One dose= TWO 25 mg softgels (50 mg) at bed time if needed or as directed by a doctor
     children under 12 years    Do not use


Other Information



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

Inactive Ingredients



FD&C Blue#1, FD&C Red#40, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide


Otc - Questions



Questions or comments? 1-800-632-6900


Principal Display Panel



COMPARE TO the active ingredient of ZZZQUIL® *see side panel

NDC 30142-224-24

Kroger®

Nighttime Sleep-Aid

EZ Nite Sleep

Diphenhydramine HCL 25 mg

Helps Reduce Difficulty Faling Asleep

actual size

Non-Habit Forming

Not fro Treating Cold or Flu- See Warnings

24 SOFTGELS

*Zzzquil® is a registered trademark of The Procter & Gamble Company, Cincinnati, OH 45202. The Procter & Gamble Comopany is not affiliated with The Kroger Co. ir this product.


* Please review the disclaimer below.