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  5. Label Information: Kroger Nighttime Sleep-aid

FDA Label for Kroger Nighttime Sleep-aid

View Indications, Usage & Precautions

Table of Contents

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

Kroger Nighttime Sleep-aid 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.

Other



Drug Facts


Active Ingredient (In Each 30 Ml Dose Cup)



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 asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers.


When Using This Product



  • avoid alcoholic beverages

Otc - Stop Use



Stop use and ask a doctor ifsleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.


Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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.1-800-222-1222


Directions



  • take only one dose per day (24 hours)
  • Only use 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 dose cup contains: potassium 5 mg; sodium 10 mg
  • store at room temperature

Inactive Ingredients



anhydrous citric acid, FD&C blue 1, FD&C red 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.


Questions Or Comments?



1-866-467-2748


Principal Display Panel



Compare to the active ingredient in ZzzQuil™ Nighttime Sleep-Aid*

NDC 41226-730-12

Nighttime

Sleep-Aid

Diphenhydramine HCl

  • Non-habit forming
  • Makes you fall asleep fast

    • Berry Flavor

    Naturally & artificially flavored

    No added alcohol

    Not for pain. Not for Colds.

    Just for Sleep

    12 FL. OZ. (354 mL)

    TAMPER EVIDENT:Do not use if printed shrink band is missing or broken

    *This product is not manufactured or distributed by Proctor & Gamble, the distributor of ZzzQuil™ Nighttime Sleep-Aid.

    Distributed by:

    KROGER Nighttime Sleep Aid Berry Flavor 12 FL OZ - image 01

    KROGER Nighttime Sleep Aid Berry Flavor 12 FL OZ - image 01


* Please review the disclaimer below.