FDA Label for Meijer Nighttime Sleep-aid Berry Flavor

View Indications, Usage & Precautions

Meijer Nighttime Sleep-aid Berry Flavor Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution Inc. 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.

Drug Facts



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

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 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 two 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: 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)
  • ▪measure with dosing cup provide
  • adults & children 12 yrs & over

    One Dose = 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 contains: sodium 23 mg
    • •store at room temperature
    • •protect from light. Does not meet USP requirement for light-resistant packaging.

Inactive Ingredients



anhydrous citric acid, FD&C Blue #1, FD&C Red #40, glycerin, natural and artificial flavor, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.


Questions Or Comments?



1-866-467-2748


Package Label-Principal Display Panel 12 Fl Oz (354 Ml Bottle)



meijer®
NDC# 41250-738-12
Compare to Zzzquil® Nighttime Sleep-Aid* active ingredient*

NighttimeSleep-aid

Diphenhydramine HCl 50 mg

  • •Non-Habit Forming
  • Alcohol-Free

    Not for treating Cold or Flu, See Warnings

    Berry Flavor

    Naturally and Artificially Flavored

    12 FL OZ (354 mL)

    MEIJER PHARMACIST RECOMMENED

    MONEY BACK GURANTEE

    DIST. BY MEIJER DISTRIBUTION, INC.

    GRAND RAPIDS, MI 49544

    www.meijer.com

    *This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark ZzzQuil®.


* Please review the disclaimer below.