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  5. Label Information: Rite Aid Nighttime Sleep Aid Non Habit Forming

FDA Label for Rite Aid Nighttime Sleep Aid Non Habit Forming

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. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. PRINCIPAL DISPLAY PANEL

Rite Aid Nighttime Sleep Aid Non Habit Forming Product Label

The following document was submitted to the FDA by the labeler of this product Rite Aid Corporation. 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

In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.


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 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 are taking sedatives or tranquilizers


When Using This Product



  • ▪avoid alcoholic beverages

Otc - Stop Use



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.


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.


Directions



  • ▪take only one dose per day (24 hours)
  • ▪measure with dosing cup provided
    • adults & children 12 yrs & over30 mL at bed time if needed or as directed by a doctorchildren under 12 yrsdo not use
     
     
     
     

Other Information



  • ▪each 30 mL dose contains: sodium 10 mg
  • ▪store at room temperature

Inactive Ingredients



anhydrous citric acid, 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# 11822-7530-1

Nighttime

Sleep-aid

Diphenhydramine HCl

Non-Habit Forming

Makes you fall asleep fast

Sugar-Free,

  • •Dye-Free,
  •  Aspartame-Free

    • Berry Flavor

    Naturally and Artificially Flavored

    No added alcohol

    Not for Pain. Not for Colds. Just for Sleep

    12 FL. OZ. (354 mL)

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

    Distributed by

    Riteaid nighttime sleep aid Diphenhydramine HCl - image 01

    Riteaid nighttime sleep aid Diphenhydramine HCl - image 01


* Please review the disclaimer below.