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  5. Label Information: Nighttime Sleep Aid Berry Flavor

FDA Label for Nighttime Sleep Aid Berry Flavor

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. PRINCIPAL DISPLAY PANEL

Nighttime Sleep Aid Berry Flavor Product Label

The following document was submitted to the FDA by the labeler of this product Raritan Pharmaceuticals 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.

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 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 or any other sleep- aid.


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.


Overdose Warning:



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


Directions



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

    • adults & children 12yrs & 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 contains: potassium 5 mg, sodium 10 mg
  • ▪store at room temperature

Inactive Ingredients



anhydrous citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, potassium citrate, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum.


Principal Display Panel



DRx CHOICE®

NDC 68163-730-06

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

Sleep-Aid

Nighttime

DIPHENHYDRAMINE HCl

Non-Habit Forming

  •  Makes you fall asleep fast
  •  Alcohol-Free

    • BERRY FLAVOR

    Naturally and Artificially Flavored

    Not for Pain. Not for Colds Just for Sleep.

    6 FL OZ (177 mL)

    $1.99 AMAZING NEW VALUE!

    TAMPER EVIDENT: DO NOT USE IF PRINTED SHRINK BAND IS MISSING OR BROKEN

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

    Manufactured by:

    Raritan Pharmaceuticals

    8 Joanna Court,

    East Brunswick, NJ 08816

    Sleep Aid Nighttime Berry Flavor Diphenhydramine HCl - image 01

    Sleep Aid Nighttime Berry Flavor Diphenhydramine HCl - image 01


* Please review the disclaimer below.