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  5. Label Information: Nighttime Sleep-aid

FDA Label for Nighttime Sleep-aid

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTSDRUG FACTS(IN EACH 30 ML DOSE CUP OR 2 TABLESPOONS)
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST FEEDING
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. DIRECTIONS
    15. PRODUCT LABEL

Nighttime Sleep-aid Product Label

The following document was submitted to the FDA by the labeler of this product Demoulas Market Basket. 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.

Active Ingredientsdrug Facts(In Each 30 Ml Dose Cup Or 2 Tablespoons)



Diphenhydramine HCL 50 mg


Purpose



Nighttime sleep-aid


Keep Out Of Reach Of Children



Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.


Uses



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

Warnings



Do not use

  • for children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin
  • with any other drugs that cause drowsiness such as antihistamines and nighttime cough, cold/flu products

Ask A Doctor Before Use If You Have



  • heart disease
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as asthma, emphysema or chronic bronchitis

Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers or any other sleep aid


When Using This Product



  • do not use more than directed
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop Use And Ask A Doctor If



  • sleepiness persists continuously for more than two weeks. Insomnia may be a symptom of a serious underlying medical illness.

If Pregnant Or Breast Feeding



ask a health professional before use.


Other Information



  • each 30 mL dose (2 tablespoons) contains: sodium 23 mg
    • dosage cup provided
    • store at room temperature

Inactive Ingredients



citric acid, FD and C Blue # 1, FD and C Red # 40, flavor, high fructose corn syrup, poloxamer 407, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin


Questions?



Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944


Directions



  • take only as recommended
  • use dosage cup or tablespoon

    • Age                                                              Dose
    Adults and children 12 years and over             One dose = 2 tablespoons (30 mL) at bedtime if needed or as directed by a doctor


Product Label



*COMPARE TO THE ACTIVE INGREDIENT IN ZzzQuil™ NIGHTTIME SLEEP-AID

Nighttime

SLEEP-AID

Diphenhydramine

Non-Habit Forming

Warming Berry Flavored Liquid

No for treating Cold or Flu

12 FL OZ (354 mL)

*This product is not manufactured or distributed by Proctor and Gamble, owner of the registered trademark ZzzQuil™ .

DISTRIBUTED BY DEMOULAS SUPERMARKETS INC.

875 EAST STREET

TEWKSBURY, MA 01876

LR-053 Rev 01

DO NOT USE IF IMPRINT SHRINK BAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences


* Please review the disclaimer below.