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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 INGREDIENT(S)
    2. PURPOSE
    3. USE(S)
    4. WARNINGS
    5. DO NOT USE
    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 DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN
    12. OVERDOSE WARNING
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. PRINCIPAL DISPLAY PANEL

Nighttime Sleep-aid Product Label

The following document was submitted to the FDA by the labeler of this product Guardian Drug 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.

Active Ingredient(S)



Diphenhydramine HCl 50 mg


Purpose



Nighttime sleep-aid


Use(S)



  • for relief of occasional sleeplessness
  • helps you 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
  • with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

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
  • heart disease


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 and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

Stop Use And Ask Doctor If



sleepleness 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



Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away.


Directions



  • take only one dose per day (24 hours) - see Overdose warning
  • only use dosage cup that is included with this product for accurate dosing
  • mL = millilitere; Tbsp = teblespoons


    • Age 
    Dose 
     adults & chlidren 12 year & over one = 30 mL (2Tbsp) at bedtime if needed or as directed by a doctor
     childrens under 12 years do not use


Other Information



  • each 30 mL (2 Tbsp) contain: sodium 30 mg
  • store at room temperature
  • protect from light

Inactive Ingredients



citric acid, FD&C Blue # 1, FD&C Red # 40, flavors, high fructose corn syrup, polyoxyl 40 stearate, purified water, saccharine sodium, sodium benzoate, sodium citrate.


Principal Display Panel



NDC 53041-633-58

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


Nighttime Sleep-Aid

Warming Berry Flavor

Relieves:

Occasional Sleeplessness


6 FL OZ (177 ML)


gdc-633-6oz - gdc 633 6oz

gdc-633-6oz - gdc 633 6oz


* Please review the disclaimer below.