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  5. Label Information: Sleep Aid

FDA Label for Sleep Aid

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS (IN EACH SOFTGEL)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. OTC - ASK DOCTOR/PHARMACIST
    9. WHEN USING THIS PRODUCT
    10. OTC - STOP USE
    11. OTC - PREGNANCY OR BREAST FEEDING
    12. OTC - KEEP OUT OF REACH OF CHILDREN
    13. DIRECTIONS
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. QUESTIONS OR COMMENTS?
    17. OTC - QUESTIONS
    18. PRINCIPAL DISPLAY PANEL

Sleep Aid Product Label

The following document was submitted to the FDA by the labeler of this product Shield Pharmaceuticals Corp. 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 Ingredients (In Each Softgel)



Diphenhydramine HCl 25 mg


Purpose



nighttime sleep-aid


Uses



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

Warnings



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 asthma, emphysema, or chronic bronchitis
  • glaucoma
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you aretaking sedatives, 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

Otc - Stop Use



Stop use and ask a doctor ifsleeplessness persists continuously for more than 2 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: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. 1(800)222-1222


Directions



  • do not take more than directed
  • take only one dose per day (24 hours)
    • adults & children 12 yrs & overtake 2 capsules at bedtime if needed or as directed by a doctor
    children under 12 yearsDo not use


Other Information



  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F) and high humidity
  • Protect from light

Inactive Ingredients



FD&C Blue No. 1, FD&C Red No. 40, gelatin, glycerin, propylene glycol, polyethylene glycol-400, povidone, purified water, sorbitol sorbitan solution


Questions Or Comments?



1-800-373-6981


Otc - Questions



Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788


Principal Display Panel



SLEEP-AID

DIPHENHYDRAMINE HCl 25 mg


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