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  5. Label Information: Exchange Select Sleeptime

FDA Label for Exchange Select Sleeptime

View Indications, Usage & Precautions

Table of Contents

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

Exchange Select Sleeptime Product Label

The following document was submitted to the FDA by the labeler of this product Army & Air Force Exchange Service. 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 (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

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

Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers


When Using This Product



avoid alcoholic beverages


Stop Use And Ask A Doctor If



sleeplessness persists continuously for more than 2 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.



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


Directions



  • •take only one dose per day (24 hours)
    • adults & children 12 yrs & overchildren under 12 yrs
     

    2 softgels at bedtime if needed or as directed by a doctor

     

    do not use


Other Information



  • •store at 20-25°C (68-77°F)
  • •avoid excessive heat above 40oC (104oF)
  • •protect from light

Inactive Ingredients



edible ink, FD&C blue #1, FD&C red #40, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution


Questions Or Comments?



1-800-719-9260


Package/Label Principal Display Panel



exchange select™

Compare to the active ingredient of ZzzQuil®

sleeptime

Diphenhydramine HCl 25 mg

NIGHTTIME SLEEP-AID

Non-Habit Forming

Not for treating Cold or Flu

Actual Size

See Warnings

12 SOFTGELS

quality value

sleeptime-image - image 01

sleeptime-image - image 01


* Please review the disclaimer below.