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  5. Label Information: Maximum Strength Nighttime Sleep-aid

FDA Label for Maximum Strength Nighttime Sleep-aid

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    4. USES
    5. WARNINS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. ASK YOUR 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. KEEP OUT OF REACH OF CHILDERN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS OR COMMENTS?
    16. MAXIMUM STRENGTH NIGHTTIME SLEEP-AIDDIPHENHYDRAMINE HCL 50MG / NIGHTTIME SLEEP-AID16  SOFTGELS

Maximum Strength Nighttime Sleep-aid Product Label

The following document was submitted to the FDA by the labeler of this product Healthlife Of Usa. 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.

Drug Facts



Maximum Strength Nighttime Sleep-Aid


Purpose



Nighttime Sleep-Aid


Active Ingredient (In Each Softgel)



Diphenhydramine HCL 50mg 


Uses



  • Relief of occasional sleeplessness

Warnins



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 antihistamine and nighttime cold/flu products

Ask A Doctor Before Use If You Have



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

Ask Your Doctor Or Pharmacist Before Use If You Are



  • taking sedative or tranquilizers or any other sleep-aid.

When Using This Product



  • drowsiness will occur
  • avoid alcoholic beverages and other drugs that cause drowsiness
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery 

Stop Use And Ask A Doctor If



  • sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Childern.



Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any sighs or symptoms.


Directions



  • Do not take more than directed (see overdosage warning) 
  • Adults and children 12 years and over: Take 1 softgel at bedtime if needed or as directed by a doctor
  • Children under 12 years of age: Do not use

Other Information



  • Store at 15°-30°C (59°-86°F)
  • Read all product information before using 
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive Ingredients



  • FD&C Blue#1
  • Gelatin
  • Glycerin
  • Polyethylene glycol
  • Polyvinyl acetate phthalate
  • Polyvinyl glycol
  • Sorbitol
  • Titanium Dioxide
  • Water

Questions Or Comments?



Call toll free 1-844-832-1138 Monday through Friday 9AM -5PM EST or www.healthlifeofusa.com


Maximum Strength Nighttime Sleep-Aiddiphenhydramine Hcl 50Mg / Nighttime Sleep-Aid16  Softgels



afe & Non-Habit Forming
Get to sleep Fast
Sleep Soundly
Wake Refreshed

Compare to Unisom® Sleepgels® active ingredients

Distributed by:

Healthlife of USA LLC
Rahway
NJ 07065
www.healthlifeofusa.com


* Please review the disclaimer below.