1. Home
  2. Labeler Index
  3. Healthlife Of Usa
  4. 69517-124
  5. Label Information: Gentle Relief Stool Softner

FDA Label for Gentle Relief Stool Softner

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    4. USES
    5. WARNINGS
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. GENTLE RELIEFSTOOL SOFTNERDOCUSATE SODIUM 100MGGENTLE AND EASY RELIEF OF CONSTIPATION24 SOFTGELSDISTRIBUTED BY:HEALTHLIFE OF USA LLCRAHWAYNJ 07065WWW.HEALTHLIFEOFUSA.COM

Gentle Relief Stool Softner 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



Gentle Relief Stool Softner


Purpose



Stool Softner


Active Ingredient (In Each Softgel)



Docusate sodium 100mg


Uses



  • For prevention of dry, hard stools
  • For relief of occasional constipation.

    • This product generally produces a bowel movement within 12 to 72 hours


Warnings



Do not use

  • If you are presently taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea, or vomiting are present
  • For longer than 1 week, unless directed by a doctor

Ask A Doctor Before Use If You Have



Noticed a sudden change in bowel habits that continues over a period of 2 weeks


Stop Use And Ask A Doctor If



  • You have rectal bleeding 
  • you fail to have a bowel movement after use

If Pregnant Or Breast-Feeding



Ask a health professional before use.


Keep Out Of Reach Of Children



Overdose warning: In case of overdosage, get medical help or contact a Poison Control Center right away.


Directions



  • Take with a glass of water
  • Adults and children 12 years of age and over: Take 1 to 3 softgels daily. This dose may be taken as single daily dose or in divided doses
  • Children 2 to under 12 years of age: Take 1 softgel daily
  • Children under 2 years of age: Consult a physician

Other Information



Each softgel contains sodium 6 mg
Store at controlled room temperature 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 Red # 40
  • FD&C Yellow # 6
  • Gelatin
  • Glycerin
  • Polyethylene glycol 400
  • Propylene glycol
  • Purified water
  • Sorbitol solution
  • Titanium dioxide

Questions Or Comments?



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


Gentle Reliefstool Softnerdocusate Sodium 100Mggentle And Easy Relief Of Constipation24 Softgelsdistributed By:Healthlife Of Usa Llcrahwaynj 07065Www.Healthlifeofusa.Com



Compare to Dulcolax® Stool Softner active ingredients


* Please review the disclaimer below.