FDA Label for Gentle Laxative

View Indications, Usage & Precautions

Gentle Laxative 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 Laxative 


Purpose



Stimulant Laxative


Active Ingerient (In Each Tablet)



Bisacodyl 5mg


Uses



  • For temporary relief of occasional constipation and irregularity
  • This product generally produces a bowel movement in 6 to 12 hours

Warnings



Do not use

  • If you cannot swallow without chewing

Ask A Doctor Before Use If You Have



  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that last more than 2 weeks

When Using This Product



  • Do not chew or crush tablet(s)
  • Do not use within 1 hour after taking an antacid or milk 
  • It may cause stomach discomfirt, faintness and cramps

Stop Use And Ask A Doctor If



  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition
  • you need to use a laxative for more than 1 week

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. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.


Directions



  • Take with a glass of water 
  • Adults and children 12 years of age and over : Take 1 to 3 tablets in a single daily dose
  • Children 6 to under 12 years of age: Take 1 tablet in a single daily dose
  • Children under 6 years of age: Ask a doctor

Other Information



  • Store at controlled room temperature 20°- 25°C  (68°- 77°F)
  • Read all product information before using 
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING 

Inactive Ingredients



  • Colloidal silicon dioxide
  • Croscarmellose sodium
  • Dicalcium phosphate 
  • FD&C Blue#1
  • FD&C Blue#2
  • Magnesium Stearate
  • Microcrystalline cellulose
  • Polyethylene glycol
  • Polyvinyl alcohol
  • Talc
  • Titanium dioxide

Questions Or Comments?



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