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  5. Label Information: Simpex Bisacodyl Laxative

FDA Label for Simpex Bisacodyl Laxative

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABELING:

Simpex Bisacodyl Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Simpex Pharma Pvt. Ltd. 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





Active Ingredient (In Each Tablet)



Bisacodyl 5 mg


Purpose



Stimulant Laxative


Uses



  • relives occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours

Do Not Use



  • if you can not swallow without chewing. ask a doctor before use if you have
  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than weeks

When Using This Product



  • do not chew or crush tablet (s)
  • do not use within 1 hour after taking an antacid or milk
  • you may have stomach discomfort, faintness or cramps

Stop Use And Ask A Doctor If



  • you have rectal bleeding or fail to have a bowel movement after use a laxative. 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 or overdose, get medical help orcontact a poison control center right away.


Directions



  • take with a glass of water.
    • Adults and children 12 years and overtake 1 to 3 tablets in a single daily dose
    Children 6 to under 12 years of agetake 1 tablet in a single daily dose
    Children under 6 yearsask a doctor


Other Information



  • preserve in well-closed containers at a temperature not exceeding 30°C 
  • avoid excessive humidity

Inactive Ingredients



anhydrous lactose, colloidal anhydrous silica, hypermellose, iron oxide red, iron oxide yellow, macrogol, magnesium stearate, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, povidone, sodium bicarbonate, sodiumlauryl sulfate, sodium starch glycolate type A, talc, titanium dioxide,triethyle citrate


Package Labeling:



Label3 - Label3

Label3 - Label3


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