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  5. Label Information: Bisacodyl

FDA Label for Bisacodyl

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DOSAGE & ADMINISTRATION
    11. OTHER SAFETY INFORMATION
    12. INACTIVE INGREDIENTS
    13. OTC - QUESTIONS
    14. PRINCIPAL DISPLAY PANEL

Bisacodyl Product Label

The following document was submitted to the FDA by the labeler of this product Spirit Pharmaceuticals Llc. 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 Tablet)



Bisacodyl (USP) 5 mg


Purpose



Stimulant laxative


Uses



  • for temporary relief of occasional constipation and irregularity
  • this product generally produces 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 lasts more than 2
weeks


When Using This Product



■ do not chew or crush tablet(s)
■ it may cause stomach discomfort, faintness and cramps
■ do not use within 1 hour after taking an antacid or milk


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


Otc - Pregnancy Or Breast Feeding



Ifpregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Dosage & Administration



Directions

  • take with a glass of water
    •  adults and children 12 years and over 1 to 3 tablets in a single daily dose
     children 6 to under 12 years of age 1 tablet in a single daily dose
     children under 6 years of age ask a doctor


Other Safety Information



Other information
■ each tablet contains: magnesium 5 mg
■ store at 20-25°C (68-77°F)
■ protect from excessive humidity


Inactive Ingredients



Acacia, anhydrous calcium sulfate, anhydrous lactose,
carnauba wax, colloidal silicon dioxide, corn starch, D&C
Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum
Lake, gelatin, iron oxide, iron oxide black, iron oxide yellow
(iron oxide ochre), magnesium stearate, microcrystalline
cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate
phthalate, povidone, shellac, sodium starch glycolate, stearic
acid, sugar, talc, titanium dioxide


Otc - Questions



Questions or comments? 1-888-333-9792


Principal Display Panel



CABINET

Bisacodyl Tablets,
USP 5 mg


* Please review the disclaimer below.