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  5. Label Information: Stimulant Laxative

FDA Label for Stimulant Laxative

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. STOP USE AND ASK A DOCTOR IF
    6. IF PREGNANT OR BREAST-FEEDING,
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DOSAGE & ADMINISTRATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?
    11. DISPLAY PANEL

Stimulant Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Retail Business Services, 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.

Otc - Active Ingredient



Active ingredient                 

(In each tablet)

  Bisacodyl 5mg


Purpose



Stimulant Laxative


Indications & Usage



Uses

  • relieves 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 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


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 1(800) 222-1222.


Dosage & Administration



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

Inactive Ingredients



Acadia, 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 Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide


Questions Or Comments?



1-888-333-9792


Display Panel



GENTLE LAXATIVE

BISACODYL 5 mg

GENTLE YET EFFECTIVE STIMULANT LAXATIVE

25 TABLETS

ENTERIC COATED


* Please review the disclaimer below.