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  5. Label Information: Bisacodyl Stimulant Laxative

FDA Label for Bisacodyl Stimulant Laxative

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. OTC - STOP USE
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DOSAGE & ADMINISTRATION
    13. STORAGE AND HANDLING
    14. INACTIVE INGREDIENT
    15. OTC - QUESTIONS
    16. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bisacodyl Stimulant Laxative Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. 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 5 mg

Otc - Purpose



PurposeLaxative

Indications & Usage



Uses
  • relieves occasional constipation
  • generally produces bowel movement in 6-12 hours

Warnings



Warnings

Otc - Do Not Use



Do not use
  • for longer than one week
  • when abdominal pain, nausea or vomiting are present
  • in children under 6 years of age
  • in persons who cannot swallow without chewing

Otc - Ask Doctor



Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks

Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Otc - When Using



When using this product
  • do not take dose within one hour of taking an antacid or milk
  • you may experience abdominal discomfort, faintness and cramps

Otc - Stop Use



Stop use and ask a doctor if
  • you have rectal bleeding
  • you fail to have a bowel movement after use of this product
    • These may indicate a serious condition.

Otc - Pregnancy Or Breast Feeding



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

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration



DirectionsDO NOT CHEW TABLETSadults and children 12 years and over: 1-3 tablets once dailychildren 6 to 11 years: 1 tablet once dailychildren under 6 years: ask a doctor

Storage And Handling



Other informationstore at 20°-25°C (68°-77°F)

Inactive Ingredient



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?call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday

Package Label.Principal Display Panel




BOTTLE LABEL - 2497

BOTTLE LABEL - 2497


Bisacodyl

Delayed-Release Tablets USP, 5 mg

Enteric Coated Stimulate Laxative

NDC 54868-2497-0

100 tablets



Distributed by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146



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