TopCare Laxative

Dosage form: tablet
Ingredients: BISACODYL 5mg
Labeler: Topco Associates LLC
NDC Code: 36800-086

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Topco Laxative Tablets Drug Facts

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant laxative

Uses
  • relieves occasional constipation and irregularity
  • this product usually causes 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
  • noticed a sudden change in bowel habits that lasts more than 2 weeks

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.

When using this product
  • do not chew or crush tablets
  • do not give to children under 6 years of age or to persons who cannot swallow without chewing, unless directed by a doctor
  • do not use within 1 hour after taking an antacid or milk
  • abdominal discomfort, faintness, and cramps may occur

Stop use and ask a doctor if
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative because this may indicate a serious condition
  • you need to use a laxative for more than one 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.

Directions
  • take in a single daily dose
adults and children 12 years and overtake 1-3 tablets (usually 2) daily
children 6 to under 12 years take 1 tablet daily
children under 6 yearsask a doctor

Inactive ingredients

acacia, anhydrous lactose, calcium sulfate, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow no. 10, edible ink, FD&C yellow no. 6, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinyl acetate phthalate, povidone, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

Gentle Overnight Relief

Laxative Tablets

(bisacodyl 5 mg)

Stimulant Laxative

Gentle yet effective

Actual Size

Compare to Dulcolax® active ingredient

Laxative Tablets Carton

TOPCARE LAXATIVE 
bisacodyl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-086
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Product Characteristics
ColorYELLOW (yellow to orange mix) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code086
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-086-631 BLISTER PACK (BLISTER PACK) in 1 CARTON
125 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/06/1997
Labeler - Topco Associates LLC (006935977)

Revised: 07/2009
 
Topco Associates LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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