TOPCARE LAXATIVE- bisacodyl tablet 
Topco Associates LLC

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.

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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 over

take 1-3 tablets (usually 2) daily

children 6 to under 12 years

take 1 tablet daily

children under 6 years

ask 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

Laxative Tablets Carton

Laxative Tablets Carton

TOPCARE LAXATIVE 
bisacodyl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-086
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
TALC (UNII: 7SEV7J4R1U)  
Product Characteristics
ColorYELLOW (yellow to orange mix) Scoreno score
ShapeROUNDSize6mm
FlavorImprint Code 086
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-086-631 in 1 CARTON10/06/199705/10/2014
125 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/06/199705/10/2014
Labeler - Topco Associates LLC (006935977)

Revised: 11/2017
 
Topco Associates LLC