TOPCARE GENTLE LAXATIVE- bisacodyl  suppository 
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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DRUG FACTS

Active ingredient

Bisacodyl USP, 10 mg


Purpose

Stimulant Laxative

Uses

Warnings

For rectal use only.

When using this product

May cause abdominal discomfort, faintness, rectal burning, and mild cramps

Stop use and ask a doctor if

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

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and older                           Children 6 to under 12 years                     Children under 6

One suppository once daily                                                        1/2 suppository once daily                        Ask doctor.

-Detach one suppository from the strip and remove from foil - Carefully insert one suppositry well into the rectum

-Do not use more than once per day

Other Information

Inactive Ingredients

hydrogenated vegetable oil

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TOPCARE GENTLE LAXATIVE 
bisacodyl suppository
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-808
Route of AdministrationRECTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg  in 2000 mg
Inactive Ingredients
Ingredient NameStrength
FAT, HARD (UNII: 8334LX7S21) 1990 mg  in 2000 mg
Product Characteristics
ColorwhiteScore    
ShapeBULLETSize34mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-808-082 in 1 CARTON11/16/2015
140 mg 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 finalpart33402/13/2015
Labeler - Topco Associates LLC (006935977)
Registrant - Reese Pharmaceutical Co (004172052)
Establishment
NameAddressID/FEIBusiness Operations
Reese Pharmaceutical Co004172052relabel(36800-808) , repack(36800-808)
Establishment
NameAddressID/FEIBusiness Operations
Biopharm801652546manufacture(36800-808)

Revised: 8/2017
Document Id: e64fc896-056a-4ab3-80db-e07559e21301
Set id: 11eeb713-4f7d-4965-b12b-6798b23b96f6
Version: 1
Effective Time: 20170830
 
Topco Associates LLC