TOPCARE GENTLE LAXATIVE- bisacodyl suppository

TopCare Gentle Laxative by

Drug Labeling and Warnings

TopCare Gentle Laxative by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, Reese Pharmaceutical Co, Biopharm. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Bisacodyl USP, 10 mg

Purpose

Stimulant Laxative

Uses

• For relief of occasional constipation and irregularity
• -This product generally produces bowel movement in 15 minutes to 1 hour

Warnings

For rectal use only.

ASK DOCTOR

• stomach pain, nausea or vomiting
  
• noticed a sudden change in bowel habits that persists over a period of two weeks

When using this product

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

STOP USE

Stop use and ask a doctor if

• if you have rectal bleeding or fail to have bowel movement after using a laxative. This may indicate a serious condition
• you need to use a laxative for more than 1 week

PREGNANCY OR BREAST FEEDING

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

•  do not store above 30°C (86°F)

Inactive Ingredients

hydrogenated vegetable oil

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE GENTLE LAXATIVE 
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-808
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	10 mg  in 2000 mg

Inactive Ingredients
Ingredient Name	Strength
FAT, HARD (UNII: 8334LX7S21)	1990 mg  in 2000 mg

Product Characteristics
Color	white	Score
Shape	BULLET	Size	34mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-808-08	2 in 1 CARTON	11/16/2015
1		40 mg in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/13/2015

Labeler - Topco Associates LLC (006935977)

Registrant - Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Reese Pharmaceutical Co		004172052	relabel(36800-808) , repack(36800-808)

Establishment
Name	Address	ID/FEI	Business Operations
Biopharm		801652546	manufacture(36800-808)