DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

HEALTHMART GENTLE LAXATIVE- bisacodyl  suppository 
Strategic Sourcing Services 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

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

Warnings

For rectal use only.

• 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 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

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

HEALTHMART GENTLE LAXATIVE 
bisacodyl suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62011-0327
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)

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: 62011-0327-1	2 in 1 CARTON	11/16/2015	08/29/2019
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	08/29/2019

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - Reese Pharmaceutical Co (004172052)

Establishment
Name	Address	ID/FEI	Business Operations
Reese Pharmaceutical Co		004172052	relabel(62011-0327) , repack(62011-0327)

Establishment
Name	Address	ID/FEI	Business Operations
Torrent		116943196	manufacture(62011-0327)

Revised: 8/2019

Document Id: eaff81c4-03fa-454d-8fc6-a61c8b61bf2f

34390-5

Set id: a69bec6e-d49b-450e-b068-61c00ba15152

Version: 2

Effective Time: 20190829

 

Strategic Sourcing Services LLC