LEADER GENTLE LAXATIVE- bisacodyl suppository suppository

Leader Gentle Laxative by

Drug Labeling and Warnings

Leader Gentle Laxative by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Unipack, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each Suppository)

                                                                   Purpose

Bisacodyl USP, 10 mg.................................Stimulant Laxative

Uses

Uses - For temporary relief of occasional constipation and irregularity

-This product generally produces bowel movement in 15 minutes to 1 hour

Warnings

For rectal use only.

Do not use

Do not use - more than once per day - laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor- for a period of longer than one week unless directed by a doctor 

Ask a doctor

Ask a doctor before use if you have - noticed a sudden change in bowel habits that persists over a period of two weeks

When using this product

When using this product - May cause abdominal discomfort, faintness, rectal burning, and mild cramps

Stop use and ask a doctor

Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after using a laxative.  This may indicate a serious condition

If pregnant or breast-feeding

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

Keep out of reach of children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222) 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, pointed end first

- Retain about 15 to 20 minutes

Other information

Other information - Storage temperature: not to exceed 30oC (86oF)

- Lot No. & Exp. Date: see wrapper or box

Inactive ingredient

Inactive ingredient  Hydrogenated vegetable oil

Purpose

Stimulant Laxative

Qutestions?

Questions? 1-724-733-7381

Product Label

INGREDIENTS AND APPEARANCE

LEADER GENTLE LAXATIVE 
bisacodyl suppository suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-6981
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
PALM KERNEL OIL (UNII: B0S90M0233)	1990 mg  in 2000 mg

Product Characteristics
Color	white	Score
Shape	BULLET	Size	32mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-6981-12	1 in 1 CARTON	10/01/2019
1	NDC: 0904-6981-13	120 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	10/01/2019

Labeler - Major Pharmaceuticals (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
Unipack, Inc.		009248480	manufacture(0904-6981)