LEADER GENTLE LAXATIVE- bisacodyl suppository suppository

United States - English - NLM (National Library of Medicine)

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Active ingredient:
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)
Available from:
Cardinal Health
Administration route:
RECTAL
Prescription type:
OTC DRUG
Therapeutic indications:
Uses - For temporary relief of occasional constipation and irregularity -This product generally produces bowel movement in 15 minutes to 1 hour 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  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 Stimulant Laxative
Authorization status:
OTC monograph not final
Authorization number:
70000-0451-1, 70000-0451-4

LEADER GENTLE LAXATIVE- bisacodyl suppository suppository

Cardinal Health

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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Active Ingredient (in each Suppository)

Purpose

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

Us es

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 30 C (86 F)

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

Inactive ingredient

Inactive ingredient Hydrogenated vegetable oil

Purpos e

Stimulant Laxative

Qutes tions ?

Questions? 1-724-733-7381

Product Label

LEADER GENTLE LAXATIVE

bisacodyl suppository suppository

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 0 0 0 -0 451

Route of Administration

RECTAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

BISACO DYL (UNII: 10 X0 70 9 Y6 I) (DEACETYLBISACODYL - UNII:R0 9 0 78 E41Y)

BISACODYL

10 mg in 20 0 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

PALM KERNEL O IL (UNII: B0 S9 0 M0 233)

19 9 0 mg in 20 0 0 mg

Product Characteristics

Color

white

S core

S hap e

BULLET

S iz e

32mm

Cardinal Health

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:70 0 0 0 -0 451-

1 in 1 CARTON

0 1/24/20 19

1

NDC:70 0 0 0 -0 451-

40 mg in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt334

0 1/24/20 19

Labeler -

Cardinal Health (097537435)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Unipack, Inc.

0 0 9 248 48 0

ma nufa c ture (70 0 0 0 -0 451)

Revised: 1/2019

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