GOOD NEIGHBOR PHARMACY GENTLE LAXATIVE- bisacodyl suppository

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

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Active ingredient:
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)
Available from:
AmerisourceBergen Drug Corp
Administration route:
RECTAL
Prescription type:
OTC DRUG
Therapeutic indications:
Stimulant Laxative - For relief of occasional constipation and irregularity - -This product generally produces bowel movement in 15 minutes to 1 hour 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
Authorization status:
OTC monograph not final
Authorization number:
46122-608-51

GOOD NEIGHBOR PHARMACY GENTLE LAXATIVE- bisacodyl suppository

AmerisourceBergen Drug Corp

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

Purpos e

Stimulant Laxative

Us es

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

GOOD NEIGHBOR PHARMACY GENTLE LAXATIVE

bisacodyl suppository

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:46 122-6 0 8

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

FAT, HARD (UNII: 8 334LX7S21)

Product Characteristics

Color

white

S core

S hap e

BULLET

S iz e

34mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:46 122-6 0 8 -

2 in 1 CARTON

11/16 /20 15

1

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 2/13/20 15

Labeler -

AmerisourceBergen Drug Corp (007914906)

Registrant -

Reese Pharmaceutical Co (004172052)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Reese Pharmaceutical Co

0 0 41720 52

relabel(46 122-6 0 8 ) , repack(46 122-6 0 8 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

AmerisourceBergen Drug Corp

DSC Labo rato ries, Inc.

0 9 78 0 7374

ma nufa c ture (46 122-6 0 8 )

Revised: 3/2019

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