MEIJER GENTLE LAXATIVE- bisacodyl suppository

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)

Available from:

Meijer Distribution Inc.

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

Summary of Product characteristics

MEIJER GENTLE LAXATIVE- BISACODYL SUPPOSITORY
MEIJER DISTRIBUTION INC.
_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._
----------
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
MEIJER GENTLE LAXATIVE
bisacodyl suppository
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:41250 -353
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)
19 9 0 mg in 20 0 0 mg
PRODUCT CHARACTERISTICS
COLOR
white
S CORE
S HAP E
BULLET
S IZ E
3