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Laxative

Freds Inc
P and L Development of New York Corporation

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each enteric coated tablet)

Bisacodyl, USP 5 mg

Purpose

Stimulant laxative

Use

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

if you cannot swallow without chewing

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

When using this product

  • do not chew or crush tablet(s)
  • it may cause stomach discomfort, faintness and cramps
  • do not use within 1 hour after taking an antacid or milk

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of 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

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take with a glass of water

 adults and children 12 years of age and over  take 1 to 3 tablets in a single daily dose
 children 6 to under 12 years of age  take 1 tablet in a single daily dose
 children under 6 years of age  ask a doctor

Laxative Other information

  • store at controlled room temperature 15o- 30o C (59o- 86o F)

Inactive ingredients

acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, gelatin, iron oxide, iron oxide Black, iron oxide Yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, and titanium dioxide

Questions or Comments?

Call toll free: 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

*Compare to the active ingredient in DULCOLAX®

*This product is not manufactured or distributed by Boehringer Ingelheim Consumer Healthcare Products, owner of the registered trademark Dulcolax®

LAXATIVE TABLETS

Bisacodyl, USP 5 mg

Gentle, Predictable Overnight relief from constipation

EACH TABLET IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER FOIL IS BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Laxative
Bisacodyl 5 mg tablets

Laxative

Bisacodyl TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55315-190
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Bisacodyl Bisacodyl 5 mg

Inactive Ingredients

Ingredient Name Strength
ACACIA
CALCIUM SULFATE ANHYDROUS
ANHYDROUS LACTOSE
carnauba wax
SILICON DIOXIDE
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
ALUMINUM OXIDE
GELATIN
ferric oxide red
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol 400
POLYVINYL ACETATE PHTHALATE
POVIDONES
SHELLAC
sodium starch glycolate type a corn
STEARIC ACID
talc
titanium dioxide
SUCROSE

Product Characteristics

Color Size Imprint Code Shape
YELLOW 6 mm TCL003 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 25 in 1 BLISTER PACK
2 NDC:55315-190-03 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-07-08


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Be sure to consult your doctor before taking any medication!
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