WOMENS LAXATIVE description, usages, side effects, indications, overdosage, supplying and lots more!

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WOMENS LAXATIVE

Western Family Foods, 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 relief of occasional constipation and irregularity. This product generally produces a bowel movement within 8 to 12 hours if taken at bedtime or within 6 hours if taken before breakfast.

Warnings

Do not use

  • if you are currently taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea, or vomiting are present
  • for longer than 1 week, unless directed by a doctor. Prolonged or continued use of this product can lead to laxative dependency and loss of normal bowel function. Serious side effects from prolonged use or overdose can occur.

Caution

  • do not chew or crush
  • do not give to children under 6 years of age or to persons who cannot swallow without chewing
  • do not take this product within 1 hour after taking an antacid and/or milk
  • this product may cause abdominal discomfort, faintness, rectal burning, and mild cramps

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use

If pregnant or breast-feeding,

ask a health care 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

  • do not take more than 3 tablets daily
 adults and children 12 years of age and older  take 1-3 tablets in a single dose once daily
 children 6 to under 12 years of age  take 1 tablet daily
 children under 6 years of age  consult a doctor

WOMENS LAXATIVE Other information

  • each tablet contains: calcium 15 mg
  • store at 15º-30ºC (59º-86ºF)
  • keep in a dry place

Inactive ingredients

acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, D&C red #7 Calcium Lake, hypromellose phthalate, iron oxide, iron oxide Black, iron oxide Yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, triacetin

Questions or comments?

Call toll free 1-877-753-3935

Principal Display Panel

Overnight Relief

Dependable, Gentle & Effective

Women's Laxative

BISACODYL USP 5 mg Stimulant Laxative

Comfort Coated TABLETS

*Compare to the Active Ingredient in Correctol®

ENTERIC COATED

*This product is not manufactured or distributed by Schering-Plough, owner of the registered trademark Correctol®.

TAMPER EVIDENT - USE ONLY IF BLISTERS ARE INTACT.

Proudly Distributed by:

Western Family Foods, Inc.

P.O. Box 4057

Portland, OR 97208

Product Label

WOMENS LAXATIVE

Western Family Women's Laxative Tablet
 

WOMENS LAXATIVE

Bisacodyl TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55312-120
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
carnauba wax
SILICON DIOXIDE
STARCH, CORN
D&C RED NO. 7
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)
ferric oxide red
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
KAOLIN
MAGNESIUM STEARATE
cellulose, microcrystalline
POLYETHYLENE GLYCOLS
POVIDONES
SHELLAC
sodium starch glycolate type a corn
STEARIC ACID
SUCROSE
talc
titanium dioxide
triacetin

Product Characteristics

Color Size Imprint Code Shape
PINK (polished) 10 mm TCL057 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BLISTER PACK
2 NDC:55312-120-30 2 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2010-07-05


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Be sure to consult your doctor before taking any medication!
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