Gentle and Effective Laxative description, usages, side effects, indications, overdosage, supplying and lots more!

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Gentle and Effective Laxative

Western Family Foods, Inc.

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each enteric coated tablet)

Drug Facts

Purpose

Stimulant laxative

Use

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces a 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)
  • do not use within 1 hour after taking an antacid or milk
  • it may cause stomach discomfort, faintness and cramps 

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using 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 

Gentle and Effective Laxative Other information

  • store between 20º-25ºC (68º-77ºF)

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, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Questions or comments?

Call: 1-503-639-6300 Monday-Friday 8AM-4PM PST

Principal Display Panel

Overnight Relief for simple Constipation

ENTERIC COATED

Gentle & Effective Laxative

Bisacodyl USP, 5 mg

Enteric Comfort Coated TABLETS

5 mg each

*Compare to the Active Ingredient in Dulcolax®

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of Dulcolax® Laxative.

Proudly Distributed by Western Family Foods, Inc.

P.O. Box 4057, Portland, OR  97208 U.S.A.

www.westernfamily.com

Package Label

Gentle and Effective Laxative
Western Family Laxative Tablet

Gentle and Effective Laxative

Bisacodyl TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55312-190
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
GELATIN
MAGNESIUM STEARATE
cellulose, microcrystalline
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
talc
titanium dioxide
POLYVINYL ACETATE PHTHALATE
POVIDONES
ferric oxide red
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
polyethylene glycol 400
SUCROSE
ALUMINUM OXIDE

Product Characteristics

Color Size Imprint Code Shape
ORANGE 6 mm TCL003 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 25 in 1 BLISTER PACK
2 NDC:55312-190-25 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part334 2013-03-08


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Be sure to consult your doctor before taking any medication!
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