Gentle and Effective Laxative by Western Family Foods, Inc. DRUG FACTS

Gentle and Effective Laxative by

Drug Labeling and Warnings

Gentle and Effective Laxative by is a Otc medication manufactured, distributed, or labeled by Western Family Foods, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GENTLE AND EFFECTIVE LAXATIVE ENTERIC COATED- bisacodyl tablet, coated 
Western Family Foods, 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.

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DRUG FACTS

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 

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

Bisacodyl USP 5 mg

Western Family Laxative Tablet

GENTLE AND EFFECTIVE LAXATIVE  ENTERIC COATED
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55312-190
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SHELLAC (UNII: 46N107B71O)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
POVIDONE (UNII: FZ989GH94E)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
SUCROSE (UNII: C151H8M554)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code TCL003
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55312-190-251 in 1 CARTON03/08/201312/31/2019
125 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/08/201312/31/2019
Labeler - Western Family Foods, Inc. (192166072)

Revised: 12/2018
 
Western Family Foods, Inc.