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Womens Gentle Laxative by Chain Drug Consortium

Dosage form: tablet, coated
Ingredients: BISACODYL 5mg
Labeler: Chain Drug Consortium
NDC Code: 68016-197

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.

Premier Value 44-676

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant laxative

Uses
  • for the relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 6 to 12 hours

Warnings


Do not use

if you are unable to swallow without chewing.

Ask a doctor before use if you have
  • abdominal pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product
  • abdominal discomfort, faintness, and cramps may occur
  • do not use for a period longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

rectal bleeding or failure to have a bowel movement occurs after use of a laxative.
These may be signs of a serious condition.

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 (1-800-222-1222) right away.

Directions
  • do not chew or crush tablets
  • do not take within 1 hour after taking an antacid or milk
  • take with water
  • adults and children 12 years and over: take 1 to 3 tablets in a single dose, once daily
  • children under 12 years: ask a doctor

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER UNIT IS TORN OR BROKEN
  • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
  • see end flap for expiration date and lot number

Inactive ingredients

anhydrous lactose, carmine, colloidal silicon dioxide, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, methacrylic acid, polydextrose, polyethylene glycol, shellac wax, simethicone, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

‚Äč1-800-426-9391

Principal display panel

NDC 68016-197-30

*COMPARE TO THE ACTIVE INGREDIENT IN CORRECTOL®

Premier
Value®

Women's
Gentle Laxative
Bisacodyl 5 mg
STIMULANT LAXATIVE

Gentle, dependable
overnight relief

30 Tablets

Enteric coated tablets

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

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Correctol®.

50844 ORG051567601

DISTRIBUTED BY
CHAIN DRUG CONSORTIUM, LLC
UPARC, BLDG. A3, SUITE 338, 1020 WILLIAM PITT WAY
PITTSBURGH, PA 15238
www.chaindrugconsortium.com

Premier Value 44-676

WOMENS GENTLE LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-197
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (DEACETYLBISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
STARCH, CORN 
FD&C RED NO. 40 
HYPROMELLOSES 
MAGNESIUM STEARATE 
METHACRYLIC ACID 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
SODIUM BICARBONATE 
SODIUM LAURYL SULFATE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-197-302 BLISTER PACK in 1 CARTON
115 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33409/16/2015
Labeler - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(68016-197)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(68016-197)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(68016-197)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(68016-197)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(68016-197)

Revised: 10/2016
 
Chain Drug Consortium

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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