Premier Value 44-676A

Premier Value 44-676A

Drug Labeling and Warnings

Drug Details

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WOMENS GENTLE LAXATIVE- bisacodyl tablet, coated 
Chain Drug Consortium

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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Premier Value 44-676A

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative

Uses

  • for relief of occasional constipation (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

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

When using this product

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

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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 (1-800-222-1222) right away.

Directions

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

Other information

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

Inactive ingredients

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

Questions or comments?

​1-800-426-9391

Principal display panel

*COMPARE TO THE ACTIVE INGREDIENT IN CORRECTOL®

Premier
Value®

Women's
Gentle Laxative
Bisacodyl USP, 5 mg
STIMULANT LAXATIVE

Gentle, dependable
overnight relief

30 Tablets

Enteric coated tablets

INDEPENDENTLY TESTED 
SATISFACTION GUARANTEED

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    ORG041867601

Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087

44-676A

44-676A

WOMENS GENTLE LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68016-197
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
STARCH, CORN (UNII: O8232NY3SJ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID (UNII: 1CS02G8656)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SHELLAC (UNII: 46N107B71O)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize8mm
FlavorImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68016-197-302 in 1 CARTON09/16/2015
115 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 FINALpart33409/16/2015
Labeler - Chain Drug Consortium (101668460)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464PACK(68016-197)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867894MANUFACTURE(68016-197)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.967626305PACK(68016-197)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.832867837PACK(68016-197)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.868734088PACK(68016-197)

Revised: 11/2018
 
Chain Drug Consortium


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