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Womens Gentle Laxative by FRED'S, INC.

Medically reviewed on January 29, 2018

Dosage form: tablet, coated
Ingredients: BISACODYL 5mg
Labeler: FRED'S, INC.
NDC Code: 55315-676

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.

Freds 44-676

Active ingredient (in each tablet)

Bisacodyl 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 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 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?

1-800-426-9391 

Principal Display Panel

freds®

Women's
Gentle Laxative

Bisacodyl 5 mg
Stimulant Laxative

Gentle, Dependable Overnight Relief

30 Enteric Coated Tablets

Actual Size

freds
LAB TESTED
Lab Tested for Quality,
Fred Tested for Satisfaction

Compare to the
active ingredient in:

Correctol®

*This product is not manufactured or distributed by Bayer HealthCare LLC, owner of the registered trademark Correctol®.
50844        ORG051567601

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

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
www.fredsinc.com

freds Promise
Not Happy With This Product?
Just Bring It Back For a Refund!

Freds 44-676

WOMENS GENTLE LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-676
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (DEACETYLBISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
SILICON DIOXIDE 
STARCH, CORN 
FD&C RED NO. 40 
HYPROMELLOSES 
MAGNESIUM STEARATE 
METHACRYLIC ACID 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
SHELLAC 
SODIUM BICARBONATE 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize8mm
FlavorImprint CodeB
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-676-012 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 - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(55315-676)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(55315-676)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(55315-676)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(55315-676)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(55315-676)

 
FRED'S, INC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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