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Womens Gentle Laxative by FRED'S, INC.

Medically reviewed on January 18, 2018

Dosage form: tablet, coated
Ingredients: BISACODYL 5mg
Labeler: FRED'S, INC.
NDC Code: 55315-326

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 44-326-Delisted

Active ingredient (in each enteric coated tablet)

Bisacodyl 5 mg

Purpose

Stimulant laxative

Uses
  • for gentle, overnight relief of occasional constipation (irregularity)

  • this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use
  • in children under 6 years of age

  • in persons who cannot swallow without chewing

Ask a doctor before use if you have
  • abdominal pain

  • nausea

  • vomiting

  • sudden change in bowel movements that persist over a period of 2 weeks

When using this product
  • do not use for a period longer than 1 week unless directed by a doctor

  • you may experience abdominal discomfort, faintness and cramps

Stop use and ask a doctor if
  • rectal bleeding occurs

  • you fail to have a bowel movement

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
  • do not chew or crush tablets

  • do not take within 1 hour after taking an antacid or milk

 adults and children over 12 years of ageoral dosage is 1 to 3 tablets in a single or divided daily dose 
 children 6 to under 12 years of age oral dosage is 1 tablet in a single daily dose
 children under 6 years of age ask a doctor

Other information
  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)

  • protect from moisture

  • see end flap for expiration date and lot number

Inactive ingredients

acacia, black iron oxide, calcium carbonate, carnauba wax, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose,  lactose, magnesium stearate, methylparahydroxy benzoate, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparahydroxy benzoate, shellac glaze, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Principal Display Panel

FRED'S®

Stimulant Laxative

Women's
Gentle Laxative
Bisacodyl 5 mg
Gentle, Dependable Overnight Relief

30 Enteric Coated Tablets

Tested Against The Active Ingredient In: CORRECTOL®*

*This product is not manufactured or distributed Schering-Plough Healthcare Products, owner of the registered trademark Correctol®.
50844        REV0410E32601

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

Fred's 44-326


WOMENS GENTLE LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-326
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
FERROSOFERRIC OXIDE 
CALCIUM CARBONATE 
CARNAUBA WAX 
D&C RED NO. 27 
FD&C BLUE NO. 2 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
MAGNESIUM STEARATE 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
Polyvinyl Acetate Phthalate 
POVIDONES 
PROPYLENE GLYCOL 
SODIUM ALGINATE 
SODIUM BENZOATE 
SODIUM BICARBONATE 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize11mm
FlavorImprint Code44;326
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-326-011 BLISTER PACK in 1 CARTON
130 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33402/12/200512/14/2018
Labeler - FRED'S, INC. (005866116)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(55315-326)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(55315-326)

 
FRED'S, INC.

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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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