WOMENS GENTLE LAXATIVE- bisacodyl tablet, coated 
FRED'S, 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.

----------

Freds 44-326

Active ingredient (in each enteric coated tablet)

Bisacodyl 5 mg

Purpose

Stimulant laxative

Uses

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

 adults and children over 12 years of age oral 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

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

Fred's 44-326


WOMENS GENTLE LAXATIVE 
bisacodyl tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-326
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL 5 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA (UNII: 5C5403N26O)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
Color PINK Score no score
Shape ROUND Size 11mm
Flavor Imprint Code 44;326
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55315-326-01 1 in 1 CARTON
1 30 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 02/12/2005
Labeler - FRED'S, INC. (005866116)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 PACK(55315-326)
Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 MANUFACTURE(55315-326)

Revised: 3/2013
Document Id: 934276b2-384c-47f3-8f1d-7e5f03708e13
Set id: 87b395cb-fada-4785-92f5-c32a6d6ae674
Version: 2
Effective Time: 20130319
 
FRED'S, INC.