WOMENS GENTLE LAXATIVE- bisacodyl tablet, coated

Womens Gentle Laxative by

Drug Labeling and Warnings

Womens Gentle Laxative by is a Otc medication manufactured, distributed, or labeled by FRED'S, INC., LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 12years 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 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

freds®
Pharmacy

NDC: 55315-676-01

Women's
Gentle Laxative

Bisacodyl USP, 5 mg / Stimulant Laxative

Gentle, Predictable Overnight Relief

Actual Size

30 COMFORT COATED
TABLETS

50844        ORG041867601

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

100%
Satisfaction
guaranteed
Questions or comments:
1-855-331-FRED (3733)

Freds 44-676A

INGREDIENTS AND APPEARANCE

WOMENS GENTLE LAXATIVE 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-676
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	5 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID (UNII: 1CS02G8656)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SHELLAC (UNII: 46N107B71O)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
DIMETHICONE (UNII: 92RU3N3Y1O)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	B
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-676-01	2 in 1 CARTON	09/16/2015
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	09/16/2015

Labeler - FRED'S, INC. (005866116)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(55315-676)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(55315-676)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(55315-676)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(55315-676)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	PACK(55315-676)