WOMENS LAXATIVE- bisacodyl tablet, delayed release

Womens Laxative by

Drug Labeling and Warnings

Womens Laxative by is a Otc medication manufactured, distributed, or labeled by Marc Glassman, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Bisacodyl USP 5mg

Purpose

Stimulant Laxative

Uses

• for relief of occasional constipation and irregularity
• this product usually causes bowel movements in 6 to 12 hours

Warnings

Do not use

• if you cannot swallow without chewing
• within 1 hour after taking antacid or milk

Ask a doctor before use if you have

• abdominal pain
• nausea
• vomiting
• notice a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

• do not chew or crush tablets
• abdominal discomfort, faintness, and cramps may occur

Stop use and ask a doctor if

• you need to use more than 1 week
• rectal bleeding or failure to have a bowel movement after use of a laxative.

These may be signs of a serious condition.

Pregnancy/Breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a doctor or Poison Control Center (1-800-222-1222) right away.

Directions

• take with water  

Adults and children 12 years of age and older: take 1 to 3 tablets in a single dose, once daily  

Children 6 to 12 years of age: take 1 tablet once daily  

Children under 6 years of age: consult a doctor

Other information

• store between 68º to 77ºF (20º to 25ºC)
• do not use if blister unit is broken or torn  

Inactive ingredients

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

Principal Display Panel

 

Womens Laxative

INGREDIENTS AND APPEARANCE

WOMENS LAXATIVE 
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68998-398
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
ACACIA (UNII: 5C5403N26O)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)
POLYDEXTROSE (UNII: VH2XOU12IE)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SUCROSE (UNII: C151H8M554)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68998-398-85	1 in 1 CARTON	07/01/2014
1		25 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	07/01/2014

Labeler - Marc Glassman, Inc. (094487477)