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 CVS HEALTH CORP, TIME CAP LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT
In each tablet: Bisacodyl 5mg

In each tablet: Bisacodyl 5mg

INACTIVE INGREDIENT

Acadia, Anhydrous Calcium Sulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C red #27, FD&C blue#2 FD&C yellow #6 aluminum lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow(Iron Oxide Ochre), Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide

PURPOSE

PURPOSE
Stimulant Laxative

Stimulant Laxative

INDICATIONS & USAGE

Uses:

relieves occasional constipation and irregularity
this product generally produces a bowel movement in 6 to 12 hours

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION
adults and children 12 years 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

KEEP OUT OF REACH OF CHILDREN

Keep out of Reach of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.

WARNINGS

Warning: Do not use if you cannot swallow without chewing.

Ask a doctor before use if you have: stomach pain, nausea or vomiting; A sudden change in bowel habits that lasts more than two weeks.

When using this product: Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomach discomfort, faintness or cramps.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WOMENS GENTLE LAXATIVE 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-089
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
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
STARCH, CORN (UNII: O8232NY3SJ)
GELATIN (UNII: 2G86QN327L)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
SHELLAC (UNII: 46N107B71O)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE (UNII: FZ989GH94E)
ACACIA (UNII: 5C5403N26O)
CALCIUM SULFATE (UNII: WAT0DDB505)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-089-52	25 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/24/2020

Labeler - CVS HEALTH CORP (062312574)

Registrant - TIME CAP LABORATORIES, INC. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC.		037052099	manufacture(69842-089)