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]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

PURPOSE

Purpose

Stimulant laxative

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

Do not use

• if you cannot swallow without chewing

Ask a doctor before use if you have

• stomach pain, nausea or vomiting
• noticed a sudden change in bowel habits that lasts more than 2 weeks

When using this product

• it may cause stomach discomfort, faintness and cramps
• do not chew or crush tablet(s)
• do not use within 1 hour after taking an antacid or milk

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after using this product. 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 right away (1-800-222-1222).

DOSAGE & ADMINISTRATION

Directions

• take with a glass of water

• adults and children 12 years of age and over:

  1 to 3 tablets in a single daily dose

• children 6 to under 12 years of age:

  1 tablet in a single daily dose

• children under 6 years of age:

  ask a doctor

INACTIVE INGREDIENT

Inactive ingredients acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, 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 phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

QUESTIONS

Questions or comments? Call 1-877-290-4008

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 ALUMINUM LAKE (UNII: 4AQJ3LG584)
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)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE (UNII: FZ989GH94E)
ACACIA (UNII: 5C5403N26O)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
IRON OXIDES (UNII: 1K09F3G675)

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 Drug	M007	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)