WOMENS LAXATIVE ENTERIC COATED- bisacodyl tablet, coated

WOMENS LAXATIVE ENTERIC COATED by

Drug Labeling and Warnings

WOMENS LAXATIVE ENTERIC COATED by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, TIME CAP LABORATORIES, INC., TIME CAP LABORATORIES, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

In each tablet: Bisacodyl 5mg

PURPOSE

Stimulant Laxative

INDICATIONS & USAGE

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

WARNINGS

Warnings

DO NOT USE

Do not useif you cannot swallow without chewing

ASK DOCTOR

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

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 or cramps

STOP USE

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

PREGNANCY OR BREAST FEEDING

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 overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

DOSAGE & ADMINISTRATION

• take with a glass of water

adults and children 12 years and over take 1 to 3 tablets in a single daily dose

children 6 to under 12 years of age take 1 tablet in a single daily dose

children under 6 years of age ask a doctor

Other Information

• each tablet contains:magnesium 5mg
• store at 25°C (77F) excursions permitted between 15° - 30°C (59° - 86°F)
• use by expiration date on package
  • protect from excessive humidity

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WOMENS LAXATIVE ENTERIC COATED 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0570
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)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
RAW SUGAR (UNII: 8M707QY5GH)
ACACIA (UNII: 5C5403N26O)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
STEARIC ACID (UNII: 4ELV7Z65AP)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 (UNII: 2LRS185U6K)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
FERROUS OXIDE (UNII: G7036X8B5H)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SHELLAC (UNII: 46N107B71O)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	TCL
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0570-1	1 in 1 CARTON	07/24/2020
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 Drug	M007	07/24/2020

Labeler - CARDINAL HEALTH (063997360)

Registrant - TIME CAP LABORATORIES, INC. (037005209)

Establishment
Name	Address	ID/FEI	Business Operations
TIME CAP LABORATORIES, INC		037052099	manufacture(70000-0570)