ENTERIC COATED STIMULANT LAXATIVE by RUGBY LABORATORIES INC / TIME CAP LABS, INC / TIME CAP LABORATORIES, INC. RUGBY 14R

ENTERIC COATED STIMULANT LAXATIVE by

Drug Labeling and Warnings

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

Drug Details [pdf]

ENTERIC COATED STIMULANT LAXATIVE- bisacodyl tablet, delayed release 
Rugby Laboratories, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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RUGBY 14R

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Laxative

Uses

• relieves occasional constipation
• generally produces bowel movement in 6-12 hours

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

Keep out of reach of children.

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

Directions

DO NOT CHEW TABLETS

adults and children 12 years and over: 1-3 tablets once daily

children 6 to 11 years: 1 tablet once daily

children under 6 years: ask a doctor

Inactive ingredients

acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D-C yellow #10 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

ENTERIC COATED STIMULANT LAXATIVE 
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-3381
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)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
POVIDONE (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	TCL;003
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-3381-01	100 in 1 BOX; Type 0: Not a Combination Product	09/22/2011	01/01/2018
2	NDC: 0536-3381-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2011	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	09/22/2011	01/01/2018

Labeler - Rugby Laboratories, Inc (079246066)

Registrant - Time Cap Labs, Inc (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Labs, Inc		037052099	manufacture(0536-3381)

Revised: 11/2019

Document Id: 98561285-fe3e-8075-e053-2995a90a10c7

34390-5

Set id: c53bda6e-07f6-4871-b9af-5629d8844823

Version: 2

Effective Time: 20191127

 

Rugby Laboratories, Inc