ENTERIC COATED STIMULANT LAXATIVE- bisacodyl tablet, delayed release
Bryant Ranch Prepack

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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14R RUGBY -BISACODYL 5 MG TABLETS (ORANGE)0536-3381

ACTIVE INGREDIENT
In each tablet: Bisacodyl 5mg

Acadia, 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 Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide

PURPOSE
Stimulant Laxative

INDICATIONS & USAGE
Uses: relieves occasional constipation and irregularity - this product generally produces a bowel movement in 6 to 12 hours

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

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 ...

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.

HOW SUPPLIED

Product: 63629-3049

NDC: 63629-3049-6 90 TABLET, DELAYED RELEASE in a BOTTLE

NDC: 63629-3049-2 2 TABLET, DELAYED RELEASE in a BOTTLE

NDC: 63629-3049-3 3 TABLET, DELAYED RELEASE in a BOTTLE

NDC: 63629-3049-4 4 TABLET, DELAYED RELEASE in a BOTTLE

NDC: 63629-3049-5 10 TABLET, DELAYED RELEASE in a BOTTLE

NDC: 63629-3049-1 30 TABLET, DELAYED RELEASE in a BOTTLE

NDC: 63629-3049-7 8 TABLET, DELAYED RELEASE in a BOTTLE

NDC: 63629-3049-8 100 TABLET, DELAYED RELEASE in a BOTTLE

NDC: 63629-3049-9 20 TABLET, DELAYED RELEASE in a BOTTLE

Bisacodyl 5mg Tablet

ENTERIC COATED STIMULANT LAXATIVE
bisacodyl tablet, delayed release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63629-3049(NDC:0536-3381)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	5 mg

Ingredient Name	Strength
Inactive Ingredients
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SHELLAC (UNII: 46N107B71O)
ACACIA (UNII: 5C5403N26O)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63629-3049-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2012	11/27/2019
2	NDC:63629-3049-4	4 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2012	11/27/2019
3	NDC:63629-3049-2	2 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2012	11/27/2019
4	NDC:63629-3049-8	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2012	11/27/2019
5	NDC:63629-3049-5	10 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2012	11/27/2019
6	NDC:63629-3049-9	20 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2012	11/27/2019
7	NDC:63629-3049-3	3 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2012	11/27/2019
8	NDC:63629-3049-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2012	11/27/2019
9	NDC:63629-3049-7	8 in 1 BOTTLE; Type 0: Not a Combination Product	09/22/2012	11/27/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	09/22/2012	11/27/2019

Labeler - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(63629-3049) , RELABEL(63629-3049)

Revised: 8/2021

Document Id: 54eff9d1-d63b-48cc-98ea-ea55c1de4975

Set id: 5f03362d-792e-433c-9375-0fde1cbefa67

Version: 1003

Effective Time: 20210817

Bryant Ranch Prepack