ENTERIC COATED STIMULANT LAXATIVE- bisacodyl tablet, delayed release

Enteric Coated Stimulant Laxative by

Drug Labeling and Warnings

Enteric Coated Stimulant Laxative by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Bisacodyl 5 mg

PURPOSE

Purpose

Laxative

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

DO NOT USE

Do not use

• for longer than one week
• when abdominal pain, nausea or vomiting are present
• in children under 6 years of age
• in persons who cannot swallow without chewing
  

ASK DOCTOR

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

WHEN USING

When using this product

• do not take dose within one hour of taking an antacid or milk
• you may experience abdominal discomfort, faintness and cramps
  

STOP USE

Stop use and ask a doctor if

• you have rectal bleeding
• you fail to have a bowel movement after use of this product

These may indicate a serious condition.

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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

store at 20°-25°C (68°-77°F)

INACTIVE INGREDIENT

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

QUESTIONS

Questions or comments?

call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday

PRINCIPAL DISPLAY PANEL

Bisacodyl 5mg Tablet

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I)	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)
POVIDONES (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: 63629-3049-1	30 in 1 BOTTLE
2	NDC: 63629-3049-2	2 in 1 BOTTLE
3	NDC: 63629-3049-3	3 in 1 BOTTLE
4	NDC: 63629-3049-4	4 in 1 BOTTLE
5	NDC: 63629-3049-5	10 in 1 BOTTLE
6	NDC: 63629-3049-6	90 in 1 BOTTLE
7	NDC: 63629-3049-7	8 in 1 BOTTLE
8	NDC: 63629-3049-8	100 in 1 BOTTLE

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

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

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