STIMULANT LAXATIVE ENTERIC COATED- bisacodyl tablet

stimulant laxative enteric coated by

Drug Labeling and Warnings

stimulant laxative enteric coated by is a Otc medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant Laxative

Uses

• relieves occasional constipation and irregularity

• generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use

for more than one week unless directed by a doctor

if you cannot swallow without chewing

within 1 hour after taking an antacid or milk

Ask a doctor before use if you have

abdominal pain

nausea

vomiting

a sudden change in bowel habits that lasts longer than 2 weeks

When using this product abdominal discomfort, faintness, or cramps may occur

Stop use and ask a doctor

if you have no bowel movement within 12 hours

if you have rectal bleeding

these could be signs of a serious condition

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.

Directions

do not take more than directed
swallow whole, do not chew or crush
take recommended dose in a single daily dose
take with water
adults and children 12 years and older: take 1-3 (usually 2) tablets daily
children 12 and under: ask a doctor

Other information

store at room temperature
avoid excessive humidity
Tamper Evident: Do not use if imprinted seal under cap is missing or broken
package not child resistant
for institutional use only

Inactive ingredients

Acacia, Ammonium Hydroxide, Calcium Carbonate, Corn Starch, D and C Yellow NO. 10 Lake, FD and C Yellow NO. 6 Lake, Hypromellose, Iron Oxide Black, Lactose, Magnesium Stearate, Methylparaben, PEG, Polydextrose, Polyvinyl Acetate Phthalate, Propylparaben, Propylene Glycol, Povidone, Shellac, Simethicone, Silica, Sodium Alginate, Sodium Benzoate, Sodium Bicarbonate, Stearic Acid, Sucrose, Talc, Titanium Dioxide, Triacetin, Triethyl Citrate, Wax. May also contain: Calcium Sulfate, Gelatin, Sodium Starch Glycolate.

HOW SUPPLIED

Product: 71335-1531

NDC: 71335-1531-1 30 TABLET in a BOTTLE

NDC: 71335-1531-2 2 TABLET in a BOTTLE

NDC: 71335-1531-3 3 TABLET in a BOTTLE

NDC: 71335-1531-4 4 TABLET in a BOTTLE

NDC: 71335-1531-5 10 TABLET in a BOTTLE

NDC: 71335-1531-6 90 TABLET in a BOTTLE

NDC: 71335-1531-7 8 TABLET in a BOTTLE

NDC: 71335-1531-8 100 TABLET in a BOTTLE

NDC: 71335-1531-9 20 TABLET in a BOTTLE

Bisacodyl 5mg Tablet

INGREDIENTS AND APPEARANCE

STIMULANT LAXATIVE ENTERIC COATED 
bisacodyl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71335-1531(NDC:57896-441)
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)
AMMONIA (UNII: 5138Q19F1X)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYDEXTROSE (UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71335-1531-8	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2020
2	NDC: 71335-1531-2	2 in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2020
3	NDC: 71335-1531-5	10 in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2020
4	NDC: 71335-1531-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2020
5	NDC: 71335-1531-3	3 in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2020
6	NDC: 71335-1531-9	20 in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2020
7	NDC: 71335-1531-4	4 in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2020
8	NDC: 71335-1531-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2020
9	NDC: 71335-1531-7	8 in 1 BOTTLE; Type 0: Not a Combination Product	03/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/01/2000

Labeler - Bryant Ranch Prepack (171714327)

Establishment
Name	Address	ID/FEI	Business Operations
Bryant Ranch Prepack		171714327	REPACK(71335-1531) , RELABEL(71335-1531)