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NDC 71335-1531-09 stimulant laxative enteric coated 5 mg/1 Details

stimulant laxative enteric coated 5 mg/1

stimulant laxative enteric coated is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is BISACODYL.

MedlinePlus Drug Summary

Bisacodyl is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Bisacodyl is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.

Related Packages: 71335-1531-09
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bisacodyl

Product Information

NDC	71335-1531
Product ID	71335-1531_06940a9d-02bb-4b8e-b1cf-d69d94a30b67
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	stimulant laxative enteric coated
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bisacodyl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/1
Substance Name	BISACODYL
Labeler Name	Bryant Ranch Prepack
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part334
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71335-1531-09 (71335153109)

Pricing Information	N/A
NDC Package Code	71335-1531-9
Billing NDC	71335153109
Package	20 TABLET in 1 BOTTLE (71335-1531-9)
Marketing Start Date	2022-03-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 06940a9d-02bb-4b8e-b1cf-d69d94a30b67 Details

Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant Laxative

Uses

for relief of occasional constipation and irregularity
this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use if you cannot swallow without chewing

Ask a doctor before use if you have

• stomach pain, nausea, vomiting

• noticed a sudden change in bowel habits that lasts more than 2 weeks

When using this product • do not chew or crush tablet(s)

• do not use within 1 hour after taking an antacid or milk

• it may cause stomach discomfort, faintness and cramps

Stop use and ask a doctor if • you have rectal bleeding or no

bowel movement after using this product.

These could be signs of a serious condition.

• you need to use a laxative for more than 1 week

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

take with a glass of water
adults and children 12 years and older: take 1 to 3 tablets in a single daily dose
children 12 and under: ask a doctor

Other information

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken

• store at room temperature 15°-30°C (59°-86°F)

• avoid excessive humidity • package not child resistant

Inactive ingredients

acacia, ammonium hydroxide,

calcium carbonate, corn starch, D&C yellow #10 lake,

FD&C yellow #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.

Questions or comments?

1-800-540-3765

HOW SUPPLIED

NDC: 71335-1531-0: 25 Tablets in a BOTTLE

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

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

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

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

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

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

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

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

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

PRINCIPAL DISPLAY PANEL

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

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

Ingredient Name	Strength
Inactive Ingredients
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)
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)

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71335-1531-0	25 in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2022
2	NDC:71335-1531-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	05/14/2020
3	NDC:71335-1531-2	2 in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2022
4	NDC:71335-1531-3	3 in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2022
5	NDC:71335-1531-4	4 in 1 BOTTLE; Type 0: Not a Combination Product	03/09/2020
6	NDC:71335-1531-5	10 in 1 BOTTLE; Type 0: Not a Combination Product	06/16/2020
7	NDC:71335-1531-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2022
8	NDC:71335-1531-7	8 in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2022
9	NDC:71335-1531-8	100 in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2022
10	NDC:71335-1531-9	20 in 1 BOTTLE; Type 0: Not a Combination Product	03/10/2022

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

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

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

Revised: 3/2022

Document Id: 06940a9d-02bb-4b8e-b1cf-d69d94a30b67

Set id: 06940a9d-02bb-4b8e-b1cf-d69d94a30b67

Version: 2

Effective Time: 20220310