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NDC 71335-1750-09 Bisacodyl 5 mg/1 Details

Bisacodyl 5 mg/1

Bisacodyl is a ORAL TABLET, COATED 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: 71335-1750-09
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bisacodyl

Product Information

NDC	71335-1750
Product ID	71335-1750_117d43b1-2a67-4aaa-b33e-614d07144ba1
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	Bisacodyl
Proprietary Name Suffix	n/a
Non-Proprietary Name	Bisacodyl
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, COATED
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 71335-1750-09 (71335175009)

Pricing Information	N/A
NDC Package Code	71335-1750-9
Billing NDC	71335175009
Package	20 TABLET, COATED in 1 BOTTLE (71335-1750-9)
Marketing Start Date	2022-02-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL da925c7f-9642-49ff-8d09-d15b48d50400 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each tablet)

Bisacodyl 5 mg

SPL UNCLASSIFIED SECTION

Purpose

Stimulant Laxative

SPL UNCLASSIFIED SECTION

Uses

for relief of occasional constipation and irregularity

this product generally produces bowel movement in 6 to 12 hours

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Other information

Tamper Evident: Do not use if imprinted seal under cap is missing or broken
store at room temperature15°-30°C (59°-86°F)
avoid excessive humidity
package not child resistant

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Questions or comments? call 516-341-0666, 8:30 am - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

Distributed by: Reliable-1 Laboratories, LLC

Valley Stream, NY 11580

www.reliable1labs.com

*This product is not manufactured or distributed by the owner of the registered trademark Dulcolax®

HOW SUPPLIED

NDC: 71335-1750-0: 25 Tablets in a BOTTLE

NDC: 71335-1750-1: 30 Tablets in a BOTTLE

NDC: 71335-1750-2: 2 Tablets in a BOTTLE

NDC: 71335-1750-3: 3 Tablets in a BOTTLE

NDC: 71335-1750-4: 4 Tablets in a BOTTLE

NDC: 71335-1750-5: 10 Tablets in a BOTTLE

NDC: 71335-1750-6: 90 Tablets in a BOTTLE

NDC: 71335-1750-7: 8 Tablets in a BOTTLE

NDC: 71335-1750-8: 100 Tablets in a BOTTLE

NDC: 71335-1750-9: 20 Tablets in a BOTTLE

PRINCIPAL DISPLAY PANEL

Bisacodyl 5mg Tablet

INGREDIENTS AND APPEARANCE

BISACODYL

bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71335-1750(NDC:69618-058)
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)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
CARNAUBA WAX (UNII: R12CBM0EIZ)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
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:71335-1750-0	25 in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2022
2	NDC:71335-1750-1	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2022
3	NDC:71335-1750-2	2 in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2022
4	NDC:71335-1750-3	3 in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2022
5	NDC:71335-1750-4	4 in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2022
6	NDC:71335-1750-5	10 in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2022
7	NDC:71335-1750-6	90 in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2022
8	NDC:71335-1750-7	8 in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2022
9	NDC:71335-1750-8	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2022
10	NDC:71335-1750-9	20 in 1 BOTTLE; Type 0: Not a Combination Product	02/24/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	01/01/2020

Labeler - Bryant Ranch Prepack (171714327)

Registrant - Bryant Ranch Prepack (171714327)

Name	Address	ID/FEI	Business Operations
Establishment
Bryant Ranch Prepack		171714327	REPACK(71335-1750) , RELABEL(71335-1750)

Revised: 2/2022

Document Id: 117d43b1-2a67-4aaa-b33e-614d07144ba1

Set id: da925c7f-9642-49ff-8d09-d15b48d50400

Version: 100

Effective Time: 20220224

Search by Drug Name or NDC

NDC 71335-1750-09 Bisacodyl 5 mg/1 Details

Bisacodyl 5 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71335-1750-09 (71335175009)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL da925c7f-9642-49ff-8d09-d15b48d50400 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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HOW SUPPLIED

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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