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NDC 70518-2976-01 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 REMEDYREPACK INC.. 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: 70518-2976-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bisacodyl

Product Information

NDC	70518-2976
Product ID	70518-2976_dd2f68f1-d008-2f60-e053-2995a90a7215
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	REMEDYREPACK INC.
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 70518-2976-01 (70518297601)

Pricing Information	N/A
NDC Package Code	70518-2976-1
Billing NDC	70518297601
Package	100 POUCH in 1 BOX (70518-2976-1) / 1 TABLET in 1 POUCH (70518-2976-2)
Marketing Start Date	2021-08-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8af00ea4-6e50-49a1-96c6-bb47d50caf8e 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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

PRINCIPAL DISPLAY PANEL

DRUG: stimulant laxative enteric coated

GENERIC: Bisacodyl

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-2976-0

NDC: 70518-2976-1

NDC: 70518-2976-2

COLOR: orange

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: 5

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 100 in 1 BOX

PACKAGING: 1 in 1 POUCH

ACTIVE INGREDIENT(S):

BISACODYL 5mg in 1

INACTIVE INGREDIENT(S):

SODIUM ALGINATE
SHELLAC
POVIDONE
PROPYLENE GLYCOL
PROPYLPARABEN
POLYVINYL ACETATE PHTHALATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYDEXTROSE
METHYLPARABEN
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE
FERROSOFERRIC OXIDE
HYPROMELLOSES
FD&C YELLOW NO. 6
SILICON DIOXIDE
STARCH, CORN
CARNAUBA WAX
CALCIUM CARBONATE
AMMONIA
ACACIA
TRIETHYL CITRATE
TRIACETIN
TITANIUM DIOXIDE
TALC
SUCROSE
STEARIC ACID
SODIUM BICARBONATE
SODIUM BENZOATE
DIMETHICONE
D&C YELLOW NO. 10

INGREDIENTS AND APPEARANCE

STIMULANT LAXATIVE ENTERIC COATED

bisacodyl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-2976(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)
HYPROMELLOSES (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 (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:70518-2976-0	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	12/22/2020
2	NDC:70518-2976-1	100 in 1 BOX	08/03/2021
2	NDC:70518-2976-2	1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	12/22/2020

Labeler - REMEDYREPACK INC. (829572556)

Revised: 4/2022

Document Id: dd2f68f1-d008-2f60-e053-2995a90a7215

Set id: 8af00ea4-6e50-49a1-96c6-bb47d50caf8e

Version: 3

Effective Time: 20220421