FDA.reportPublic FDA data

stimulant laxative enteric coated

Manufacturer
REMEDYREPACK INC.
Effective date
2022-04-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:02:45

Label at a glance#

Productstimulant laxative enteric coated
Active ingredientBISACODYL
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

• 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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl 5 mg

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

• 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-540-3765

Repackaged and Distributed By:

Remedy Repack, Inc.

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

PACKAGE LABEL.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

Remedy_LabelRemedy_Label

MM2MM2

MM3MM3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-441-01EA - Each57896-441e7ebc5d2-1ce7-40e7-bf38-32cc9686493512014-07-02
57896-441-10EA - Each57896-441cda9764f-626f-4803-b355-616daef112c912018-01-12
57896-441-20EA - Each57896-441eb20457a-3154-4cfd-93c7-c4b3f8ff684e12022-03-09
57896-441-25EA - Each57896-44103c2adbe-8c24-470a-b5d5-c3ac0904395212018-01-12
57896-441-26EA - Each57896-44132af55fc-6077-46f2-853e-fbf166be9eb712018-11-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70518-297670518-2976-0, 70518-2976-2, 70518-2976-1
57896-441

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM ALGINATEC269C4G2ZQIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM BICARBONATE8MDF5V39QOIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
ACACIA5C5403N26OIACT
AMMONIA5138Q19F1XIACT
CALCIUM CARBONATEH0G9379FGKIACT
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ACETATE PHTHALATE58QVG85GW3IACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONEFZ989GH94EIACT
SHELLAC46N107B71OIACT
DIMETHICONE92RU3N3Y1OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
BISACODYL10X0709Y6IACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
stimulant laxative enteric coatedBISACODYLGeri-Care Pharmaceutical Corpc3fa1050-bb8b-449c-89e6-f5fd508278d22024-11-28WarningsExact identifier
ndc (product): 57896-441
079ab781-bf11-c728-e063-6394a90ad4998af00ea4-6e50-49a1-96c6-bb47d50caf8e2023-10-13WarningsExact identifier
spl set id: 8af00ea4-6e50-49a1-96c6-bb47d50caf8e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.