FDA.reportPublic FDA data

Laxative

Manufacturer
Rite Aid Corporation | LNK International, Inc.
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:25:30

Label at a glance#

ProductLaxative
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

do not take more than directed take with a glass of water adults and children 12 years and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years take 1 tablet in a single daily dose children under 6 years ask a doctor

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN avoid excessive humidity see end flap for expiration date and lot number store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP, 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

OTC - DO NOT USE SECTION

if you cannot swallow without chewing.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

When using this product

OTC - WHEN USING SECTION

  • do not use within 1 hour after taking an antacid or milk
  • do not chew or crush tablet(s)
  • it may cause stomach discomfort, faintness, and cramps

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • take with a glass of water
adults and children 12 years and overtake 1 to 3 tablets in a single daily dose
children 6 to under 12 yearstake 1 tablet in a single daily dose
children under 6 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • avoid excessive humidity
  • see end flap for expiration date and lot number
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, ammonium hydroxide, black iron oxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, lactose anhydrous, magnesium stearate, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, pregelatinized starch, propylene glycol, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, sodium citrate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 11822-0790-5

Compare to the active ingredient in
Dulcolax® Laxative Tablets*

FREE
FROM
PARABEN
FREE

LAXATIVE
BISACODYL USP, 5 mg
STIMULANT LAXATIVE
Gentle, dependable constipation relief
Comfort Coated Tablets

ACTUAL SIZE

25
TABLETS

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by A. Nattermann & Cie. GmbH, owner of the registered trademark
Dulcolax® Laxative Tablets.
50844 REV0923B79056

DISTRIBUTED BY: RITE AID,
200 NEWBERRY COMMONS
ETTERS, PA 17319 www.riteaid.com

SATISFACTION
GUARANTEE
If you're not satisfied,
we'll happily refund your money

Rite Aid 44-790
Rite Aid 44-790

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN8
308753bisacodyl 5 MG Delayed Release Oral TabletSCD8
308753bisacodyl 5 MG Enteric Coated Oral TabletSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEACETYLBISACODYL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130011822192330GTIN-13: 0011822192330
EAN-13: 0011822192330
GTIN-12: 011822192330
UPC-A: 011822192330
GTIN storage (14 digits): 00011822192330		rite-aid-44-790-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0790-1Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE258
11822-0790-1Laxative2 in 1 CARTONTABLET, DELAYED RELEASE28
11822-0790-5Laxative1 in 1 CARTONTABLET, DELAYED RELEASE18
11822-0790-5Laxative25 in 1 BLISTER PACKTABLET, DELAYED RELEASE258
11822-0790-6Laxative1 in 1 CARTONTABLET, DELAYED RELEASE18
11822-0790-6Laxative200 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE2008

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
11822-079011822-0790-5, 11822-0790-1, 11822-0790-6

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
BISACODYL10X0709Y6IACTIB
ACACIA5C5403N26OIACT
AMMONIA5138Q19F1XIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
CALCIUM CARBONATEH0G9379FGKIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
Polyvinyl Acetate Phthalate58QVG85GW3IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
SODIUM ALGINATEC269C4G2ZQIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM CITRATE1Q73Q2JULRIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
TRIETHYL CITRATE8Z96QXD6UMIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LaxativeBISACODYLRite Aid Corporationedc31d33-0b6e-458c-9d69-859bbb58b0df2025-12-15WarningsExact identifier
ndc (package): 11822-0790-6
ndc (package): 11822-0790-5
ndc (package): 11822-0790-1
ndc (product): 11822-0790
ndc11 (package): 11822079006
ndc11 (package): 11822079005
ndc11 (package): 11822079001
spl id: ad1b57ad-7111-4dfe-a037-934af4500b1c
spl set id: edc31d33-0b6e-458c-9d69-859bbb58b0df

Reported adverse events (FAERS/openFDA)#

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