Indications and uses
for temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours
BISACODYL
- Manufacturer
- SPIRIT PHARMACEUTICALS LLC | TIME-CAP LABS, INC.
- Effective date
- 2019-12-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:02:22
Label at a glance#
ProductBISACODYL
Active ingredientBISACODYL
Label structure16 sections
Dosage and administration
take with a glass of water adults and children 12 years and over 1 to 3 tablets in a single daily dose children 6 to under 12 years of age 1 tablet in a single daily dose children under 6 years of age ask a doctor
Storage and handling
each tablet contains: magnesium 5 mg store at 20-25°C (68-77°F) protect from excessive humidity
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each tablet)
Bisacodyl (USP) 5 mg
Purpose
Stimulant laxative
Uses
- for temporary 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 or vomiting
- a sudden change in bowel habits that lasts more than 2 weeks
When using this product
- do not chew or crush tablet(s)
- it may cause stomach discomfort, faintness and cramps
- do not use within 1 hour after taking an antacid or milk
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
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 1(800)222-1222
Directions
take with a glass of water
| adults and children 12 years and over | 1 to 3 tablets in a single daily dose |
| children 6 to under 12 years of age | 1 tablet in a single daily dose |
| children under 6 years of age | ask a doctor |
Other information
- each tablet contains: magnesium 5 mg
- store at 20-25°C (68-77°F)
- protect from excessive humidity
Inactive ingredients
Acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C Yellow#10 Aluminum Lake, FD&C Yellow#6 Aluminum Lake, gelatin, iron oxide, iron oxide black, iron oxide yellow (iron oxide ochre), magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide
Questions or comments?
1-888-333-9792
SPL UNCLASSIFIED SECTION
Distributed By
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779
PRINCIPAL DISPLAY PANEL - 5 mg tablets bottle
VALUMEDS
Compare to the
active ingredient
in DULCOLAX®*
Laxative
BISACODYL USP 5 mg
Gentle
Overnight Relief
100 TABLETS
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEACETYLBISACODYL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20181113 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68210-0312-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-c2e4-0266-e053-dadaa90a7c1a | VALUMEDS LAXATIVE |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-0312-1 | BISACODYL | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68210-0312 | BISACODYL TABLET, DELAYED RELEASE [SPIRIT PHARMACEUTICALS LLC] | 2 | Legacy NDC, 1 package rows | 20191227_6290de48-f30b-4e8d-a974-eb2cfed1d09a.zip |
Products#
Every source-derived product name is available through these pages.
- BISACODYL
- ACACIA
- CALCIUM SULFATE ANHYDROUS
- ANHYDROUS LACTOSE
- CARNAUBA WAX
- SILICON DIOXIDE
- STARCH, CORN
- D&C YELLOW NO. 10
- FD&C YELLOW NO. 6
- GELATIN
- FERROSOFERRIC OXIDE
- FERRIC OXIDE YELLOW
- MAGNESIUM STEARATE
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL 400
- POLYVINYL ACETATE PHTHALATE
- POVIDONE
- SHELLAC
- SODIUM STARCH GLYCOLATE TYPE A POTATO
- STEARIC ACID
- SUCROSE
- TALC
- TITANIUM DIOXIDE
- DEACETYLBISACODYL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68210-0312 | 68210-0312-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9aa3a56c-543b-325b-e053-2995a90ae86e | 6290de48-f30b-4e8d-a974-eb2cfed1d09a | 2019-12-26 | Warnings | 9aa3a56c-543b-325b-e053-2995a90ae86e 6290de48-f30b-4e8d-a974-eb2cfed1d09a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.