Indications and uses
for relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours
Laxative
- Manufacturer
- GREENBRIER INTERNATIONAL, INC. | LNK International, Inc.
- Effective date
- 2023-04-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 9
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:24:52
Label at a glance#
ProductLaxative
Active ingredientBISACODYL
Label structure9 sections
Dosage and administration
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 store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid excessive humidity see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each tablet)
Bisacodyl USP, 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 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)
- do not use within 1 hour after taking an antacid or milk
- you may have stomach discomfort, faintness and cramps
Stop use and ask a doctor if
- 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,
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 (1-800-222-1222) right away.
Directions
- 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 |
Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- avoid excessive humidity
- see end flap for expiration date and lot number
Inactive ingredients
acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
Questions or comments?
1-800-426-9391
Principal display panel
COMPARE TO ACTIVE INGREDIENT IN
DULCOLAX® LAXATIVE TABLETS*
ASSURED™
Laxative
• Bisacodyl USP, 5 mg
Stimulant Laxative
Gentle, Dependable,
Constipation Relief
Actual Size
Comfort Coated
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 Sanofi-Aventis Deutschland GMBH, owner of the
registered trademark Dulcolax® Laxative Tablets.
50844 REV0119A32756
DISTRIBUTED BY:
GREENBRIER INTERNATIONAL, INC.
500 VOLVO PARKWAY
CHESAPEAKE, VA 23320
Products#
Every source-derived product name is available through these pages.
- Laxative
- Bisacodyl
- DEACETYLBISACODYL
- ACACIA
- AMMONIA
- CALCIUM CARBONATE
- CARNAUBA WAX
- SILICON DIOXIDE
- STARCH, CORN
- D&C YELLOW NO. 10 ALUMINUM LAKE
- FD&C YELLOW NO. 6
- HYPROMELLOSE, UNSPECIFIED
- FERROSOFERRIC OXIDE
- ANHYDROUS LACTOSE
- MAGNESIUM STEARATE
- METHYLPARABEN
- POLYDEXTROSE
- POLYETHYLENE GLYCOL, UNSPECIFIED
- Polyvinyl Acetate Phthalate
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- PROPYLPARABEN
- SHELLAC
- DIMETHICONE
- WATER
- SODIUM ALGINATE
- SODIUM BENZOATE
- SODIUM BICARBONATE
- STEARIC ACID
- SUCROSE
- TALC
- TITANIUM DIOXIDE
- TRIACETIN
- TRIETHYL CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 33992-0327 | 33992-0327-6 |
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 |
|---|---|---|---|---|---|---|
| 612cc479-ea96-4714-8f55-ae8e6a7cecae | f4367810-ea75-4f06-a3ab-3dfd02153234 | 2023-10-21 | Warnings | f4367810-ea75-4f06-a3ab-3dfd02153234 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.