Indications and uses
● for relief of occasional constipation and irregularity ● this product generally produces bowel movement in 6 to 12 hours
Proctozone-B - Rising Pharma Holdings, Inc. | Elysium Pharmaceuticals Ltd
- Manufacturer
- Rising Pharma Holdings, Inc. | Elysium Pharmaceuticals Ltd
- Effective date
- 2026-09-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-10-13 04:03:17
Label at a glance#
ProductProctozone-B
Active ingredientBISACODYL
Label structure10 sections
Dosage and administration
take with a glass of water adults and children 12 years of age 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
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 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
● noticed a sudden change in bowel habits that lasts more than 2 weeks
When using this product
● it may cause stomach discomfort, faintness and cramps
● do not chew or crush tablet(s)
● do not use within 1 hour after taking an antacid or milk
Stop use and ask a doctor if
● you have rectal bleeding or fail to have a 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 of age 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
● contains FD&C yellow No. 6
● store at 20°-25°C (68°-77°F)
● protect from excessive humidity
Inactive ingredients
colloidal silicon dioxide, D&C Yellow 10, FD&C Yellow 6, hypromellose-5, magnesium stearate, maltodextrin, methacrylic acid, microcrystalline cellulose, PEG 400, purified water, sodium starch glycolate, talc, titanium dioxide, triethyl citrate
Questions or comments?
call 1-844-474-7464
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
MFG LIC No.: G/25/2258
Issued: 05/2026
S-112-00
PROCTOZONE-BTM
PRINCIPAL DISPLAY PANEL
Proctozone-BTM
Bisacodyl Tablets, USP 5 mg
Stimulant Laxative
ORAL
OVERNIGHT LAXATIVE
100 ENTERIC-COATED TABLETS
Products#
Every source-derived product name is available through these pages.
- Proctozone-B
- Bisacodyl
- DEACETYLBISACODYL
- SILICON DIOXIDE
- D&C YELLOW NO. 10
- FD&C YELLOW NO. 6
- HYPROMELLOSE 2910 (5 MPA.S)
- MAGNESIUM STEARATE
- MALTODEXTRIN
- METHACRYLIC ACID
- MICROCRYSTALLINE CELLULOSE
- POLYETHYLENE GLYCOL 400
- WATER
- SODIUM STARCH GLYCOLATE TYPE A
- TALC
- TITANIUM DIOXIDE
- TRIETHYL CITRATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57237-372 | 57237-372-01 |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.