Active Ingredient (In Each Tablet)
Bisacodyl USP 5 mg
Proctozone-b Tablet, Coated
FDA Label NDC 57237-372
14 label sections · Submitted to the FDA by Rising Pharma Holdings, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rising Pharma Holdings, Inc. for the product Proctozone-b (NDC 57237-372). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulant laxative
Uses
● for relief of occasional constipation and irregularity
● this product generally produces bowel movement in 6 to 12 hours
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
* Please review the disclaimer below.
