Other
Drug Facts
Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
CODE NO.: MH/DRUGS/25-KD/724
Issued: 09/2024
Proctozone-b Suppository
FDA Label NDC 57237-337
Full FDA labeling including 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 57237-337). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each suppository)
Bisacodyl USP, 10 mg
Otc - Purpose
Purpose
Stimulant Laxative
Indications & Usage
Use
- for relief of occasional constipation (irregularity)
- this product generally produces bowel movement in 15 minutes to 1 hour
Warnings
Warnings
For rectal use only
Otc - Ask Doctor
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
Otc - When Using
When using this product you may experience stomach discomfort, faintness, rectal burning and mild cramps
Otc - Stop Use
Stop use and ask a doctor if
- you need to use a laxative product for longer than one week
- you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
adults and children 12 years of age and over | 1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes |
| children 6 to under 12 years | 1/2 suppository in a single daily dose |
| children under 6 years | Do not use |
Storage And Handling
Other information
- store at 20-25°C (68-77°F)
- if suppository softens prior to use, may be placed in refrigerator for short time
Inactive Ingredient
Inactive ingredient hard fat
Otc - Questions
Questions or Comments: Call 1-844-474-7464
Other Safety Information
TAMPER EVIDENT, INDIVIVIDUALLY SEALED FOR YOUR PROTECTION
Package Label.Principal Display Panel
NDC 57237-337-21 (3 blisters of 4 suppositories)
Proctozone-BTM
Bisacodyl (USP) 10 mg Suppositories
MEDICATED LAXATIVE SUPPOSITORY
Gentle, Predictable Relief
DO NOT SWALLOW
Proctozone-b-supp-01 (Proctozone B Supp 01) 
NDC 57237-337-04 (4 suppositories in 1 blister pack)
Front Foil
Proctozone-b-supp-02 (Proctozone B Supp 02) 
NDC 57237-337-04 (4 suppositories in 1 blister pack)
Back Foil
Proctozone-b-supp-03 (Proctozone B Supp 03) 
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