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NDC 49483-0003-10 STIMULANT LAXATIVE 5 mg/1 Details
STIMULANT LAXATIVE 5 mg/1
STIMULANT LAXATIVE is a ORAL TABLET, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by TIME CAP LABORATORIES, INC.. The primary component is BISACODYL.
MedlinePlus Drug Summary
Bisacodyl is used on a short-term basis to treat constipation. It also is used to empty the bowels before surgery and certain medical procedures. Bisacodyl is in a class of medications called stimulant laxatives. It works by increasing activity of the intestines to cause a bowel movement.
Related Packages: 49483-0003-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bisacodyl
Product Information
| NDC | 49483-0003 |
|---|---|
| Product ID | 49483-003_938bf8c5-6834-6362-e053-2995a90aa7e6 |
| Associated GPIs | 46200010000610 |
| GCN Sequence Number | 002947 |
| GCN Sequence Number Description | bisacodyl TABLET DR 5 MG ORAL |
| HIC3 | D6S |
| HIC3 Description | LAXATIVES AND CATHARTICS |
| GCN | 08762 |
| HICL Sequence Number | 001301 |
| HICL Sequence Number Description | BISACODYL |
| Brand/Generic | Generic |
| Proprietary Name | STIMULANT LAXATIVE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | BISACODYL |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, DELAYED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | BISACODYL |
| Labeler Name | TIME CAP LABORATORIES, INC. |
| Pharmaceutical Class | Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part334 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49483-0003-10 (49483000310)
| NDC Package Code | 49483-003-10 |
|---|---|
| Billing NDC | 49483000310 |
| Package | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (49483-003-10) |
| Marketing Start Date | 2018-12-07 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.03671 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | LAXATIVE EC 5 MG TABLET |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL e0a9f8d9-660b-431c-8043-6d8ec81f98e5 Details
SPL UNCLASSIFIED SECTION
Acadia, 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 Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warning: 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 two weeks.
When using this product: Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomach discomfort, faintness or cramps.
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| STIMULANT LAXATIVE
bisacodyl tablet, delayed release |
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| Labeler - TIME CAP LABORATORIES, INC. (037052099) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| TIME CAP LABORATORIES, INC. | 037052099 | manufacture(49483-003) | |