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NDC 50804-0190-03 Bisacodyl Laxative 5 mg/1 Details
Bisacodyl Laxative 5 mg/1
Bisacodyl Laxative is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Good Sense (Geiss, Destin & Dunn, 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: 50804-0190-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bisacodyl
Product Information
| NDC | 50804-0190 |
|---|---|
| Product ID | 50804-190_d8b6d34f-daaf-4f9c-8f08-e5e75e8c6c63 |
| 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 | Bisacodyl Laxative |
| Proprietary Name Suffix | Enteric Coated |
| Non-Proprietary Name | Bisacodyl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | BISACODYL |
| Labeler Name | Good Sense (Geiss, Destin & Dunn, 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 | n/a |
Package
Package Images
NDC 50804-0190-03 (50804019003)
| NDC Package Code | 50804-190-03 |
|---|---|
| Billing NDC | 50804019003 |
| Package | 1 BLISTER PACK in 1 CARTON (50804-190-03) / 25 TABLET, COATED in 1 BLISTER PACK |
| Marketing Start Date | 2010-07-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 0f51f7e9-370e-4c19-8a45-0ae5ccfd4275 Details
Use
Warnings
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
- it may cause stomach discomfort, faintness and cramps
Directions
Inactive ingredients
acacia, 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, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide
Principal Display Panel
Overnight Relief
Bisacodyl Laxative
Gentle, Predictable
Overnight Relief
Enteric Coated Tablets (5 mg Each)
*Compare to active ingredient in Dulcolax®
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of Dulcolax® Laxative.
Distributed by:
Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
Product of U.S.A.
INGREDIENTS AND APPEARANCE
| BISACODYL LAXATIVE
ENTERIC COATED
bisacodyl tablet, coated |
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| Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836) |