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NDC 41163-0195-01 Laxative 5 mg/1 Details
Laxative 5 mg/1
Laxative is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by EQUALINE (SuperValu). 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: 41163-0195-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bisacodyl
Product Information
| NDC | 41163-0195 |
|---|---|
| Product ID | 41163-195_8db37ac7-8bcc-40a3-94f3-1884092b1a93 |
| 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 | 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 | EQUALINE (SuperValu) |
| 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 41163-0195-01 (41163019501)
| NDC Package Code | 41163-195-01 |
|---|---|
| Billing NDC | 41163019501 |
| Package | 1 BLISTER PACK in 1 CARTON (41163-195-01) / 100 TABLET, COATED in 1 BLISTER PACK |
| Marketing Start Date | 2013-03-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c97005c4-de11-4b4a-ae94-6e180b3490e4 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)
- it may cause stomach discomfort, faintness and cramps
- do not use within 1 hour after taking an antacid or milk
Directions
Inactive ingredients
acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 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 phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide
Principal Display Panel
compare to Dulcolax® active ingredient*
Gentle laxative
Bisacodyl USP 5 mg
overnight relief of constipation and irregularity
comfort coated tablets
*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of Dulcolax® Laxative.
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.
DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA
INGREDIENTS AND APPEARANCE
| LAXATIVE
ENTERIC COATED
bisacodyl tablet, coated |
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| Labeler - EQUALINE (SuperValu) (006961411) |