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NDC 61919-0085-60 BISACODYL ENTERIC 5 mg/1 Details
BISACODYL ENTERIC 5 mg/1
BISACODYL ENTERIC is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by DIRECT RX. 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: 61919-0085-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Bisacodyl
Product Information
| NDC | 61919-0085 |
|---|---|
| Product ID | 61919-085_494943af-f99a-4e24-e054-00144ff8d46c |
| Associated GPIs | 46200010000610 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | BISACODYL ENTERIC |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | BISACODYL ENTERIC |
| 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 | DIRECT RX |
| 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 | 2023-12-31 |
Package
Package Images
NDC 61919-0085-60 (61919008560)
| NDC Package Code | 61919-085-60 |
|---|---|
| Billing NDC | 61919008560 |
| Package | 60 TABLET, COATED in 1 BOTTLE (61919-085-60) |
| Marketing Start Date | 2017-02-24 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 494943af-f999-4e24-e054-00144ff8d46c Details
SPL UNCLASSIFIED SECTION
Do not use
Do not use if you cannot swallow without chewing
Ask a doctor before use if
-you have a sudden change in bowel habits that lasts more than 2 weeks
-stomach pain, nausea or vomiting
When using this product
-do not use within 1 hour after taking an antacid or milk
-do not chew or crush tablet(s)
-you may have stomach discomfort, faintness or cramps
Stop use and ask a doctor if
-you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
-you need to use a laxative for more than 1 week
Pregnancy/Breastfeeding
ask a health professions before use.
Keep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| BISACODYL ENTERIC
bisacodyl enteric tablet, coated |
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| Labeler - DIRECT RX (079254320) |
| Registrant - DIRECT RX (079254320) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| DIRECT RX | 079254320 | repack(61919-085) | |