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NDC 24689-0129-02 Bisacodyl 5 mg/1 Details
Bisacodyl 5 mg/1
Bisacodyl is a ORAL TABLET, DELAYED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Apnar Pharma LP. The primary component is BISACODYL.
Product Information
| NDC | 24689-0129 |
|---|---|
| Product ID | 24689-129_ec9edf75-b9cd-0b99-e053-2995a90a391f |
| Associated GPIs | |
| 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 |
| 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 | Apnar Pharma LP |
| 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 24689-0129-02 (24689012902)
| NDC Package Code | 24689-129-02 |
|---|---|
| Billing NDC | 24689012902 |
| Package | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (24689-129-02) |
| Marketing Start Date | 2022-11-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ec9edf75-b9cc-0b99-e053-2995a90a391f Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Do not use
- if you cannot swallow without chewing
Ask a doctor before use if you have:
- stomach pain, nausea, or vomiting
- noticed a sudden change in bowel habits that lasts more than 2 weeks
When using this product
- it may cause stomach discomfort, faintness and cramps
- do not chew or crush tablets(s)
- do not use within 1 hour after taking antacid or milk
Stop use and ask a doctor if
- you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
If pregnant or breast-feeding,
ask a health care professional before use.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Inactive ingredients
Lactose monohydrate, Anhydrous lactose, Pregelatinized starch, Magnesium stearate, Hypromellose, Triacetin, Talc, Methacrylic acid-ethyl acrylate copolymer (1:1) Type-A, Titanium dioxide, Triethyl citrate, D&C red no. 27, Colloidal anhydrous silica, Sodium bicarbonate, Sodium lauryl sulfate, FD&C blue no. 1, Carboxymethyl cellulose sodium, Maltodextrin, Dextrose monohydrate, Lecithin Soya.
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL
NDC 24689-129-02
Bisacodyl Delayed Release Tablets USP
5 mg- Pink
Stimulant Laxative
20 Tablets
NDC 24689-129-03
Bisacodyl Delayed Release Tablets USP
5 mg- Pink
Stimulant Laxative
100 Tablets
NDC 24689-129-04
Bisacodyl Delayed Release Tablets USP
5 mg- Pink
Stimulant Laxative
250 Tablets
NDC 24689-129-05
Bisacodyl Delayed Release Tablets USP
5 mg- Pink
Stimulant Laxative
500 Tablets
INGREDIENTS AND APPEARANCE
| BISACODYL
bisacodyl tablet, delayed release |
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| Labeler - Apnar Pharma LP (079568229) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Apnar Pharma Private Limited | 876730408 | manufacture(24689-129) , pack(24689-129) , analysis(24689-129) | |