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| Product NDC Code | 24689-129 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Bisacodyl |
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| Type | Generic | ||||||||||
| Pharm Class | Increased Large Intestinal Motility [PE], Stimulant Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||
| Dosage Form | TABLET, DELAYED RELEASE | ||||||||||
| RxCUI drug identifier | 308753 | ||||||||||
| Application Number | part334 | ||||||||||
| Labeler Name | Apnar Pharma LP | ||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Bisacodyl (USP) 5 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions take with glass of water adult and children 12 years of age and over- 1 to 3 tablets in a single daily dose children 6 to under 12 years of age- 1 tablet in a single daily dose children under 6 years of age- ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses for relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours
Purpose
Information about the drug product’s indications for use.Purpose Stimulant laxative
Spl product data elements
Usually a list of ingredients in a drug product.Bisacodyl Bisacodyl DEXTROSE MONOHYDRATE TRIACETIN D&C RED NO. 27 MALTODEXTRIN METHACRYLIC ACID-ETHYL ACRYLATE COPOLYMER (1:1) TYPE A LACTOSE MONOHYDRATE ANHYDROUS LACTOSE TALC SILICON DIOXIDE TITANIUM DIOXIDE TRIETHYL CITRATE BISACODYL DEACETYLBISACODYL STARCH, CORN SODIUM BICARBONATE SODIUM LAURYL SULFATE FD&C BLUE NO. 1 CARBOXYMETHYLCELLULOSE SODIUM MAGNESIUM STEARATE HYPROMELLOSES LECITHIN, SOYBEAN F
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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 NDC 24689-129-02 Bisacodyl Delayed Release Tablets USP 5 mg- Pink 20 Tablets 300072 Bisacodyl DR Tablets - 5 mg -100s count label Bisacodyl DR Tablets - 5 mg -250s count label Bisacodyl DR Tablets - 5 mg -500s count label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Distributed By: APNAR PHARMA LP CHINO, CA, 91710 Rev.: 07/2022 Compare to Dulcolax Pink ® active ingredient* *This product is not maufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark of Dulcolax Pink ®
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-855-642-2594
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at 15º-30ºC (59º - 86º F).
Boxed warning
Information about contraindications or serious warnings, particularly those that may lead to death or serious injury.Caution: Do not use if imprinted seal under cap is broken or missing.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API