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| Product NDC Code | 71335-1531 | ||||||||||||||||||||||
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| Drug Name | Stimulant laxative enteric coated |
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| Type | Brand | ||||||||||||||||||||||
| 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 | ||||||||||||||||||||||
| RxCUI drug identifier | 308753 | ||||||||||||||||||||||
| Application Number | 505G(a)(3) | ||||||||||||||||||||||
| Labeler Name | Bryant Ranch Prepack | ||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Bisacodyl 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 a glass of water adults and children 12 years and older: take 1 to 3 tablets in a single daily dose children 12 and under: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acacia, ammonium hydroxide, calcium carbonate, corn starch, D&C yellow #10 lake, FD&C yellow #6 lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, PEG, polydextrose, polyvinyl acetate phthalate, propylparaben, propylene glycol, povidone, shellac, simethicone, silica, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate, wax.
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.stimulant laxative enteric coated Bisacodyl SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE BISACODYL DEACETYLBISACODYL ACACIA AMMONIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED FERROSOFERRIC OXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHYLPARABEN POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ACETATE PHTHALATE PROPYLPARABEN PROPYLENE GLYCOL POVIDONE, UNSPECIFIED SHELLAC DIMETHICONE SILICON DIOXIDE 5
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.Bisacodyl 5mg Tablet Label
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? 1-800-540-3765
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED NDC: 71335-1531-0: 25 Tablets in a BOTTLE NDC: 71335-1531-1: 30 Tablets in a BOTTLE NDC: 71335-1531-2: 2 Tablets in a BOTTLE NDC: 71335-1531-3: 3 Tablets in a BOTTLE NDC: 71335-1531-4: 4 Tablets in a BOTTLE NDC: 71335-1531-5: 10 Tablets in a BOTTLE NDC: 71335-1531-6: 90 Tablets in a BOTTLE NDC: 71335-1531-7: 8 Tablets in a BOTTLE NDC: 71335-1531-8: 100 Tablets in a BOTTLE NDC: 71335-1531-9: 20 Tablets in a BOTTLE Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
Storage and handling
Information about safe storage and handling of the drug product.Other information • Tamper Evident: Do not use if imprinted seal under cap is missing or broken • store at room temperature 15°-30°C (59°-86°F) • avoid excessive humidity • package not child resistant
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, vomiting • noticed 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 Stop use and ask a doctor if • you have rectal bleeding or no 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 professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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