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| Product NDC Code | 71335-1754 | ||||||||||||||||||||||
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| Drug Name | Gentle laxative |
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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, DELAYED RELEASE | ||||||||||||||||||||||
| RxCUI drug identifier | 308753 | ||||||||||||||||||||||
| Application Number | 505G(a)(3) | ||||||||||||||||||||||
| Labeler Name | Bryant Ranch Prepack | ||||||||||||||||||||||
| 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 a glass of water adults and children 12 years and over take 1 to 3 tablets in a single daily dose children 6 to under 12 years take 1 tablet in a single daily dose children under 6 years ask a doctor
| adults and children 12 years and over | take 1 to 3 tablets in a single daily dose |
| children 6 to under 12 years | take 1 tablet in a single daily dose |
| children under 6 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate
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.gentle laxative Bisacodyl BISACODYL DEACETYLBISACODYL ACACIA AMMONIA CALCIUM CARBONATE CARNAUBA WAX SILICON DIOXIDE STARCH, CORN D&C YELLOW NO. 10 ALUMINUM LAKE FD&C YELLOW NO. 6 HYPROMELLOSE, UNSPECIFIED FERROSOFERRIC OXIDE ANHYDROUS LACTOSE MAGNESIUM STEARATE METHYLPARABEN POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ACETATE PHTHALATE POVIDONE, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN SHELLAC DIMETHICONE WATER SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE 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
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you cannot swallow without chewing.
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? 1-800-426-9391
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not chew or crush tablet(s) do not use within 1 hour after taking an antacid or milk you may have stomach discomfort, faintness and cramps
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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: 71335-1754-0: 25 Tablets in a BLISTER PACK NDC: 71335-1754-1: 30 Tablets in a BLISTER PACK NDC: 71335-1754-2: 2 Tablets in a BLISTER PACK NDC: 71335-1754-3: 3 Tablets in a BLISTER PACK NDC: 71335-1754-4: 4 Tablets in a BLISTER PACK NDC: 71335-1754-5: 10 Tablets in a BLISTER PACK NDC: 71335-1754-6: 90 Tablets in a BLISTER PACK NDC: 71335-1754-7: 8 Tablets in a BLISTER PACK NDC: 71335-1754-8: 100 Tablets in a BLISTER PACK NDC: 71335-1754-9: 20 Tablets in a BLISTER PACK
Storage and handling
Information about safe storage and handling of the drug product.Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid excessive humidity see end flap for expiration date and lot number
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 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 you may have stomach discomfort, faintness and 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 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