Med SciforuMed Sciforu

Interface in English. Medical references retain their original language; bilingual names and selected translations are provided.

西药 · 美国药品标签原文

比沙可啶 · stimulant laxative enteric coated

BISACODYL

stimulant laxative enteric coated · Aphena Pharma Solutions - Tennessee, LLC。此记录对应特定产品,标签收录不代表所有用途获批。

说明与适用边界

此页按所列地区、版本归档。标签内容可能更新,具体产品请核对原始来源;本站关联表示阅读线索,不表示药品与器械可兼容或可替换。

spl product data elements

stimulant laxative enteric coated Bisacodyl ACACIA AMMONIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN D&C YELLOW NO. 10 FD&C YELLOW NO. 6 HYPROMELLOSES FERROSOFERRIC OXIDE LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHYLPARABEN POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ACETATE PHTHALATE PROPYLPARABEN PROPYLENE GLYCOL POVIDONE SHELLAC DIMETHICONE SILICON DIOXIDE SODIUM ALGINATE SODIUM BENZOATE SODIUM BICARBONATE STEARIC ACID SUCROSE TALC TITANIUM DIOXIDE TRIACETIN TRIETHYL CITRATE BISACODYL DEACETYLBISACODYL 5

活性成分 / Active ingredient

Active ingredient (in each tablet) Bisacodyl 5 mg

用途 / Purpose

Purpose Stimulant Laxative

适应证 / Indications and usage

Uses relieves occasional constipation and irregularity generally produces a bowel movement in 6 to 12 hours

警告 / Warnings

Warnings Do not use • for more than one week unless directed by a doctor • if you cannot swallow without chewing • within 1 hour after taking an antacid or milk Ask a doctor before use if you have • abdominal pain • nausea • vomiting • a sudden change in bowel habits that lasts longer than 2 weeks When using this product • abdominal discomfort, faintness, or cramps may occur Stop use and ask a doctor • if you have no bowel movement within 12 hours • if you have rectal bleeding • these could be signs of a serious condition 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.

儿童安全 / 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.

用法用量原文 / Dosage and administration

Directions • do not take more than directed • swallow whole, do not chew or crush • take recommended dose in a single daily dose • take with water • adults and children 12 years and older: take 1-3 (usually 2) tablets daily • children 12 and under: ask a doctor

储存 / Storage and handling

Other information • store at room temperature • avoid excessive humidity • Tamper Evident: Do not use if imprinted seal under cap is missing or broken • package not child resistant • for institutional use only

辅料 / Inactive ingredients

Inactive ingredients Acacia, Ammonium Hydroxide, Calcium Carbonate, Corn Starch, D and C Yellow NO. 10 Lake, FD and C Yellow NO. 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. May also contain: Calcium Sulfate, Gelatin, Sodium Starch Glycolate.

spl unclassified section

Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 5 mg 2 71610-453-02 4 71610-453-04 20 71610-453-20 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20200805JH Aphena Pharma Solutions - TN

spl unclassified section table

<table border="0" cellpadding="1" cellspacing="1" width="28%"><col width="10%"/><col/><tbody><tr styleCode="Toprule"><td align="center" styleCode="bold" valign="bottom">Count</td><td align="center" valign="bottom"><content styleCode="bold">5 mg</content></td></tr><tr><td align="center" valign="bottom">2</td><td align="center">71610-453-02</td></tr><tr><td align="center" valign="bottom">4</td><td align="center">71610-453-04</td></tr><tr><td align="center" valign="bottom">20</td><td align="center">71610-453-20</td></tr></tbody></table>

package label principal display panel

PRINCIPAL DISPLAY PANEL - 5 mg NDC 71610-453 - Bisacodyl 5 mg Tablets Bottle Label 5 mg

来源、版本与许可

资料类型
美国药品标签原文
版本
4 / 20250109
获取时间
2026-10-08
许可
openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.
核对原始来源