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西药 · 美国药品标签原文

Sunmark Saline Single Laxative

SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM

Sunmark Saline Single Laxative · Strategic Sourcing Services LLC。此记录对应特定产品,标签收录不代表所有用途获批。

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spl product data elements

Sunmark Saline Single Laxative Sodium Phosphate, Dibasic and Sodium Phosphate, Monobasic, Unspecified Form SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM PHOSPHATE ION SODIUM CATION SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM PHOSPHATE ION SODIUM CATION BENZALKONIUM CHLORIDE EDETATE DISODIUM WATER

spl unclassified section

Drug Facts Distributed By Strategic Sourcing Services LLC 6555 State Highway 161, Irving, TX 75039

活性成分 / Active ingredient

Active ingredients (in each 118mL delivered dose) Purpose Dibasic Sodium Phosphate 7 g Saline laxative Monobasic Sodium Phosphate 19 g Saline laxative

active ingredient table

<table width="60%"><col width="75%" align="left" valign="top"/><col width="25%" align="right" valign="top"/><thead><tr><th><content styleCode="italics">Active ingredients (in each 118mL delivered dose)</content></th><th><content styleCode="italics">Purpose</content></th></tr></thead><tbody><tr><td>Dibasic Sodium Phosphate 7 g</td><td>Saline laxative</td></tr><tr><td>Monobasic Sodium Phosphate 19 g</td><td>Saline laxative</td></tr></tbody></table>

用途 / Purpose

Active ingredients (in each 118mL delivered dose) Purpose Dibasic Sodium Phosphate 7 g Saline laxative Monobasic Sodium Phosphate 19 g Saline laxative

purpose table

<table width="60%"><col width="75%" align="left" valign="top"/><col width="25%" align="right" valign="top"/><thead><tr><th><content styleCode="italics">Active ingredients (in each 118mL delivered dose)</content></th><th><content styleCode="italics">Purpose</content></th></tr></thead><tbody><tr><td>Dibasic Sodium Phosphate 7 g</td><td>Saline laxative</td></tr><tr><td>Monobasic Sodium Phosphate 19 g</td><td>Saline laxative</td></tr></tbody></table>

适应证 / Indications and usage

Use relieves occasional constipation this product generally produces bowel movement in 1 to 5 minutes

警告 / Warnings

Warnings Dosage warning Using more than one enema in 24 hours can be harmful. For rectal use only. Do not use on children under 2 years of age Ask a doctor before use if you have already used a laxative for more than 3 days have kidney disease, have heart problems, or are dehydrated are 55 years of age or older are on a sodium-restricted diet have abdominal pain, nausea, or vomiting have a sudden change in bowel habits lasting more than 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work. When using this product do not use more than directed. Serious side effects may occur from excess dosage do not use for more than 3 days, without asking a doctor Stop use and ask a doctor if you have rectal bleeding you have no bowel movement within 30 minutes of enema use you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

禁用事项 / Do not use

Do not use on children under 2 years of age

咨询医生 / Ask a doctor

Ask a doctor before use if you have already used a laxative for more than 3 days have kidney disease, have heart problems, or are dehydrated are 55 years of age or older are on a sodium-restricted diet have abdominal pain, nausea, or vomiting have a sudden change in bowel habits lasting more than 2 weeks

咨询医药人员 / Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

使用中 / When using

When using this product do not use more than directed. Serious side effects may occur from excess dosage do not use for more than 3 days, without asking a doctor

停用事项 / Stop use

Stop use and ask a doctor if you have rectal bleeding you have no bowel movement within 30 minutes of enema use you have symptoms of dehydration (thirstiness, dizziness, vomiting, urinating less often than normal) These symptoms may indicate a serious condition.

孕哺期 / Pregnancy or breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

儿童安全 / Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

用法用量原文 / Dosage and administration

Directions (or as directed by a doctor) Single daily dosage (per 24 hours) Do not use if taking another sodium phosphate product. Do not use more unless directed by a doctor. See Warnings . Adults and children 12 years of age and older 1 bottle once daily Children 2 to under 12 years of age Use Pediatric Enema Children under 2 years of age DO NOT USE

dosage and administration table

<table width="50%" styleCode="Noautorules"><col width="70%" align="center" valign="middle"/><col width="30%" align="center" valign="middle"/><tbody><tr styleCode="Botrule"><td styleCode="Toprule Rrule">Adults and children 12 years of age and older</td><td styleCode="Toprule">1 bottle once daily</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">Children 2 to under 12 years of age</td><td>Use Pediatric Enema</td></tr><tr><td styleCode="Rrule">Children under 2 years of age</td><td>DO NOT USE</td></tr></tbody></table>

储存 / Storage and handling

Other information each 118 ml contains sodium 4.3 g store at 15 to 30°C (59 to 86°F) additional liquids by mouth are recommended while using this product Tamper Evident: DO NOT USE IF TOP OR BOTTOM FLAP OF CARTON IS TORN OR MISSING.

辅料 / Inactive ingredients

Inactive ingredients benzalkonium chloride, disodium EDTA, purified water

questions

Questions or comments? 1-800-633-5463

package label principal display panel

PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton sunmark ® COMPARE TO FLEET® ENEMA SALINE ACTIVE INGREDIENTS* NDC 49348-186-20 complete & ready-to-use enema Saline Laxative For relief of occasional constipation Soft, flexible Comfort tip Pre-mixed LATEX FREE 4.5 FL OZ (133 ml) PRINCIPAL DISPLAY PANEL - 133 ml Bottle Carton

来源、版本与许可

资料类型
美国药品标签原文
版本
5 / 20260108
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