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spl product data elements
Anti-Diarrheal Loperamide HCl STARCH, CORN D&C YELLOW NO. 10 FD&C BLUE NO. 1 MAGNESIUM STEARATE SILICON DIOXIDE LOPERAMIDE HYDROCHLORIDE LOPERAMIDE CELLULOSE, MICROCRYSTALLINE DIBASIC CALCIUM PHOSPHATE DIHYDRATE 44375 light green
活性成分 / Active ingredient
Active ingredient(in each caplet) Loperamide HCI 2 mg
用途 / Purpose
Purpose Anti-diarrheal
适应证 / Indications and usage
Uses controls symptoms of diarrhea, including Travelers' Diarrhea
警告 / Warnings
Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCI Heart alert: Taking more than directed can cause serious heart problems or death. Do not use if you have bloody or black stool Ask a doctor before use if you have a fever mucus present in your stool a history of liver disease a history of abnormal heart rhythm Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs. When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery. Stop use and ask a doctor if diarrhea lasts for more than 2 days symptoms get worse you get abdominal swelling or bulging. These may 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 drink plenty of clear fluids to help prevent dehydration caused by diarrhea find right dose on chart. If possible, use weight to dose; otherwise, use age. adults and children 12 years and over 2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours children 9-11 years (60-95 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours children 6-8 years (48-59 lbs) 1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children 2-5 years (34-47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use
dosage and administration table
<table border="1"><tbody><tr><td>adults and children 12 years and over </td><td>2 caplets after the first loose stool; 1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours </td></tr><tr><td>children 9-11 years (60-95 lbs)</td><td>1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours </td></tr><tr><td>children 6-8 years (48-59 lbs)</td><td>1 caplet after the first loose stool; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours </td></tr><tr><td>children 2-5 years (34-47 lbs)</td><td>ask a doctor</td></tr><tr><td>children under 2 years (up to 33 lbs)</td><td>do not use</td></tr></tbody></table>
储存 / Storage and handling
Other Information each caplet contains: calcium 15 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 20⁰C-25⁰C (68⁰F-77⁰F) see end flap for expiration date and lot number
辅料 / Inactive ingredients
Inactive Ingredients corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, silicon dioxide Questions or comments? call 1-800-540-3765
questions
Questions or comments? call 1-800-540-3765
package label principal display panel
package Label 1
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 7 / 20250611
- 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.

