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spl product data elements
Loperamide Hydrochloride Loperamide Hydrochloride ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM CROSPOVIDONE (15 MPA.S AT 5%) D&C YELLOW NO. 10 FD&C BLUE NO. 1 HYDROGENATED COTTONSEED OIL MAGNESIUM STEARATE POWDERED CELLULOSE STARCH, CORN LOPERAMIDE HYDROCHLORIDE LOPERAMIDE shaped tablet 123
spl unclassified section
Drug Facts
Distributed by ZEE MEDICAL, INC., Irvine, CA 92606
活性成分 / Active ingredient
Active ingredient (in each caplet) Loperamide Hydrochloride USP, 2 mg
用途 / Purpose
Purpose Anti-diarrheal
适应证 / Indications and usage
Use 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 hydrochloride 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 fever mucus in the 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 symptoms get worse diarrhea lasts for more than 2 days 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 (1-800-222-1222).
禁用事项 / Do not use
Do not use if you have bloody or black stool
咨询医生 / Ask a doctor
Ask a doctor before use if you have fever mucus in the stool a history of liver disease a history of abnormal heart rhythm
咨询医药人员 / Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.
使用中 / When using
When using this product tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
停用事项 / Stop use
Stop use and ask a doctor if symptoms get worse diarrhea lasts for more than 2 days you get abdominal swelling or bulging. These may be signs of 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. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
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; ½ 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; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours children 2-5 years (34 to 47 lbs) ask a doctor children under 2 years (up to 33 lbs) do not use
dosage and administration table
<table width="55%" styleCode="Noautorules"><col width="25%" align="left" valign="top"/><col width="75%" align="left" valign="top"/><tbody><tr styleCode="Botrule"><td styleCode="Toprule Rrule">adults and children 12 years and over</td><td styleCode="Toprule">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 styleCode="Botrule"><td styleCode="Rrule">children 9-11 years (60-95 lbs)</td><td>1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">children 6-8 years (48-59 lbs)</td><td>1 caplet after the first loose stool; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours</td></tr><tr styleCode="Botrule"><td styleCode="Rrule">children 2-5 years (34 to 47 lbs)</td><td>ask a doctor</td></tr><tr><td styleCode="Rrule">children under 2 years (up to 33 lbs)</td><td>do not use</td></tr></tbody></table>
储存 / Storage and handling
Other information store between 20° – 25°C (68° – 77°F) see side panel for lot number and expiration date TAMPER EVIDENT: THIS PRODUCT IS PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.
辅料 / Inactive ingredients
Inactive ingredients anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch
questions
Questions? Call toll-free Monday-Friday 8:30 am to 5 pm EST at 1800-406-7984 .
package label principal display panel
PRINCIPAL DISPLAY PANEL - 2 mg Caplet Blister Pack Carton COMPARE TO THE ACTIVE INGREDIENT IN IMODIUM ® A-D** ZEE ® Loperamide Hydrochloride Tablets USP, 2 mg Anti-Diarrheal See New Warnings and Directions 12 Caplets* Each caplet (*capsule-shaped tablet) contains Loperamide Hydrochloride USP, 2 mg Controls the Symptoms of Diarrhea PRINCIPAL DISPLAY PANEL - 2 mg Caplet Blister Pack Carton
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 4 / 20240111
- 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.

