Anti-Diarrheal LOPERAMIDE HYDROCHLORIDE SDA LABORATORIES, INC. FDA Approved Use Controls symptoms of diarrhea, including Travelers' Diarrhea
FunFoxMeds box
Route
ORAL
Applications
ANDA076497
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Loperamide HCl 2 mg
Inactive Ingredients
Inactive ingredients corn starch D&C yellow #10 aluminum lake dibasic calcium phosphate dihydrate FD&C blue#1 brilliant blue magnesium stearate microcrystalline cellulose silica gel
Strengths
2 mg
Treats Conditions
Use Controls Symptoms Of Diarrhea Including Travelers Diarrhea
Pill Appearance
Shape: oval Color: green Imprint: 44;375

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UPC
0266424725244
UNII
77TI35393C
Packaging

Principal Display Panel NDC 66424-725-24 Compare to the active ingredient in Imodium ® A-D † Anti-Diarrheal Loperamide Hydrocholoride Caplets, 2 mg Controls Symptoms of Diarrhea 24 Caplets † This product is not manufactured or distributed by the owner of the registered trademark Imodium ® A-D. label

Package Descriptions
  • Principal Display Panel NDC 66424-725-24 Compare to the active ingredient in Imodium ® A-D † Anti-Diarrheal Loperamide Hydrocholoride Caplets, 2 mg Controls Symptoms of Diarrhea 24 Caplets † This product is not manufactured or distributed by the owner of the registered trademark Imodium ® A-D. label

Overview

Use Controls symptoms of diarrhea, including Travelers' Diarrhea

Indications & Usage

Use Controls symptoms of diarrhea, including Travelers' Diarrhea

Dosage & 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

Warnings & Precautions
Warnings Allergy alert: Do not use if you have ever had a rash or other allergic reaction to Loperamide HCl. 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 in the stool a history of liver disease a history of abnormal heart rhythm Ask a doctor 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 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 (1-800-222-1222) right away.
Purpose

Purpose Anti-diarrheal

Do Not Use

Do not use: if you have bloody or black stool.

When Using

When using this product tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

Stop Use & Ask a Doctor

Stop use and ask a doctor if symptoms get worse diarrhea lasts more than 2 days you get abdominal swelling or bulging. These may be signs of a serious condition.

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 (1-800-222-1222) right away.

Storage & Handling

Other information THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPER EVIDENT PACKAGE: USE ONLY IF BLISTERS ARE INTACT do not use if blister unit is torn or open store at 20°-25°C (68°-77°F) KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. see end flap for expiration date and lot number

Questions

Questions? call toll-free 1-866-933-6337


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