anti diarrheal LOPERAMIDE HYDROCHLORIDE REDPHARM DRUG INC FDA Approved Use controls symptoms of diarrhea, including Travelers’ Diarrhea
FunFoxMeds box
Route
ORAL
Applications
ANDA075232
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each caplet) Loperamide HCl 2 mg
Inactive Ingredients
Inactive ingredients anhydrous lactose carnauba wax D&C yellow no. 10 aluminum lake FD&C blue no. 1 aluminum lake hypromellose magnesium stearate microcrystalline cellulose polyethylene glycol pregelatinized starch
Strengths
2 mg
Treats Conditions
Use Controls Symptoms Of Diarrhea Including Travelers Diarrhea
Pill Appearance
Shape: oval Color: green Imprint: L2

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
77TI35393C
Packaging

Principal Display Panel See New Warnings Anti-Diarrheal Loperamide Hydrochloride Tablets, 2 mg Anti-Diarrheal Controls the Symptoms of Diarrhea Actual Size 12 CAPLETS* *Capsule-Shaped Tablets COMPARE TO active ingredient of IMODIUM ® A-D anti diarrheal image

Package Descriptions
  • Principal Display Panel See New Warnings Anti-Diarrheal Loperamide Hydrochloride Tablets, 2 mg Anti-Diarrheal Controls the Symptoms of Diarrhea Actual Size 12 CAPLETS* *Capsule-Shaped Tablets COMPARE TO active ingredient of IMODIUM ® A-D anti diarrheal image

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

Storage & Handling

Other information store at 20 ° -25 ° C (68 ° -77 ° F) see end panel for lot number and expiration date

Questions

Questions or comments? 1-800-719-9260


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