loperamide hydrochloride LOPERAMIDE HCL RITE AID CORPORATION FDA Approved Use controls symptoms of diarrhea, including Travelers’ Diarrhea
FunFoxMeds box
Route
ORAL
Applications
ANDA091292

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 7.5 mL) Loperamide HCl 1 mg
Inactive Ingredients
Inactive ingredients anhydrous citric acid carboxymethylcellulose sodium D&C yellow no. 10 FD&C blue no. 1 glycerin microcrystalline cellulose natural and artificial mint flavor propylene glycol purified water simethicone sodium benzoate sucralose titanium dioxide xanthan gum
Strengths
7.5 ml 1 mg
Quantities
5 ml 240 ml
Treats Conditions
Use Controls Symptoms Of Diarrhea Including Travelers Diarrhea
Pill Appearance
Color: green

Identifiers & Packaging

Container Type UNKNOWN
UNII
77TI35393C
Packaging

Package/Label Principal Display Panel Compare to the active ingredient in Imodium ® A-D LOPERAMIDE HYDROCHLORIDE Oral Solution, 1 mg per 7.5 mL ANTI-DIARRHEAL Controls the symptoms of diarrhea Anti-Diarrheal Oral Solution MINT FLAVOR 8 FL OZ (240 mL) loperamide-pdp loperamide-dfl1 loperamide-dfl2

Package Descriptions
  • Package/Label Principal Display Panel Compare to the active ingredient in Imodium ® A-D LOPERAMIDE HYDROCHLORIDE Oral Solution, 1 mg per 7.5 mL ANTI-DIARRHEAL Controls the symptoms of diarrhea Anti-Diarrheal Oral Solution MINT FLAVOR 8 FL OZ (240 mL) loperamide-pdp loperamide-dfl1 loperamide-dfl2

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. • shake well before using • use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device. • mL = milliliter adults and children 12 years and over 30 mL after the first loose stool; 15 mL after each subsequent loose stool; but no more than 60 mL in 24 hours children 9-11 years (60-95 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 45 mL in 24 hours children 6-8 years (48-59 lbs) 15 mL after the first loose stool; 7.5 mL after each subsequent loose stool; but no more than 30 mL 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 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

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 • each 30 mL contains: sodium 15 mg • store between 20-25 ° C (68-77 ° F)

Questions

Questions or comments? 1-800-719-9260


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