CareOne Diarrhea Control LOPERAMIDE HYDROCHLORIDE AMERICAN SALES COMPANY FDA Approved Use controls symptoms of diarrhea, including Travelers’ Diarrhea
FunFoxMeds bottle
Route
ORAL
Applications
ANDA091292
Package NDC

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 120 ml
Treats Conditions
Use Controls Symptoms Of Diarrhea Including Travelers Diarrhea
Pill Appearance
Color: green

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UNII
77TI35393C
Packaging

Package/Label Principal Display Panel CAREone ® Compare to the active ingredient in Imodium® A-D Anti-Diarrheal Oral Solution For Ages 6 Years And Up DIARRHEA CONTROL Loperamide Hydrochloride Oral Solution, 1 mg per 7.5 mL/Anti Diarrheal Controls the symptoms of diarrhea Mint Flavor Anti-Diarrheal Oral Solution See New Warnings and Directions 4 FL OZ (120mL) careone-diarrhea-control-mint-container-image.jpg

Package Descriptions
  • Package/Label Principal Display Panel CAREone ® Compare to the active ingredient in Imodium® A-D Anti-Diarrheal Oral Solution For Ages 6 Years And Up DIARRHEA CONTROL Loperamide Hydrochloride Oral Solution, 1 mg per 7.5 mL/Anti Diarrheal Controls the symptoms of diarrhea Mint Flavor Anti-Diarrheal Oral Solution See New Warnings and Directions 4 FL OZ (120mL) careone-diarrhea-control-mint-container-image.jpg

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
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 • 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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