Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
equate diarrhea control
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package/Label Principal Display Panel
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equate™
Compare to Imodium® A-D active ingredient
DIARRHEA CONTROL
Loperamide Hydrochloride Oral Solution, 1mg per 7.5 mL
Anti-Diarrheal
FOR AGES 6 YEARS AND UP
Controls the Symptoms of Diarrhea
Anti-Diarrheal Oral Solution
Mint Flavor
4 FL OZ (118mL)
INDICATIONS & USAGE SECTION
Use
controls symptoms of diarrhea, including Travelers’ Diarrhea
DOSAGE & ADMINISTRATION SECTION
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 SECTION
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)
STORAGE AND HANDLING SECTION
Other information
•
**each 30 mL contains:** sodium 15 mg
•
store between 20-25°C (68-77°F)
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each 7.5 mL)
Loperamide HCl 1 mg
OTC - PURPOSE SECTION
Purpose
Anti-diarrheal
OTC - QUESTIONS SECTION
Questions or comments?
1-888-287-1915
INACTIVE INGREDIENT SECTION
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