FDA Label for Leader Anti Diarrheal
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH 7.5 ML)
- PURPOSE
- USE
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Leader Anti Diarrheal Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health 110, Llc. Dba Leader. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient (In Each 7.5 Ml)
Loperamide HCl 1 mg
Purpose
Anti-diarrheal
Use
controls symptoms of diarrhea, including Travelers’ Diarrhea
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)
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 |
Other Information
• each 30 mL contains: sodium 15 mg• store between 20-25°C (68-77°F)
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
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
Anti-Diarrheal
Loperamide Hydrochloride Oral Solution, 1 mg per 7.5 mL
Anti-Diarrheal
Mint Flavor
COMPARE TO IMODIUM® A-D active ingredient
Controls the Symptoms of Diarrhea
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Anti-Diarrheal Oral Solution
SEE NEW WARNING AND DIRECTIONS
4 FL OZ (120 mL)
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