FDA Label for Antidiarrheal Relief
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CAPLET)
- PURPOSE
- USE
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTORIF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- OTHER
- DIRECTIONS
- INACTIVE INGREDIENTS
- QUESTIONS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- ANTIDIARRHEAL LABEL
Antidiarrheal Relief Product Label
The following document was submitted to the FDA by the labeler of this product Honeywell Safety Products Usa, Inc. 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 Caplet)
Loperamide HCl USP 2 mg
Purpose
Antidiarrheal
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 attack: 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
Ask A Doctor Or Pharmacist Before Use If
you are taking antibiotics.
When Using This Product
- tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.
Stop Use And Ask A Doctorif
- diarrhea lasts for more than 2 days
- symptoms get worse
- you get abdominal swelling or bulging.
These may be signsor 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.
Other
Do not use if individual packet is torn or open.
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 (60-95Ibs) 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(48-59lbs) 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 under 6 years (up to 47 lbs) ask a doctor
Inactive Ingredients
anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow #10, FD&C blue #1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch
Questions?
call 1-800-430-5490
Package Label.Principal Display Panel
MM1
Antidiarrheal Label
* Please review the disclaimer below.