FDA Label for Anti-diarrheal
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH CAPSULE)
- 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 DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
- PRODUCT LABEL
Anti-diarrheal Product Label
The following document was submitted to the FDA by the labeler of this product Good Sense (geiss, Destin & Dunn, 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 Capsule)
Loperamide HCI 2 mg
Purpose
Anti- diarrheal
Use
controls symptoms of diarrhea, including Traveler's 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
- in children under 12 years of age
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 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.
Directions
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- not for use in children under 12 years of age
- adults and children 12 years of age and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours
Other Information
- store at 20o-25oC (68o-77o F). Protect from light
- avoid excessive heat above 40°C (104°F)
- do not use if carton or blister unit is open or torn
- see side panel for lot number and expiration date
Inactive Ingredients
butylated hydroxyanisole, edible ink, FD&C Blue #1, gelatin, glycerin, glyceryl caprylate, polyoxyl 40 hydrogenated castor oil, purified water.
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Liquid-Filled Softgels
Anti-Diarrheal
Soft Gelatin Capsules, 2 mg
Loperamide HCl
Controls the symptoms of diarrhea
Suitable for adults and children 12 years and over
SOFTGELS*
*each liquid- filled capsule contains 2 mg Loperamide HCl
**Compare to active ingredient in Imodium® A-D
THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
**This product is not manufactured or distributed by McNeil Consumer and Specialty Pharmaceuticals, distributor of Imodium® A-D.
Distributed by:
Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
Product Label
GoodSense Anti-Diarrheal Soft Gelatin Capsule
* Please review the disclaimer below.