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 A 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 The Kroger Co.. 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 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
- 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 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.
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 20°-25°C (68°-77°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?
1-800-632-6900
Principal Display Panel
COMPARE TO the active ingredient of IMODIUM® A-D *See side panel
Anti-Diarrheal
Loperamide HCI
Soft Gelatin Capsules 2 mg
CONTROLS THE SYMPTOMS OF DIARRHEA
Suitable for Adults and Children 12 Years and Over
SOFTGELS**
**each Liquid-Filled Capsule Contains 2 mg Loperamide HCI
*Imodium® A-D is a registered trademark of McNeil Consumer & Specialty Pharmaceuticals, Fort Washington, PA 19034, McNeil Consumer & Specialty Pharmaceuticals is not affiliated with The Kroger Co. or this product
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202
Product Label
KROGER Anti-Diarrheal
* Please review the disclaimer below.
