FDA Label for Loperamide Hydrochloride And Simethicone
View Indications, Usage & Precautions
- ACTIVE INGREDIENT(S)
- PURPOSES
- USE(S)
- 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 DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
Loperamide Hydrochloride And Simethicone Product Label
The following document was submitted to the FDA by the labeler of this product Camber Consumer Care 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(S)
(in each tablet)
Loperamide Hydrochloride USP 2 mg
Simethicone USP 125 mg
Purposes
Anti-diarrheal
Anti-gas
Use(S)
relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
Warnings
Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride
Heart alert: Taking more than directed can cause serious heart problems or death
Do Not Use
• if you have bloody or black stool
• if you have difficulty swallowing
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.
• you have difficulty swallowing the tablet
Otc - Pregnancy Or Breast Feeding
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
• take only on an empty stomach (1 hour before or 2 hours after a meal)
• take with a full (8 oz.) glass of water
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
| adults and children 12 years and over
| 2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours
|
children 9-11 years (60-95 lbs) | 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours
|
children 6-8 years (48-59 lbs) | 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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 tablet contains:
calcium 640 mg, very low sodium and potassium 5.838 mg
• store between 20 to 25°C (68 to 77°F). Protect from light.
• do not use if carton is open or if blister unit is open or torn
Inactive Ingredients
acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor
Questions Or Comments
call
1-888-588-1418
Distributed by:
Camber Consumer Care, Inc.
Piscataway, NJ 08854, USA.
Principal Display Panel
Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg-1x6's carton
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