FDA Label for Loperamide Hydrochloride And Simethicone
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH CAPLET)
- PURPOSES
- USES
- 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
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Loperamide Hydrochloride And Simethicone Product Label
The following document was submitted to the FDA by the labeler of this product Granules India Ltd. 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.
Other
Drug Facts
Active Ingredients (In Each Caplet)
Loperamide HCl, 2 mg
Simethicone, 125 mg
Purposes
Anti-diarrheal
Anti-gas
Uses
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 HCl
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 caplet
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 ag
- each caplet contains: calcium 148.40 mg, sodium 1.40 mg
- store between 20-25°C (68-77°F). Protect from light.
- for blister: do not use if blister unit is torn or broken
| 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 (60-95 lbs) | 1 caplet after the first loose stool;
½ caplet after each subsequent loose stool; but no more than 3 caplets in 24 hours |
| children 6-8 years (48-59 lbs) | 1 caplet after the first loose stool;
½ caplet after each subsequent loose stool; but no more than 2 caplets 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
Inactive Ingredients
acesulfame potassium, anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, flavor, microcrystalline cellulose, stearic acid.
Questions or comments?
Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST
Manufactured by:
Granules India Limited
Hyderabad-500 081, INDIA
MADE IN INDIA
Principal Display Panel
Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg
ANTI-DIARRHEAL / ANTI-GAS
Multi-Symptom Relief Caplet
Relieves symptoms of diarrhea plus
- Cramps & Pressure
- Bloating
- Gas
12 Caplets *
*capsule-shaped tablets
* Please review the disclaimer below.