FDA Label for Loperamide Hcl And Simethicone
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS (IN EACH CAPLET)
- PURPOSES
- USES
- ALLERGY ALERT:
- 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?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Loperamide Hcl And Simethicone Product Label
The following document was submitted to the FDA by the labeler of this product Ohm Laboratories 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 Ingredients (In Each Caplet)
Loperamide HCl USP, 2 mg
Simethicone USP, 125 mg
Purposes
Anti-diarrheal
Anti-gas
Uses
relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas
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 (1800-222-1222).
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 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; 1/2 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; 1/2 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 (upto 33 lbs) | do not use |
Other Information
• calcium: contains 142 mg/caplet• store between 20-25° C (68-77° F). Protect from light.• TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.
Inactive Ingredients
calcium silicate, colloidal silicon dioxide, dibasic calcium phosphate, microcrystalline cellulose, sodium starch glycolate, stearic acid
Questions?
call 1-800-406-7984
Package/Label Principal Display Panel
NDC 51660-069-03
See New Warnings and Directions
ohm
Loperamide HCl and Simethicone Tablets, 2 mg/125 mg
Anti-Diarrheal/Anti-Gas
Multi-Symptom Relief
Relieves symptoms of diarrhea plus
• Cramps & Pressure• Bloating• Gas
6 Caplets* (*capsule-shaped tablets)
Keep the carton. It contains important information.
Manufactured by:
Sun Pharmaceutical Industries Limited,
MOHALI, INDIA
Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901
0721
* Please review the disclaimer below.