FDA Label for Loperamide Hydrochloride And Simethicone
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS (IN EACH CAPLET)
- PURPOSES
- USES
- ALLERGY ALERT
- HEART ALERT
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - 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 Bionpharma 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.
Other
Drug Facts
***All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Imodium ® Multi-Symptom Relief
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.
Manufactured for:
BIONPHARMA
600 Alexander Road,
Princeton, NJ 08540
MADE IN INDIA
Rev # 09/19
L0000000
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.
Otc - When Using
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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 caplets after the first loose stool;
1 caplet after each subsequent loose stool; but no more than 4 caplets in 24 hours |
children 9 years to 11 years
(60 lbs to 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 years to 8 years
(48 lbs to 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 years to 5 years
(34 lbsto 47 lbs) | ask a doctor |
children under 2 years
(up to 33 lbs) | do not use |
Other Information
- each caplet contains: calcium 155 mg, sodium 3 mg
- store between 20° to 25°C (68° to 77°F). Protect from light.
Inactive Ingredients
acesulfame potassium, anhydrous dicalcium phosphate, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, vanilla flavor
Questions Or Comments?
call toll-free 1-888-235-2466
Principal Display Panel
*** Compare to the active ingredients in Imodium ® Multi-Symptom Relief
NDC 69452-210-04
Loperamide HCl
and Simethicone Tablets,
2 mg/125 mg
Antidiarrheal/Anti-gas
Multi-Symptom Relief
Caplet
Relieves symptoms of diarrhea plus
- Cramps & Pressure
- Bloating
- Gas
Actual Size
6 Caplets*
*Capsule-shaped Tablets
* Please review the disclaimer below.