Bion Loperamide Simethicone Tablets
SPL UNCLASSIFIED SECTION
Drug Facts
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
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking a prescription drug. Loperamide may interact with certain prescription drugs.
OTC - WHEN USING SECTION
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 SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
| 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 |
- 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.
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
SPL UNCLASSIFIED SECTION
***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