Label: LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE tablet
- NDC Code(s): 69452-210-04, 69452-210-12
- Packager: Bionpharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 19, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (in each caplet)
- Purposes
- Uses
-
Warnings
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.
-
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 hourschildren 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 hourschildren 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 hourschildren 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
- Inactive ingredients
-
Questions or comments?
call toll-free 1-888-235-2466
***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
-
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 mgAntidiarrheal/Anti-gas
Multi-Symptom Relief
Caplet
Relieves symptoms of diarrhea plus
- Cramps & Pressure
- Bloating
- Gas
Actual Size
6 Caplets*
*Capsule-shaped Tablets
-
INGREDIENTS AND APPEARANCE
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
loperamide hydrochloride and simethicone tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69452-210 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE 2 mg DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 125 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) VANILLA (UNII: Q74T35078H) Product Characteristics Color white (off-white) Score 2 pieces Shape CAPSULE Size 17mm Flavor Imprint Code LS1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69452-210-04 1 in 1 CARTON 12/19/2021 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:69452-210-12 4 in 1 CARTON 12/19/2021 2 6 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA213484 12/01/2021 Labeler - Bionpharma Inc. (079637826) Registrant - Bionpharma Inc. (079637826) Establishment Name Address ID/FEI Business Operations Recipharm Pharmaservices Pvt. Ltd. 871401927 manufacture(69452-210)