LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE tablet

Loperamide hydrochloride and Simethicone by

Drug Labeling and Warnings

Loperamide hydrochloride and Simethicone by is a Otc medication manufactured, distributed, or labeled by Bionpharma Inc., OrBion Pharmaceuticals Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Ask a doctor or pharmacist before use if you aretaking a prescription drug. Loperamide may interact with certain prescription drugs.

When using this producttiredness, 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 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

ⱡThis product is not manufactured or distributed by the owners of Imodium ®Multi-Symptom Relief

THIS PRODUCT IS PACKAGED IN A CHILD-RESISTANT AND TAMPEREVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Manufactured for:

BIONPHARMA

Princeton, NJ 08540

MADE IN INDIA

L0001183

R1025

Code: TN/Drugs/TN00002222/2006

949129361

PRINCIPAL DISPLAY PANEL

ⱡCompare to the active ingredients in Imodium ®Multi-Symptom Relief

anti-diarrheal/anti-gas

Loperamide HCl and simethicone tablets, 2 mg/125 mg

multi-symptom relief caplet

Relieves symptoms of diarrhea plus

• Cramps & Pressure
• Bloating
• Gas

24 Caplets*

*Capsule-shaped Tablets

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 
loperamide hydrochloride and simethicone tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69452-531
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	LII
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69452-531-12	4 in 1 CARTON	01/07/2026
1		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	01/07/2026

Labeler - Bionpharma Inc. (079637826)

Registrant - Bionpharma Inc. (079637826)

Establishment
Name	Address	ID/FEI	Business Operations
OrBion Pharmaceuticals Private Limited		854403569	manufacture(69452-531)