ANTI-DIARRHEAL/ANTI-GAS CAPLETS- loperamide hydrochloride 2mg, simethicone 125mg tablet

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 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 have difficulty swallowing the caplet
- you get abdominal swelling or bulging. These may be signs of a serious condition.
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 (1-800-222-1222) right away.

Directions

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; ½ 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; ½ 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 (up to 33 lbs)	do not use

Other information
- each caplet contains: calcium 155 mg, sodium 3 mg
- store at 20-25°C (68-77°F)
- protect from light
Inactive ingredients

acesulfame potassium, anhydrous dicalcium phosphate, colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, stearic acid, vanilla flavor
Questions?

call toll-free 1-866-933-6337
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INGREDIENTS AND APPEARANCE

ANTI-DIARRHEAL/ANTI-GAS CAPLETS
loperamide hydrochloride 2mg, simethicone 125mg tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	125 mg

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 73581-178-24	4 in 1 CARTON	07/24/2025
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA213484	09/10/2021

Labeler - YYBA CORP (006339772)

Registrant - YYBA CORP (006339772)

Name	Address	ID/FEI	Business Operations
Establishment
OrBion Pharmaceuticals Private Limited		854403569	manufacture(73581-178)

Anti-Diarrheal/Anti-Gas Caplets by