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 IMO-GEN LABS LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT(S)

(in each tablet)
Loperamide Hydrochloride USP 2 mg
Simethicone USP 125 mg

PURPOSES

Anti-diarrheal
Anti-gas

USE(S)

relieves symptoms of diarrhea plus bloating, pressure and cramps, commonly referred to as gas

WARNINGS

Allergry alert: Do not user if you have ever had a rash or other allergic reaction to loperamide hydrochloride

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 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 get abdominal swelling or bulging. These may be signs of a serious condition.
you have difficulty swallowing the tablet

If pregnant or breast-feeding, ask a health professional before use.

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 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours
• children 9-11 years (60-95 lbs):

  1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours

• children 6-8 years (48-59 lbs): 1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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 tablet contains: calcium 640 mg, very low sodium and potassium 5.838 mg
store between 20 to 25°C (68 to 77°F). Protect from light.
do not use if carton is open or if blister unit is open or torn

INACTIVE INGREDIENTS

acesulfame potassium, croscarmellose sodium, dibasic calcium phosphate, microcrystalline cellulose, stearic acid and vanilla flavor

PRINCIPAL DISPLAY PANEL

Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 
loperamide hydrochloride and simethicone tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84441-713
Route of Administration	ORAL

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

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

Product Characteristics
Color	white	Score	2 pieces
Shape	CAPSULE	Size	17mm
Flavor	VANILLA	Imprint Code	H;L21
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84441-713-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	10/23/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211438	10/23/2025

Labeler - IMO-GEN LABS LLC (119282683)