LOPERAMIDE HYDROCHLORIDE, SIMETHICONE tablet

Loperamide Hydrochloride, Simethicone by

Drug Labeling and Warnings

Loperamide Hydrochloride, Simethicone by is a Otc medication manufactured, distributed, or labeled by Guardian Drug Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS (in each caplet)

Loperamide HCl 2 mg

Simethicone 125 mg

PURPOSE

Anti-diarrheal

Anti-gas

USE(S)

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 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 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 9-11 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 180 mg, sodium 3 mg
• store between 20-25°C (68-77°F). Protect from light
• do not use if blister unit is torn or broken.

INACTIVE INGREDIENTS

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, flavor, microcrystalline cellulose, stearic acid

QUESTIONS OR COMMENTS?

call 1-609-860-2600 (Monday - Friday 8 am - 4 pm)

PRINCIPAL DISPLAY PANEL

NDC: 53041-263-50

Multi-Symptom Relief Caplet

Loperamide Hydrochloride and Simethicone

Tablets, 2 mg/125 mg

Anti-diarrheal/Anti-gas

Relieves symptoms of diarrhea plus

Cramps & Pressure

Bloating

Gas

6 Caplets**

**capsule-shaped tablets

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE, SIMETHICONE 
loperamide hydrochloride, simethicone tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53041-263
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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	2 pieces
Shape	CAPSULE	Size	16mm
Flavor	CARAMEL (caramel vanilla)	Imprint Code	2;63
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53041-263-50	1 in 1 CARTON	06/01/2021
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	ANDA214541	06/01/2021

Labeler - Guardian Drug Company (119210276)

Establishment
Name	Address	ID/FEI	Business Operations
Guardian Drug Company		119210276	MANUFACTURE(53041-263)