LOPERAMIDE HYDROCHLORIDE, SIMETHICONE tablet

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)

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

LOPERAMIDE HYDROCHLORIDE, SIMETHICONE
loperamide hydrochloride, simethicone 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: 53041-263-50	1 in 1 CARTON	06/01/2021
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	ANDA214541	06/01/2021

Labeler - Guardian Drug Company (119210276)

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

Loperamide Hydrochloride, Simethicone by