LOPERAMIDE HYDROCHLORIDE, SIMETHICONE - loperamide hydrochloride, simethicone tablet 
Guardian Drug Company

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Loperamide and Simethicone Caplets

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

ASK A DOCTOR BEFORE USE IF YOU HAVE

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

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



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

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



79

LOPERAMIDE HYDROCHLORIDE, SIMETHICONE 
loperamide hydrochloride, simethicone tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53041-263
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II) LOPERAMIDE HYDROCHLORIDE2 mg
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE125 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore2 pieces
ShapeCAPSULESize16mm
FlavorCARAMEL (caramel vanilla) Imprint Code 2;63
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53041-263-501 in 1 CARTON06/01/2021
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21454106/01/2021
Labeler - Guardian Drug Company (119210276)
Establishment
NameAddressID/FEIBusiness Operations
Guardian Drug Company119210276MANUFACTURE(53041-263)

Revised: 6/2021
Document Id: 289e6064-8eb8-4b56-bc9e-ee82ad83674f
Set id: 1b79204e-8a99-455b-84d6-f381fd7d1135
Version: 2
Effective Time: 20210601
 
Guardian Drug Company