LOPERAMIDE HCL AND SIMETHICONE- loperamide hcl and simethicone tablet 
Ohm Laboratories Inc.

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Drug Facts

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 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 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 (1800-222-1222).

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; 1/2 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; 1/2 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 (upto 33 lbs)

do not use

Other information

•
calcium: contains 142 mg/caplet
•
store between 20-25° C (68-77° F). Protect from light.
•
TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

Inactive ingredients

calcium silicate, colloidal silicon dioxide, dibasic calcium phosphate, microcrystalline cellulose, sodium starch glycolate, stearic acid

Questions?

call 1-800-406-7984

Manufactured by:
Sun Pharmaceutical
Industries Limited,
MOHALI, INDIA

Distributed by:
Ohm Laboratories Inc.,
New Brunswick,
NJ 08901

PRINCIPAL DISPLAY PANEL - 6 Capsule Blister Pack Carton

†Compare To
the active ingredients of
Imodium®
Multi-Symptom Relief

NDC 51660-069-06

ohm®

Loperamide HCl and
Simethicone Tablets,
2 mg/125 mg

Anti-Diarrheal/Anti-Gas
Multi-Symptom Relief

Relieves symptoms of diarrhea plus

6 CAPLETS*
(*capsule-shaped tablets)

PRINCIPAL DISPLAY PANEL - 6 Capsule Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 12 Caplet Blister Pack Carton

†Compare To
the active ingredients of
Imodium®
Multi-Symptom Relief

NDC 51660-069-12

ohm®

Loperamide HCl and
Simethicone Tablets,
2 mg/125 mg

Anti-Diarrheal/Anti-Gas
Multi-Symptom Relief

Relieves symptoms of diarrhea plus

12 CAPLETS*
(*capsule-shaped tablets)

PRINCIPAL DISPLAY PANEL - 12 Caplet Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 18 Caplet Blister Pack Carton

†Compare To
the active ingredients of
Imodium®
Multi-Symptom Relief

NDC 51660-069-18

ohm®

Loperamide HCl and
Simethicone Tablets,
2 mg/125 mg

Anti-Diarrheal/Anti-Gas
Multi-Symptom Relief

Relieves symptoms of diarrhea plus

18 CAPLETS*
(*capsule-shaped tablets)

PRINCIPAL DISPLAY PANEL - 18 Caplet Blister Pack Carton

PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

†Compare To
the active ingredients of
Imodium®
Multi-Symptom Relief

NDC 51660-069-24

ohm®

Loperamide HCl and
Simethicone Tablets,
2 mg/125 mg

Anti-Diarrheal/Anti-Gas
Multi-Symptom Relief

Relieves symptoms of diarrhea plus

24 CAPLETS*
(*capsule-shaped tablets)

PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton
LOPERAMIDE HCL AND SIMETHICONE 
loperamide hcl and simethicone tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51660-069
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
CALCIUM SILICATE (UNII: S4255P4G5M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
Product Characteristics
ColorWHITE (white to off-white) Scoreno score
ShapeCAPSULESize16mm
FlavorImprint Code NA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51660-069-066 in 1 BLISTER PACK; Type 0: Not a Combination Product01/13/2022
2NDC:51660-069-122 in 1 CARTON01/13/2022
26 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:51660-069-183 in 1 CARTON01/13/2022
36 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:51660-069-244 in 1 CARTON01/13/2022
46 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07750001/13/2022
Labeler - Ohm Laboratories Inc. (184769029)
Registrant - Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Sun Pharmaceutical Industries Limited650456002MANUFACTURE(51660-069)

Revised: 8/2022
Document Id: 86ddd92a-920c-40b8-b0bd-29bfb3b38bfc
Set id: 06f99f59-e702-49f1-bb1d-e7cf58c54c30
Version: 3
Effective Time: 20220830
 
Ohm Laboratories Inc.