LOPERAMIDE HCL AND SIMETHICONE tablet

Loperamide HCl and Simethicone by

Drug Labeling and Warnings

Loperamide HCl and Simethicone by is a Otc medication manufactured, distributed, or labeled by Ohm Laboratories Inc., Sun Pharmaceutical Industries, Inc., Sun Pharmaceutical Industries Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

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

• Cramps & Pressure
• Bloating
• Gas

6 CAPLETS*
(*capsule-shaped tablets)

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

• Cramps & Pressure
• Bloating
• Gas

12 CAPLETS*
(*capsule-shaped tablets)

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

• Cramps & Pressure
• Bloating
• Gas

18 CAPLETS*
(*capsule-shaped tablets)

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

• Cramps & Pressure
• Bloating
• Gas

24 CAPLETS*
(*capsule-shaped tablets)

INGREDIENTS AND APPEARANCE

LOPERAMIDE HCL AND SIMETHICONE 
loperamide hcl and simethicone tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51660-069
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
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
Color	WHITE (white to off-white)	Score	no score
Shape	CAPSULE	Size	16mm
Flavor		Imprint Code	NA
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51660-069-06	6 in 1 BLISTER PACK; Type 0: Not a Combination Product	01/13/2022
2	NDC: 51660-069-12	2 in 1 CARTON	01/13/2022
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 51660-069-18	3 in 1 CARTON	01/13/2022
3		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 51660-069-24	4 in 1 CARTON	01/13/2022
4		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	ANDA077500	01/13/2022

Labeler - Ohm Laboratories Inc. (184769029)

Registrant - Sun Pharmaceutical Industries, Inc. (146974886)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharmaceutical Industries Limited		650456002	MANUFACTURE(51660-069)