OTC Medication Information: Loperamide HCl and Simethicone

LOPERAMIDE HCL AND SIMETHICONE- loperamide hydrochloride and dimethicone tablet
Ohm Laboratories Inc.

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

Package/Label Principal Display Panel

NDC 51660-069-03

See New Warnings and Directions

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)

Keep the carton. It contains important information.

Manufactured by:

Sun Pharmaceutical Industries Limited,

MOHALI, INDIA

Distributed by:

Ohm Laboratories Inc.

New Brunswick, NJ 08901

0721

6 caplets carton
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE 2 mg
DIMETHICONE (DIMETHICONE) DIMETHICONE 125 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SILICATE
SILICON DIOXIDE
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MICROCRYSTALLINE CELLULOSE
STEARIC ACID
SODIUM STARCH GLYCOLATE TYPE A POTATO
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 Multilevel Packaging
1 NDC:51660-069-06 6 TABLET in 1 BLISTER PACK None
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 Operations
Sun Pharmaceutical Industries Limited 650456002 MANUFACTURE (51660-069)

Revised: 01/2022 Ohm Laboratories Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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