LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE tablet

Loperamide Hydrochloride and Simethicone by

Drug Labeling and Warnings

Loperamide Hydrochloride and Simethicone by is a Otc medication manufactured, distributed, or labeled by Granules India Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each caplet)

Loperamide HCl, 2 mg

Simethicone, 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. (1-800-222-1222)

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 ag

• 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 148.40 mg, sodium 1.40 mg
• store between 20-25°C (68-77°F). Protect from light.
• for blister: do not use if blister unit is torn or broken

Inactive Ingredients

acesulfame potassium, anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, flavor, microcrystalline cellulose, stearic acid.

Questions or comments?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Manufactured by:

Granules India Limited

Hyderabad-500 081, INDIA

MADE IN INDIA

PRINCIPAL DISPLAY PANEL

Loperamide Hydrochloride and Simethicone Tablets 2 mg/125 mg


ANTI-DIARRHEAL / ANTI-GAS

Multi-Symptom Relief Caplet

Relieves symptoms of diarrhea plus

• Cramps & Pressure
• Bloating
• Gas

12 Caplets *

*capsule-shaped tablets

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 
loperamide hydrochloride and simethicone tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-739
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
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
STEARIC ACID (UNII: 4ELV7Z65AP)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white (off white)	Score	2 pieces
Shape	CAPSULE (Capsule shaped tablet)	Size	17mm
Flavor	VANILLA	Imprint Code	I;9
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-739-69	2 in 1 CARTON	03/01/2023
1		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	ANDA215981	03/01/2023

Labeler - Granules India Ltd (915000087)