LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE- loperamide hydrochloride and simethicone tablet 
Granules India Ltd

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Loperamide Hydrochloride and Simethicone Tablets, 2 mg/125 mg

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

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 a 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 over2 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, 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

12 Caplets *

*capsule-shaped tablets

foil

carton

LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 
loperamide hydrochloride and simethicone tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-739
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
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
Colorwhite (off white) Score2 pieces
ShapeCAPSULE (Capsule shaped tablet) Size17mm
FlavorVANILLAImprint Code I;9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-739-692 in 1 CARTON03/01/2023
16 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21598103/01/2023
Labeler - Granules India Ltd (915000087)

Revised: 1/2023
Document Id: f33adff8-806e-2a38-e053-2a95a90a5532
Set id: e0c1693e-0e55-4368-a8a5-2f0882fbf952
Version: 2
Effective Time: 20230127
 
Granules India Ltd