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 NORTHEAST PHARMA, Aurohealth LLC, APL HEALTHCARE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

(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 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 to 11 years (60 to 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 to 8 years (48 to 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 to 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 165 mg, sodium 4 mg
• store between 20° to 25°C (68° to 77°F). Protect from light.
• do not use if carton is opened or if individual blister units are torn or opened

Inactive ingredients

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

Questions or comments?

call 1-855-274-4122

(Monday – Friday 8:30 AM to 5:00 PM EST)

Dist. By: Northeast Pharma
South Burlington, VT 05403
1-800-383-0648

Made in India

Code: AP/DRUGS/04/2016

REV 1021

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg/125mg (24 Caplets) Blister Carton Label

Heartland™

Pharna Co.

NDC: 80136-384-24
LOPERAMIDE HCl and
SIMETHICONE TABLETS
2 mg/125 mg

LOPERAMIDE HCl 2 mg - ANTIDIARRHEAL / SIMETHICONE 125 mg - ANTI-GAS

Multi-Sympton Relief Caplet

Relieves symptoms of diarrhea plus

  Cramps & Pressure        Bloating      Gas   

Compare to the active ingridients of
IMODIUM®  MULTI-SYMPTON RELIEF**

T    79
Actual Size

24 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: 80136-384
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
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE (off-white)	Score	2 pieces
Shape	CAPSULE	Size	17mm
Flavor	VANILLA	Imprint Code	T;79
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80136-384-24	4 in 1 CARTON	10/27/2021
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	ANDA211059	10/27/2021

Labeler - NORTHEAST PHARMA (081232935)

Registrant - Aurohealth LLC (078728447)

Establishment
Name	Address	ID/FEI	Business Operations
APL HEALTHCARE LIMITED		650918514	ANALYSIS(80136-384) , MANUFACTURE(80136-384)