LOPERAMIDE HYDROCHLORIDE tablet

Loperamide Hydrochloride by

Drug Labeling and Warnings

Loperamide Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Loperamide hydrochloride USP 2 mg

Purpose

Anti-diarrheal

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide hydrochloride

Heart alert: Taking more than directed can cause serious heart problems or death

Do not use

if you have bloody or black stool

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. 

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 (1-800-222-1222) right away.

Directions

• drink plenty of clear fluids to help prevent dehydration caused by diarrhea
• find right dose on chart. If possible, use weight to dose; otherwise, use age.

    

• adults and children 12 years and over:

  2 tablets after the first loose stool; 1 tablet after each subsequent loose stool; but no more than 4 tablets in 24 hours;

• children 9 to 11 years (60 to 95 lbs):

  1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 3 tablets in 24 hours;

• children 6 to 8 years (48 to 59 lbs):

  1 tablet after the first loose stool; 1/2 tablet after each subsequent loose stool; but no more than 2 tablets 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

• store at 20° to 25°C (68° to 77°F).
• do not use if carton or blister unit is open or torn
• Meets USP dissolution test 2
• See side panel for lot number and expiration date

Inactive ingredients

colloidal silicon dioxide, D & C yellow No. 10 aluminum lake, FD & C blue No. 1, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate

Questions or comments?

call 1-855-274-4122

Distributed by:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Made in India

Code .: TS/DRUGS/22/2009

Relabeled By: Preferred Pharmaceuticals Inc.

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Blister Carton (4 x 6's Tablets)

AUROHEALTH
Relabeled By: Preferred Pharmaceuticals Inc.
NDC: 68788-8393
*Compare to the active
ingredient of Imodium® A-D

Loperamide Hydrochloride
Tablets USP 2 mg

Anti-Diarrheal

Controls the symptoms of diarrhea

24 Tablets

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-8393(NDC:58602-701)
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

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	GREEN (Light Green)	Score	2 pieces
Shape	CAPSULE (Biconvex)	Size	10mm
Flavor		Imprint Code	L;28
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-8393-2	4 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	ANDA206548	03/01/2023

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-8393)