LOPERAMIDE HYDROCHLORIDE tablet

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

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
AmerisourceBergen
1 West First Avenue
Conshohocken, PA 19428
Questions or Concerns?

www.mygnp.com

Made in India

Code : TS/DRUGS/22/2009
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 2 mg Blister Carton 12(2 x 6's Tablets)

GOOD                                          *Compare to Imodium® A-D
NEIGHBOR                                   active ingredient
PHARMACY®                                NDC: 46122-738-53

Loperamide Hydrochloride
Tablets USP 2 mg

Anti-Diarrheal

Controls the symptoms of diarrhea

12 Tablets                    actual size

INGREDIENTS AND APPEARANCE

LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LOPERAMIDE HYDROCHLORIDE (UNII: 77TI35393C) (LOPERAMIDE - UNII:6X9OC3H4II)	LOPERAMIDE HYDROCHLORIDE	2 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 46122-738-53	2 in 1 CARTON	07/05/2023
1		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 46122-738-62	4 in 1 CARTON	07/20/2023
2		6 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206548	07/05/2023

Labeler - Amerisource Bergen (007914906)

Registrant - Aurohealth LLC (078728447)

Name	Address	ID/FEI	Business Operations
Establishment
Aurobindo Pharma Limited		650381903	ANALYSIS(46122-738) , MANUFACTURE(46122-738)

Loperamide Hydrochloride by