SPL v2
SPL
SPL Set ID 6c15f077-9f90-4262-9c17-a1ac70e45f57
Route
ORAL
Published
Effective Date 2024-03-29
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Loperamide (2 mg)
Inactive Ingredients
Silicon Dioxide D&c Yellow No. 10 Fd&c Blue No. 1 Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Pill Appearance
Imprint: L;28 Shape: capsule Color: green Size: 10 mm Score: 2
Marketing Status
ANDA Active Since 2023-07-05

Description

Active ingredient (in each tablet) Loperamide hydrochloride USP 2 mg

Purpose

Anti-diarrheal


Medication Information

Purpose

Anti-diarrheal

Description

Active ingredient (in each tablet) Loperamide hydrochloride USP 2 mg

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

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



Do Not Use

if you have bloody or black stool

Drug Facts

Active ingredient (in each tablet)



Loperamide hydrochloride USP 2 mg

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

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.

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.

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










Structured Label Content

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Purpose

Anti-diarrheal

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

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



Do Not Use (Do not use)

if you have bloody or black stool

Drug Facts

Active ingredient (in each tablet)



Loperamide hydrochloride USP 2 mg

Other Information (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 (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? (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

When Using This Product (When using this product)

tiredness, drowsiness or dizziness may occur. Be careful when driving or operating machinery.

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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.

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking a prescription drug. Loperamide may interact with certain prescription drugs.

Package Label Principal Display Panel 2 Mg Blister Carton 12(2 X 6's Tablets) (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










Advanced Ingredient Data


Raw Label Data

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