Anti-diarrheal

Anti-diarrheal
SPL v2
SPL
SPL Set ID 1b5f2c7c-baf0-b213-e063-6394a90a25df
Route
ORAL
Published
Effective Date 2024-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loperamide (2 mg)
Inactive Ingredients
Starch, Corn D&c Yellow No. 10 Aluminum Lake Dibasic Calcium Phosphate Dihydrate Fd&c Blue No. 1 Aluminum Lake Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;375 Shape: oval Color: green Size: 10 mm Score: 2
Marketing Status
ANDA Active Since 2024-01-01

Description

Loperamide HCl 2 mg

Purpose

Anti-diarrheal


Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCl 2 mg

Use

Controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5

Distributed by:

IBS LABS

Wilmington, DE 19801

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.

Directions
  • drink plenty of clear liquid 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 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; 1/2 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; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children 2-5 years (34-47 lbs) ask a doctor
children under 2 years (up to 33 lbs) do not use

Questions?

call toll-free 1-866-933-6337

Do Not Use:
  • if you have bloody or black stool.
Other Information
  • store between  20° and 25°C (68° and 77°F)
Inactive Ingredients

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue#1 brilliant blue, magnesium stearate, microcrystalline cellulose, silica gel

Principal Display Panel

Compare to the active ingredient in Imodium ®A-D

Anti-Diarrheal

Loperamide Hydrocholoride Caplets, 2 mg

Controls Symptoms of Diarrhea

This product is not manufactured or distributed by the owner of the registered trademark Imodium ®A-D.

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 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.

Active Ingredient (in Each Caplet)

Loperamide HCl 2 mg

Ask A Doctor Before Use If You Are

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

Ask A Doctor Before Use If You Have:
  • fever
  • mucus in the stool
  • a history of liver disease
  • a history of abnormal heart rhythm

Structured Label Content

Use

Controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5 (42229-5)

Distributed by:

IBS LABS

Wilmington, DE 19801

Purpose

Anti-diarrheal

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.

Directions
  • drink plenty of clear liquid 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 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; 1/2 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; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children 2-5 years (34-47 lbs) ask a doctor
children under 2 years (up to 33 lbs) do not use

Questions?

call toll-free 1-866-933-6337

Do Not Use: (Do not use:)
  • if you have bloody or black stool.
Other Information (Other information)
  • store between  20° and 25°C (68° and 77°F)
Inactive Ingredients (Inactive ingredients)

corn starch, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate, FD&C blue#1 brilliant blue, magnesium stearate, microcrystalline cellulose, silica gel

Principal Display Panel

Compare to the active ingredient in Imodium ®A-D

Anti-Diarrheal

Loperamide Hydrocholoride Caplets, 2 mg

Controls Symptoms of Diarrhea

This product is not manufactured or distributed by the owner of the registered trademark Imodium ®A-D.

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 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.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Loperamide HCl 2 mg

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

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

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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)