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

Purpose

Anti-diarrheal

Description

Loperamide HCl 2 mg


Medication Information

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.

Purpose

Anti-diarrheal

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

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

Description

Loperamide HCl 2 mg

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.

Questions?

call toll-free 1-866-933-6337

Use

Controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5

Distributed by:

IBS LABS

Wilmington, DE 19801

Do Not Use:
  • if you have bloody or black stool.
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

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.

Purpose

Anti-diarrheal

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

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.

Questions?

call toll-free 1-866-933-6337

Use

Controls symptoms of diarrhea, including Travelers' Diarrhea

Section 42229-5 (42229-5)

Distributed by:

IBS LABS

Wilmington, DE 19801

Do Not Use: (Do not use:)
  • if you have bloody or black stool.
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)