248 - Anti Diarrheal

248 - Anti Diarrheal
SPL v2
SPL
SPL Set ID 3ec4c6c7-c297-4ae4-b275-4c015e922bec
Route
ORAL
Published
Effective Date 2022-01-06
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 Magnesium Stearate Fd&c Blue No. 1 Aluminum Lake Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 44;375 Shape: capsule Color: green Size: 10 mm Score: 2
Marketing Status
ANDA Active Since 2022-03-01
Description

Loperamide HCl 2mg

Purpose

Anti-diarrheal

Medication Information

Purpose

Anti-diarrheal

Description

Loperamide HCl 2mg

Use(s)

controls symptoms of diarrhea, including Travelers’ Diarrhea

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reactions to loperamide HCl.

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

Questions

Call 1-800-824-1706 Monday - Friday 9AM - 4PM MST

Directions
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • find right dose below. 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; ½ 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; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
  • children 2-5 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
Other Information

store at 20º-25ºC (68º-77º F)

avoid excessive heat above 40ºC (104ºF)

do not use if blister unit is broken or torn

Active Ingredient(s)

Loperamide HCl 2mg

Inactive Ingredients

corn starch, D&C yellow #10

aluminum lake, dicalcium phosphate dihydrate, FD&C

blue #1 brilliant blue lake, magnesium stearate,

microcrystalline cellulose, silica gel

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

Anti Diarrheal


When Using This Product

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

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

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 Or Pharmacist Before Use If

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



Structured Label Content

Use(s)

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 reactions to loperamide HCl.

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

Questions

Call 1-800-824-1706 Monday - Friday 9AM - 4PM MST

Directions
  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • find right dose below. 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; ½ 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; ½ caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
  • children 2-5 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
Other Information (Other information)

store at 20º-25ºC (68º-77º F)

avoid excessive heat above 40ºC (104ºF)

do not use if blister unit is broken or torn

Active Ingredient(s) (Active ingredient(s))

Loperamide HCl 2mg

Inactive Ingredients (Inactive ingredients)

corn starch, D&C yellow #10

aluminum lake, dicalcium phosphate dihydrate, FD&C

blue #1 brilliant blue lake, magnesium stearate,

microcrystalline cellulose, silica gel

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel

Anti Diarrheal


When Using This Product (When using this product)

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

Ask A Doctor Before Use If (Ask a doctor before use if)
  • fever  
  • mucus in the stool  
  • a history of liver disease
  • a history of abnormal heart rhythm
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.

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 Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

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



Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:07.892192 · Updated: 2026-03-14T23:00:28.895348