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
Purpose

Anti-diarrheal

Description

Loperamide HCl 2mg

Medication Information

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.

Purpose

Anti-diarrheal

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
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

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

Description

Loperamide HCl 2mg

Principal Display Panel

Anti Diarrheal


Use(s)

controls symptoms of diarrhea, including Travelers’ Diarrhea

Questions

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

Do Not Use
  • if you have bloody or black stool
Active Ingredient(s)

Loperamide HCl 2mg

Pregnancy/breastfeeding

ask a health professional before use.

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

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.

Purpose

Anti-diarrheal

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
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

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

Principal Display Panel

Anti Diarrheal


Use(s)

controls symptoms of diarrhea, including Travelers’ Diarrhea

Questions

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

Do Not Use (Do not use)
  • if you have bloody or black stool
Active Ingredient(s) (Active ingredient(s))

Loperamide HCl 2mg

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

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

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

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