248-anti-diarrheal

248-anti-diarrheal
SPL v5
SPL
SPL Set ID ff8719b7-4283-4e2c-baf6-65f250f48938
Route
oral
Published
Effective Date 2020-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
loperamide (2 mg)
Inactive Ingredients
starch, corn magnesium stearate microcrystalline cellulose d&c yellow no. 10 aluminum lake fd&c blue no. 1

Identifiers & Packaging

Pill Appearance
Imprint: 44;375 Shape: capsule Color: green Size: 10 mm Score: 2
Marketing Status
anda active Since 2005-05-03

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 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 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

■ 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

Storage

■ store at room temperature 20º-25ºC (68º-77º F) 



Questions

Call 1-888-952-0050 Monday-Friday 9AM-5PM EST

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

you have ■ fever ■ mucus in the stool ■ a history of liver disease ■ a history of abnormal heart rhythm

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





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.


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 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)

■ 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

Storage

■ store at room temperature 20º-25ºC (68º-77º F) 



Questions

Call 1-888-952-0050 Monday-Friday 9AM-5PM EST

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)

you have ■ fever ■ mucus in the stool ■ a history of liver disease ■ a history of abnormal heart rhythm

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





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.


Advanced Ingredient Data


Raw Label Data

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