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

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

Storage

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



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.







Questions

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

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

■ 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

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

Use(s)

controls symptoms of diarrhea, including Travelers’ Diarrhea

Purpose

Anti-Diarrheal

Storage

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



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.







Questions

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

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)

■ 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)

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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