248 - Health A2z Anti-diarrheal

248 - Health A2z Anti-diarrheal
SPL v2
SPL
SPL Set ID 952fa976-ac4c-4dfb-b689-12c5242498ac
Route
ORAL
Published
Effective Date 2019-09-19
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 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

 

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.

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Questions

1-800-327-2704

Directions
  • drink plenty of clear fluids 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; 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
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
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 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 right away (1-800-222-1222) .

If Pregnant Or Breast Feeding,

If pregnant or breast feeding, ask a health professional before use.

Active Ingredient (in Each Caplet)

Loperamide HCl 2mg

Ask A Doctor Before Use If You Have
  • fever  
  • mucus in the stool  
  • a history of liver disease
Ask A Doctor Or Pharmacist Before Use If You Are

taking antibiotics


Structured Label Content

 

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.

Use

controls symptoms of diarrhea, including Travelers’ Diarrhea

Purpose

Anti-diarrheal

Questions

1-800-327-2704

Directions
  • drink plenty of clear fluids 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; 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
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
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 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)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222) .

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

If pregnant or breast feeding, ask a health professional before use.

Active Ingredient (in Each Caplet) (Active Ingredient (in each caplet))

Loperamide HCl 2mg

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
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking antibiotics


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)