248 - Health A2z Anti-diarrheal

248 - Health A2z Anti-diarrheal
SPL v5
SPL
SPL Set ID aca3742c-2a82-4e91-8aaf-2fce08487e56
Route
ORAL
Published
Effective Date 2017-11-13
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

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

■ store at 20º-25ºC (68º-77º F)   ■ avoid excessive heat above 40ºC (104ºF)

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
 Health A2Z®

*Compare to the active ingredient in IMODIUM® A-D

Anti-Diarrheal

Loperamide HCl 2mg

Controls the symptoms of diarrhea

(pill image)

12 CAPLETS

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 (1-800-222-1222) right away.

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

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)

■ store at 20º-25ºC (68º-77º F)   ■ avoid excessive heat above 40ºC (104ºF)

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
 Health A2Z®

*Compare to the active ingredient in IMODIUM® A-D

Anti-Diarrheal

Loperamide HCl 2mg

Controls the symptoms of diarrhea

(pill image)

12 CAPLETS

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 (1-800-222-1222) right away.

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)