Anti-Diarrheal description, usages, side effects, indications, overdosage, supplying and lots more!

Anti-Diarrheal

Western Family Foods, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Loperamide HCl 2 mg softgel

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient (in each capsule)

Loperamide HCI 2 mg

Purpose

Anti- diarrheal

Use

controls symptoms of diarrhea, including Traveler's Diarrhea

Warnings

Allergy alert: Do not use if you have ever had a rash or other allergic reaction to loperamide HCl

Do not use

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

When using this product

tiredness, drowsiness, or dizziness may occur. Be careful when driving or operating machinery.

Stop use and ask 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.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • drink plenty of clear fluids to help prevent dehydration caused by diarrhea
  • not for use in children under 12 years of age
  • adults and children 12 years of age and over: 2 softgels after the first loose stool; 1 softgel after each subsequent loose stool; but no more than 4 softgels in 24 hours

Other information

  • do not use if carton or blister unit is open or torn
  • store at 20o-25o C (68o-77o F)
  • avoid excessive heat above 40°C (104°F).
  • see side panel for lot number and expiration date
  • use the 1 mg soft gelatin capsule product for children 6 to under 12 years of age

Inactive Ingredients

Questions or comments?

1-800-447-1140

Principal Display Panel

COMPARE TO ACTIVE INGREDIENT OF IMODIUM® A-D **

A-D

Anti-Diarrheal

Soft Gelatin Capsules, 2mg

Loperamide HCl

Controls the symptoms of diarrhea

Suitable for adults and children 12 years and over

24 SOFTGELS*

*each liquid-capsule contains 2 mg Loperamide HCl

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

**This product is not manufactured or distributed by McNeil Consumer and Specialty Pharmaceuticals, owner of the registered trademark of Imodium® A-D.


Proudly distributed by

Western family foods, Inc

PO Box 4057, Portland, OR 97208 USA

www.westernfamily.com

Product Label

Product Label
Loperamide HCl 2 mg

Anti-Diarrheal

LOPERAMIDE HYDROCHLORIDE CAPSULE, LIQUID FILLED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55312-520(NDC:10888-7098)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LOPERAMIDE HYDROCHLORIDE LOPERAMIDE 2 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
FD&C BLUE NO. 1
GELATIN
GLYCERIN
GLYCERYL CAPRYLATE
POLYOXYL 40 HYDROGENATED CASTOR OIL
water

Product Characteristics

Color Size Imprint Code Shape
BLUE 19 mm P13 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:55312-520-24 2 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021855 2010-07-05


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