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

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Anti-Diarrheal

GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.

Healthcare 44-375


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each caplet)

Loperamide HCl 2 mg

Purpose

Antidiarrheal

Use

controls symptoms of diarrhea, including Travelers' Diarrhea

Warnings

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

Do not use

 if you have bloody or black stool

Ask a doctor before use if you have

  •  high 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 a doctor if

  • symptoms get worse
  • diarrhea lasts for more than 2 days
  • you get abdominal swelling or buldging. 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
  • find right dose on chat. If possible, use weight to dose; otherwise, use age.
adults and children 12 years and older  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 first loose stool; 1/2 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; 1/2 caplet after each subsequent loose stool; but no more than 2 caplets in 24 hours
children under 6 years (up to 47 lbs) ask a doctor

Anti-Diarrheal Other information

  • store at controlled room temperature 20º-25ºC (68º-77ºF)
  • see end flap for expiration date and lot number
  • do not use if carton or blister unit is open 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

Questions or comments?

Call 1-800-426-9391 8:30 AM-4:00 PM ET, Monday-Friday

Principal Display Panel

HEALTHCARE
NDC 64092-105-12

Anti-Diarrheal
Loperamide Hydrochloride Caplets, 2 mg

Controls the Symptoms of Diarrhea

Compare to the active ingredient in Imodium® A-D Caplets*

12 CAPLETS

* This product is not manufactured or distributed by Schering-Plough HealthCare Products, owner of the registered trademark Correctol®.
50844    REV1212G37502

Distributed by:
Great Lakes Wholesale & Marketing L.L.C.
3729 Patterson Ave., S.E.
Grand Rapids, MI 49512
www.glwholesale.com

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

Anti-Diarrheal

Healthcare 44-375

Anti-Diarrheal

Loperamide HCl CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64092-105
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
MAGNESIUM STEARATE
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
GREEN 10 mm 44;375 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 12 in 1 BLISTER PACK
2 NDC:64092-105-12 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076497 2005-05-03


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Be sure to consult your doctor before taking any medication!
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