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

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Anti-Diarrheal

L.N.K. International, Inc.

Quality Plus 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

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

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

Quality Plus

NDC 50844-375-02

*Compare to the active ingredients in Extra Strength Imodium® A-D

Anti-Diarrheal
Loperamide HCl 2 mg

Controls the symptoms of diarrhea

12 Caplets

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength ImoDium® A-D.

50844        REV1212B37502

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788

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

Anti-Diarrheal
Quality Plus 44-375

Anti-Diarrheal

Loperamide HCl TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50844-375
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
STARCH, CORN
D&C YELLOW NO. 10
MAGNESIUM STEARATE
cellulose, microcrystalline
SILICON DIOXIDE

Product Characteristics

Color Size Imprint Code Shape
GREEN (light) 7 mm 44;375 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 6 in 1 BLISTER PACK
2 6 in 1 BLISTER PACK
3 48 in 1 BOTTLE, PLASTIC
4 72 in 1 BOTTLE, PLASTIC
5 96 in 1 BOTTLE, PLASTIC
6 NDC:50844-375-46 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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