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

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Anti-Diarrheal

WOONSOCKET PRESCRIPTION CENTER,INCORPORATED

CVS 44-375


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Loperamide HCl 2 mg

Anti-diarrheal

controls symptoms of diarrhea, including Travelers’ Diarrhea

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

Do not use

if you have bloody or black stool.

Ask a doctor before use if you have

  • a 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 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 (1-800-222-1222) right away.

  • 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; 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
  • store between 20°-25°C (68°-77°F)

  • do not use if carton or blister unit is open or torn

  • 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

CVS®
pharmacy

Compare to the active ingredient in Imodium® A-D†
EASY OPEN

ANTI-DIARRHEAL
LOPERAMIDE HYDROCHLORIDE TABLETS, 2 mg
CONTROLS THE SYMPTOMS OF DIARRHEA

NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

24 CAPLETS*
*Each caplet (capsule-shaped tablets) contains 2 mg loperamide hydrochloride

Easy to swallow

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Imodium® A-D.
50844    REV1212D37508

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2013 CVS/pharmacy
www.cvs.com    1-800-shop-CVS

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

Anti-Diarrheal
CVS 44-375

Anti-Diarrheal

Loperamides TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-375
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
D&C YELLOW NO. 10
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
FD&C BLUE NO. 1
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 6 in 1 BLISTER PACK
2 6 in 1 BLISTER PACK
3 6 in 1 BLISTER PACK
4 6 in 1 BLISTER PACK
5 200 in 1 BOTTLE
6 96 in 1 BOTTLE
7 NDC:59779-375-46 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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