Tuesday, October 4, 2016

Anti-Diarrheal Tablet




Generic Name: loperamide hydrochloride

Dosage Form: tablet
Anti-Diarrheal

DRUG FACTS



Active ingredient


(in each caplet)

Loperamide HCl 2 mg



Purpose


Anti-diarrheal



Use


controls symptoms of diarrhea, including Travelers' Diarrhea



Warnings



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 then 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

  • 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

Other Information


  • store between 20°-25°C (68°-77°F)

  • 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



PRODUCT PACKAGING


The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.


Quality Plus


Anti-Diarrheal


Loperamide HCl Tablets USP, 2 mg


96 Caplets**


**Each caplet (capsule shaped tablet) Contains 2 mg of Loperamide Hydrochloride


TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING


Manufactured by LNK INTERNATIONAL, INC.


60 Arkay Drive, Hauppauge, NY 11788










ANTI-DIARRHEAL  
loperamide hcl  tablet










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)50844-375
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loperamide Hydrochloride (Loperamide)Loperamide Hydrochloride2 mg














Inactive Ingredients
Ingredient NameStrength
Starch, Corn 
D&c Yellow No. 10 
Magnesium Stearate 
Cellulose, Microcrystalline 
Silicon Dioxide 


















Product Characteristics
ColorGREEN (light)Score2 pieces
ShapeCAPSULE (Tablet)Size7mm
FlavorImprint Code44;375
Contains      










































Packaging
#NDCPackage DescriptionMultilevel Packaging
150844-375-456 TABLET In 1 BLISTER PACKNone
250844-375-0212 TABLET In 1 BLISTER PACKNone
350844-375-0824 TABLET In 1 BLISTER PACKNone
450844-375-221 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
448 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50844-375-22)
550844-375-231 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
572 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50844-375-23)
650844-375-461 BOTTLE In 1 CARTONcontains a BOTTLE, PLASTIC
696 TABLET In 1 BOTTLE, PLASTICThis package is contained within the CARTON (50844-375-46)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07649705/03/2005


Labeler - L.N.K. International, Inc. (038154464)

Registrant - L.N.K. International, Inc. (832867837)









Establishment
NameAddressID/FEIOperations
L.N.K. International, Inc832867894MANUFACTURE
Revised: 07/2010L.N.K. International, Inc.




More Anti-Diarrheal Tablet resources


  • Anti-Diarrheal Tablet Side Effects (in more detail)
  • Anti-Diarrheal Tablet Dosage
  • Anti-Diarrheal Tablet Use in Pregnancy & Breastfeeding
  • Drug Images
  • Anti-Diarrheal Tablet Drug Interactions
  • Anti-Diarrheal Tablet Support Group
  • 8 Reviews for Anti-Diarrheal - Add your own review/rating


Compare Anti-Diarrheal Tablet with other medications


  • Diarrhea
  • Diarrhea, Acute
  • Diarrhea, Chronic
  • Lymphocytic Colitis
  • Traveler's Diarrhea

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