Anti-Diarrheal Tablet

Pronunciation

Generic Name: loperamide hydrochloride
Dosage Form: tablet

Anti-Diarrheal

DRUG FACTS

Active ingredient

(in each caplet)
Loperamide HCl 2 mg

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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 Type HUMAN OTC DRUG 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) Loperamide Hydrochloride 2 mg
Inactive Ingredients
Ingredient Name Strength
Starch, Corn  
D&c Yellow No. 10  
Magnesium Stearate  
Cellulose, Microcrystalline  
Silicon Dioxide  
Product Characteristics
Color GREEN (light) Score 2 pieces
Shape CAPSULE (Tablet) Size 7mm
Flavor Imprint Code 44;375
Contains         
Packaging
# Item Code Package Description
1 NDC:50844-375-45 6 TABLET (TABLET) in 1 BLISTER PACK
2 NDC:50844-375-02 12 TABLET (TABLET) in 1 BLISTER PACK
3 NDC:50844-375-08 24 TABLET (TABLET) in 1 BLISTER PACK
4 NDC:50844-375-22 1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
4 48 TABLET (TABLET) in 1 BOTTLE, PLASTIC
5 NDC:50844-375-23 1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
5 72 TABLET (TABLET) in 1 BOTTLE, PLASTIC
6 NDC:50844-375-46 1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON
6 96 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076497 05/03/2005
Labeler - L.N.K. International, Inc. (038154464)
Registrant - L.N.K. International, Inc. (832867837)
Establishment
Name Address ID/FEI Operations
L.N.K. International, Inc 832867894 MANUFACTURE
Revised: 07/2010
 
L.N.K. International, Inc.



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