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Loperamide Hydrochloride by Proficient Rx LP

Medically reviewed on Feb 1, 2018

Dosage form: tablet
Ingredients: LOPERAMIDE HYDROCHLORIDE 2mg
Labeler: Proficient Rx LP
NDC Code: 63187-462

Drug Facts

ACTIVE INGREDIENT (IN EACH CAPLET)

Loperamide HCl USP, 2 mg

PURPOSE

Anti-diarrheal

USE(S)

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 HCI

Do not use

if you have bloody or black stool

Ask a doctor before use if you have
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
diarrhea lasts for more than 2 days
symptoms get worse
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 (1-800-222-1222).

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;
½ 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;
½ 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 side panel for lot number and expiration date
TAMPER EVIDENT: THIS PRODUCT PROTECTED WITH SEALED BLISTER UNITS. DO NOT USE IF ANY ARE TORN OR BROKEN.

INACTIVE INGREDIENTS

anhydrous lactose, croscarmellose sodium, crospovidone, D&C yellow no.10, FD&C blue no.1, hydrogenated vegetable oil, magnesium stearate, powdered cellulose, pregelatinized starch

QUESTIONS?

call 1800-406-7984

Keep the carton. It contains important information.

Distributed by:

Ohm Laboratories Inc.

1385 Livingston Avenue

North Brunswick, NJ 08902

Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

ohm®

NDC 51660-123-12

Loperamide HCl Tablets, USP 2 mg

Anti-Diarrheal

12 CAPLETS

Each caplet(capsule-shaped tablet) contains Loperamide HCl, USP 2 mg

Controls The Symptoms of Diarrhea

*Compare to the active ingredient of Imodium® A-D

*This product is not manufactured or distributed by McNeil-PPC, distributor of Imodium® A-D.

Imodium®is a registered trademark of Johnson & Johnson.

LOPERAMIDE HYDROCHLORIDE 
loperamide hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-462(NDC:51660-123)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LOPERAMIDE HYDROCHLORIDE (LOPERAMIDE) LOPERAMIDE HYDROCHLORIDE2 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
CROSPOVIDONE (15 MPA.S AT 5%) 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
POWDERED CELLULOSE 
STARCH, CORN 
GLYCERYL TRISTEARATE 
ANHYDROUS LACTOSE 
Product Characteristics
ColorgreenScore2 pieces
ShapeCAPSULESize9mm
FlavorImprint Code123
Contains    
Packaging
#Item CodePackage Description
1NDC:63187-462-1212 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07409102/01/1993
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574RELABEL(63187-462)

 
Proficient Rx LP

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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