Loperamide Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Loperamide Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

LOPERAMIDE HYDROCHLORIDE DESCRIPTION



Loperamide Hydrochloride




CLINICAL PHARMACOLOGY



INDICATIONS & USAGE


LOPERAMIDE HYDROCHLORIDE CONTRAINDICATIONS









WARNINGS






PRECAUTIONS

General

INFORMATION FOR PATIENTS


ADVERSE REACTIONS.)

DRUG INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY




PREGNANCY








NURSING MOTHERS


PEDIATRIC USE

WARNINGSsection for information on the greater variability of response in this age group.

LOPERAMIDE HYDROCHLORIDE ADVERSE REACTIONS

Clinical Trial Data













*
*
Postmarketing Experience









CONTRAINDICATIONSandWARNINGS).










DRUG ABUSE AND DEPENDENCE

Abuse


Dependence

OVERDOSAGE






DOSAGE & ADMINISTRATION




Acute Diarrhea













Chronic Diarrhea















PRECAUTIONS).


PRECAUTIONS).

HOW SUPPLIED



STORAGE AND HANDLING




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Loperamide Hydrochloride


Loperamide Hydrochloride


Loperamide Hydrochloride

LOPERAMIDE HYDROCHLORIDE CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:24236-083(NDC:0093-0311)
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
MAGNESIUM STEARATE
DIMETHICONE
GELATIN
FERROSOFERRIC OXIDE
ferric oxide red
FERRIC OXIDE YELLOW
lactose monohydrate
STARCH, CORN
SHELLAC
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
brown 14 mm TEVA;0311 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:24236-083-08 10 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA073192 2012-08-21


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