Benztropine Mesylate

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• BENZTROPINE MESYLATE DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS & USAGE
• BENZTROPINE MESYLATE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• DRUG INTERACTIONS
• PEDIATRIC USE
• BENZTROPINE MESYLATE ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• INACTIVE INGREDIENT
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

BENZTROPINE MESYLATE DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS & USAGE

BENZTROPINE MESYLATE CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

DRUG INTERACTIONS

PEDIATRIC USE

BENZTROPINE MESYLATE ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

HOW SUPPLIED

*1965, Nov. 25, 1968.

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811
8182010
R3/08-R1

INACTIVE INGREDIENT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Benztropine Mesylate Benztropine Mesylate TABLET Product Information Product Type Human prescription drug label Item Code (Source) NDC:49349-700(NDC:0603-2435-32) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZTROPINE MESYLATE BENZTROPINE 2 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE lactose monohydrate MAGNESIUM STEARATE cellulose, microcrystalline Product Characteristics Color Size Imprint Code Shape white 7 mm 2327;V ROUND Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49349-700-02 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040715 2011-04-06