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Asacol

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ASACOL DESCRIPTION


Asacol





CLINICAL PHARMACOLOGY






PHARMACOKINETICS





CLINICAL STUDIES









INDICATIONS & USAGE



ASACOL CONTRAINDICATIONS



PRECAUTIONS









INFORMATION FOR PATIENTS




DRUG INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



PREGNANCY



NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE


PRECAUTIONS

ASACOL ADVERSE REACTIONS


Table 1


Asacol
Table 1











Renal subsection in PRECAUTIONS


DRUG ABUSE AND DEPENDENCE





OVERDOSAGE




DOSAGE & ADMINISTRATION






FERRIC OXIDE RED
FERRIC OXIDE YELLOW
LACTOSE MONOHYDRATE
MAGNESIUM STEARATEmethacrylic acid - methyl methacrylate copolymer (1:2)
POLYETHYLENE GLYCOL
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Asacol



Asacol

Asacol TABLET, DELAYED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-678(NDC:0149-0752)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MESALAMINE MESALAMINE 400 mg

Inactive Ingredients

Ingredient Name Strength
ferric oxide red
FERRIC OXIDE YELLOW
lactose monohydrate
MAGNESIUM STEARATE
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)
polyethylene glycol
povidone
SODIUM STARCH GLYCOLATE TYPE A POTATO
talc

Product Characteristics

Color Size Imprint Code Shape
red 1 mm Asacol;NE OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-678-23 180 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019651 2011-03-09


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Be sure to consult your doctor before taking any medication!
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