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Asacol

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ASACOL DESCRIPTION


Asacol



CLINICAL PHARMACOLOGY




PHARMACOKINETICS





CLINICAL STUDIES

Mildly to moderately active ulcerative colitis:AsacolAsacolAsacolAsacol
AsacolAsacol

Maintenance of remission of ulcerative colitis:AsacolAsacolAsacol
AsacolAsacol

Study to assess the effect on male fertility:AsacolAsacol

INDICATIONS & USAGE

Asacol

ASACOL CONTRAINDICATIONS

AsacolAsacol

PRECAUTIONS

General:Asacol
AsacolAsacolAsacol
Asacol

Renal:AsacolAsacolAsacolAsacol

Asacol

INFORMATION FOR PATIENTS

Asacol
Asacol

DRUG INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Asacol

PREGNANCY

Teratogenic Effects:

NURSING MOTHERS



PEDIATRIC USE

Asacol

GERIATRIC USE

AsacolAsacol.Asacol
PRECAUTIONSAsacolAsacol

ASACOL ADVERSE REACTIONS

AsacolAsacol
AsacolAsacolAsacol
AsacolTable 1Asacol

Table 1 Frequency (%) of Common Adverse Events Reported in Ulcerative Colitis Patients Treated with Asacol Tablets or Placebo in Short-Term (6-Week) Double-Blind Controlled Studies
Asacol
AsacolAsacol
AsacolTable 1Asacol-


Body as a Whole:
Cardiovascular:
Gastrointestinal:
Hematologic:
Musculoskeletal:
Nervous:
Respiratory/Pulmonary:
Skin:
Special Senses:
Urogenital:Renal subsection in PRECAUTIONS
Laboratory Abnormalities:

DRUG ABUSE AND DEPENDENCE





OVERDOSAGE

AsacolAsacolAsacol

DOSAGE & ADMINISTRATION

For the treatment of mildly to moderately active ulcerative colitis:

For the maintenance of remission of ulcerative colitis:


HOW SUPPLIED





STORAGE AND HANDLING



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Asacol

Asacol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL













Asacol

MESALAMINE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-494(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
brown 1 mm Asacol;NE OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-494-02 30 in 1 BLISTER PACK
2 NDC:49349-494-23 180 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019651 2011-08-17


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Be sure to consult your doctor before taking any medication!
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