Organidin NR

ORGANIDIN® NR (guaifenesin)

Tablets — Each round, scored, rose-colored tablet contains 200 mg guaifenesin USP—available in bottles of 100 (NDC 0037-4312-01)

Storage

Store at controlled room temperature 20°-25°C (68°-77°F). Protect tablets from moisture. Keep bottle tightly closed.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120. Rev. 11/09

Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, drain bronchial tubes and make coughs more productive. Helps loosen phlegm and thin bronchial secretions in patients with stable chronic bronchitis.

ORGANIDIN® NR (guaifenesin)

Tablets — Adults and children 12 years of age and older: One to 2 tablets (200 mg to 400 mg) every four hours, not to exceed 2400 mg (12 tablets) in 24 hours.

PATIENTS SHOULD BE ADVISED TO KEEP THESE AND ALL DRUGS OUT OF THE REACH OF CHILDREN AND TO SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY IN CASE OF ACCIDENTAL OVERDOSE.

Hypersensitivity to any of the ingredients.

WARNINGS

No information provided.

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies to assess the long-term carcinogenic and mutagenic potential or the effect on fertility in animals or humans have not been performed.

Pregnancy

Teratogenic Effects - Pregnancy Category C

Animal reproduction studies have not been conducted. Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, these products should not be used in pregnant patients unless, in the judgment of the physician, the potential benefits outweigh possible hazards.

Nursing Mothers

It is not known whether guaifenesin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when these products are administered to a nursing woman and a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

SIDE EFFECTS

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch.

Guaifenesin is well tolerated and has a wide margin of safety. Side effects have been generally mild and infrequent. Nausea and vomiting are the side effects that occur most commonly. Dizziness, headache, and rash (including urticaria) have been reported rarely.

DRUG INTERACTIONS

Laboratory Test Interactions

Guaifenesin or its metabolites may cause color interference with the VMA (vanillylmandelic acid) test for catechols. It may also falsely elevate the level of urinary 5-HIAA (5-hydroxyindoleacetic acid) in certain serotonin metabolite chemical tests because of color interference.

Teratogenic Effects - Pregnancy Category C

Animal reproduction studies have not been conducted. Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Therefore, these products should not be used in pregnant patients unless, in the judgment of the physician, the potential benefits outweigh possible hazards.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800- FDA-1088 or www.fda.gov/medwatch.

Guaifenesin is well tolerated and has a wide margin of safety. Side effects have been generally mild and infrequent. Nausea and vomiting are the side effects that occur most commonly. Dizziness, headache, and rash (including urticaria) have been reported rarely.

In massive overdosage the stomach should be emptied (emesis and/or gastric lavage) and further absorption prevented. Treatment is symptomatic and supportive.

The acute toxicity of guaifenesin is low and overdosage is unlikely to produce serious toxic effects. In laboratory animals no toxicity resulted when guaifenesin was administered by stomach tube in doses up to 5 grams/kg.