1 INDICATIONS AND USAGE Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

Nitroglycerin is a nitrate vasodilator indicated for relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

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6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail elsewhere in the label: Hypotension [see Warnings and Precautions (5.2) ] Headache [see Warnings and Precautions (5.4) ] Hypersensitivity [see Contraindications (4.4) ] Vertigo, dizziness, weakness, palpitation, and other manifestations of postural hypotension may develop occasionally, particularly in erect, immobile patients.

Marked sensitivity to the hypotensive effects of nitrates (manifested by nausea, vomiting, weakness, diaphoresis, pallor, and collapse) may occur at therapeutic doses.

Syncope due to nitrate vasodilatation has been reported.

Flushing, drug rash, and exfoliative dermatitis have been reported in patients receiving nitrate therapy.

Most common adverse reactions occurring at a frequency greater than 2% are headache, dizziness and paresthesia.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc.

at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .