Sudatex DM

Each immediate-release tablet for oral administration contains:

Pseudoephedrine HCl ……..…. 40 mg

Guaifenesin ……………………... 400 mg

Dextromethorphan HBr …..…. 20 mg

Pseudoephedrine hydrochloride is an adrenergic (vasoconstrictor) which occurs as fine, white to off white crystals or powder, having a faint characteristic odor. It is very soluble in water, freely soluble in alcohol and sparingly soluble in chloroform. The chemical name is benzenemethanol, (-[1-(methylamino) ethyl]-, [S-(R*,R*)]-, hydrochloride. The structural formula is:

C10H15NO • HCl                        M.W. 201.70

Guaifenesin is an expectorant and occurs as a white to slightly gray, crystalline powder, having a bitter taste. It may have a slight characteristic odor. It is soluble in water, in alcohol, in chloroform, in glycerin and in propylene glycol. Chemically, Guaifenesin is 1,2-Propanediol, 3-(2-methoxyphenoxy)-,(+) and has the following structural formula:

C10H14O4                                       M.W. 198.22

Dextromethorphan Hydrobromide is an antitussive with the chemical name 3-Methoxy-17-methyl-9(, 13(, 14(-morphinan. Its structure is as follows:

C18H25NO • HBr • H2O             M.W. 370.32

Croscarmellose Sodium, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Polyvinylpyrrolidone, Silica and Stearic Acid.

SUDATEX - DM is contraindicated in patients with hypersensitivity to Guaifenesin, Dextromethorphan Hydrobromide, or with hypersensitivity or idiosyncrasy to sympathomimetic amines which may be manifested by insomnia, dizziness, weakness, tremor or arrhythmias. Sympathomimetic amines are contraindicated in patients with severe hypertension, severe coronary artery disease and in patients on monoamine oxidase (MAO) inhibitor therapy.

Nursing Mothers: Contraindicated because of the higher than usual risk for infants from sympathomimetic amines.

Geriatric patients may be more sensitive to the effects of this medication.

Newborn or Premature Infants: SUDATEX - DM Tablets should not be administered to premature or full-term infants.

Sympathomimetic amines should be used judiciously and sparingly in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, or prostatic hypertrophy. Sympathomimetics may produce CNS stimulation and convulsions or cardiovascular collapse with accompanying hypotension.
Do not exceed recommended dosage.

Hypertensive crises can occur with concurrent use of Pseudoephedrine and an MAO inhibitor, and for 14 days after stopping the MAO inhibitor therapy, indomethacin, or with beta blockers and methyldopa. If a hypertensive crisis occurs, these drugs should be discontinued immediately and therapy to lower blood pressure should be instituted. Fever should be managed by means of external cooling.

Hyper-reactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea. Sympathomimetics have been associated with certain untoward reactions including fear, anxiety, nervousness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, CNS depression, arrhythmias, and cardiovascular collapse with hypotension. No serious side effects have been reported with the use of Guaifenesin or Dextromethorphan.

SUDATEX - DM Tablets are supplied as a white, capsule- shaped tablet, debossed “LL 242”; in bottles of 100 tablets. NDC 68047-242-01

Storage and Handling

Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

Protect from light and moisture. Store at room temperature, USP

WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Rx Only

Report Adverse Reactions to:

Distributed by:

276 Nissan Parkway, Suite B
Canton, MS 39046

Or Call Toll Free: 1-888-527-5522

Manufactured by:

Contract Pharmacal Corp.
135 Adams Ave.
Hauppauge, NY 11788 USA

Rev. 09/08