Crantex

ACTIVE INGREDIENTS: Each 5 mL (teaspoonful) contains:

Phenylephrine Hydrochloride .......................... 7.5 mg
Guaifenesin ....................................................... 100 mg

INACTIVE INGREDIENTS: Citric Acid, Orange Flavoring, Sorbitol Solution, Propylene Glycol, Purified Water, Saccharin Sodium, Sodium Benzoate, and Sodium Chloride.

Phenylephrine hydrochloride

Benzenemethanol,3-hydroxy-α-[(methylamino) methyl]-hydrochloride (R)-., is an adrenergic, which occurs as white or practically white, odorless crystals having a bitter taste. It is freely soluble in water and alcohol.

Guaifenesin

1,2-Propanediol, 3-(2-methoxyphenoxy)-, (±)-., is a white to slightly gray, crystalline powder, having a bitter taste. It may have a slight characteristic odor. It is soluble in water, alcohol, chloroform, glycerin, and propylene glycol.

Crantex Liquid® is contraindicated in infants and newborns, and in patients with a known hypersensitivity to any of the components. It is also contraindicated in patients with severe hypertension, severe coronary artery disease, hyperthyroidism, and in patients on MAO inhibitor therapy (or for 14 days after stopping MAOI therapy). Patient idiosyncrasy to adrenergic agents may be manifested by insomnia, dizziness, weakness, tremor, or arrhythmias.

Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a doctor. If symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor.

Mild central nervous system stimulation, especially in those patients who are hypersensitive to sympathomimetic drugs, may occur. Hyperreactive individuals may display ephedrine-like reactions such as tachycardia, palpitations, headache, dizziness, or nausea. Nervousness, excitability, restlessness, weakness, and insomnia may also occur. Headache and drowsiness have also been reported. Large doses may cause light-headedness, nausea and/or vomiting. Sympathomimetic drugs have also been associated with certain untoward reactions including fear, anxiety, tenseness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucination, convulsion, CNS depression, arrhythmias and cardiovascular collapse with hypotension.

Crantex Liquid® is clear, orange flavored and supplied in bottles of 16 fl. oz. (473 mL) NDC 51991-233-16.

Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487

Manufactured by:
Tri-Med Laboratories, Inc.,
Somerset, NJ 08873

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

REV. 4/08

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.