Quartuss Syrup

Quartuss™ Syrup is a cough suppressant, antihistamine, nasal decongestant syrup available for oral administration. Each teaspoonful (5mL.) contains:

INACTIVE INGREDIENTS

Sodium Benzoate, Citric Acid, Saccharin Sodium, Propylene Glycol, Sorbitol Solution, Glycerin, Sucralose, Cherry Flavor, D&C Red No. 33, Purified Water.

Phenylephrine Hydrochloride

C9H13NO2HCl    M.W. 203.67

Benzenemethanol, 3-hydroxy-α-[(methylamino)methyl]-, hydrochloride (R)-.

Chlorpheniramine Maleate

C16H19ClN2 • C4H4O4    M.W. 390.86

2-Pyridinepropanamine, γ-(4-chlorophenyl)-N, N-dimethyl-, (Z)-2-butenedioate (1:1)

Dextromethorphan Hydrobromide

C18H25NO • HBr • H2O    M.W. 370.32

Morphinan, 3-Methoxy-17-methyl-, (9α, 13α, 14α)-, hydrobromide, monohydrate.

Guaifenesin

C10H14O4    M.W. 198.22

1,2-Propanediol, 3-(2-methoxyphenoxy)-,(±)-.

Dextromethorphan hydrobromide acts centrally to elevate the threshold for coughing. It has no analgesic or addictive properties. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration.

Chlorpheniramine maleate competitively antagonizes most of the smooth muscle stimulation actions of histamine on the H1 receptors of the GI tract, uterus, large blood vessels and bronchial muscle. It also antagonizes the action of histamine that results in increased capillary permeability and the formation of edema.

Phenylephrine hydrochloride acts predominantly by a direct action on alpha adrenergic receptors. In therapeutic doses, the drug has no significant stimulant effect on the beta adrenergic receptors of the heart. Following oral administration, constriction of blood vessels in the nasal mucosa may relieve nasal congestion. In therapeutic doses, the drug causes little, if any, central nervous system stimulation.

Guaifenesin promotes lower respiratory tract drainage by thinning bronchial secretions, lubricates irritated respiratory tract membranes through increased mucus flow, and facilitates removal of viscous, inspissated mucus. As a result, sinus and bronchial drainage is improved, and dry, nonproductive coughs become more productive and less frequent.

Signs and Symptoms

Overdosage with Dextromethorphan HBr may produce CNS excitement and mental confusion.

Overdosage with sympathomimetic amines can cause hypertension, headache, convulsions, cerebral hemorrhage and vomiting. Premature ventricular beats and short paroxysms of ventricular tachycardia may also occur. Headache may be a symptom of hypertension. Bradycardia may also be seen early in phenylephrine HCl overdosage through stimulation of baroreceptors. Excessive CNS stimulation may result in excitement, tremor, restlessness, and insomnia. Other effects may include pallor, mydriasis, hyperglycemia, and urinary retention. Severe overdosage may cause tachypnea, or hypernea, hallucinations, convulsions, or delirium, but in some individuals, there may be CNS depression. Arrhythmias (including ventricular fibrillation) may lead to hypotension and circulatory collapse. Severe hypokalemia can occur, probably due to compartmental shift rather than depletion of potassium.

Should antihistamine effects predominate, central action constitutes the greatest danger. In the small child, symptoms include excitation, hallucination, ataxia, incoordination, tremors, flushed face and fever. Convulsions, fixed and dilated pupils, coma and death may occur in severe cases. In the adult, fever and flushing are uncommon; excitement leading to convulsions and postictal depression is often preceded by drowsiness and coma. Respiration is usually not seriously depressed; blood pressure is usually stable.

Overdosage with Guaifenesin is unlikely to produce toxic effects since its toxicity is low. Guaifenesin, when administered by stomach tube to test animals in doses up to 5 gm/kg, produced no signs of toxicity.

Treatment

The patient should be induced to vomit (pharmacologic vomiting is the preferred method; by the administration of ipecac syrup), unless the patient is comatose, convulsing or has lost the gag reflex, in which case gastric lavage should be performed using a large bore tube. If indicated, follow with activated charcoal and a saline cathartic. Precautions must be taken against aspiration, especially in infants, children and comatose patients.

Quartuss™ Syrup is a cherry flavored, sugar free, alcohol free liquid supplied in 16 fl. oz. bottles, NDC 51991-513-16.

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

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from freezing.

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

Rx Only

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

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

ISS. 02/07
Rev. 4/08

Breckenridge
Pharmaceutical, Inc.

NDC 51991-513-16

Quartuss™
Syrup

Cough Suppressant/Antihistamine/
Nasal Decongestant/Expectorant

• Sugar Free
• Alcohol Free

Description: Each 5ml (one teaspoonful) for oral
administration contains:

INACTIVE INGREDIENTS: Sodium Benzoate,
Citric Acid, Saccharin Sodium, Propylene Glycol,
Sorbitol Solution, Glycerin, Sucralose, Cherry
Flavor, D&C Red No. 33, Purified Water.

Rx Only

Net Contents:
16 fl oz (One Pint) 473 mL