Quartuss Syrup

Generic Name: dextromethorphan hydrobromide, chlorpheniramine maleate, phenylephrine hydrochloride, and guaifenesin
Dosage Form: oral syrup

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Quartuss™ Syrup
Cough Suppressant/Antihistamine/Nasal Decongestant/Expectorant
Alcohol Free • Sugar Free

Quartuss Syrup Description

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

Dextromethorphan Hydrobromide, USP 15 mg
Chlorpheniramine Maleate, USP 2 mg
Phenylephrine Hydrochloride, USP 10 mg
Guaifenesin, USP 100 mg

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)-,(±)-.

Quartuss Syrup - Clinical Pharmacology

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.

INDICATIONS

Cough suppressant, antihistamine, nasal decongestant, and expectorant as an aid in the management of cough and mucosal congestion or edema of the respiratory tract, or nasal passages due to the common cold, bronchitis, laryngitis, tracheitis, pharyngitis, pertussis, influenza, measles, or chronic paranasal sinusitis.

Contraindications

Hypersensitivity to any of the ingredients. Also contraindicated in patients with hypertension, hyperthyroidism, prostatic hypertrophy, and patients on MAO inhibitor therapy (or for 14 days after stopping MAOI therapy).

Warnings

Use with caution in the presence of cardiac disorders, diabetes or peripheral vascular disease.

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.

Stimulants, such as phenylephrine, are banned and tested for by the U.S. Olympic Committee (USOC) and the National Collegiate Athletic Association (NCAA).

Precautions

Pregnancy

Category C

It is not known whether Quartuss™ Syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, Quartuss™ Syrup should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Quartuss™ Syrup is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in the pediatric population, under 6, have not been established.

Adverse Reactions

May include drowsiness, dizziness, nervousness, insomnia, headache, palpitation, dysuria.

Note: Guaifenesin has been shown to produce a color interference with certain clinical laboratory determinations of 5-hydroxyindoleacetic acid (5-HIAA) and vanillylmandelic acid (VMA).

Overdosage

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 Dosage and Administration

Adults and Children 12 years of age or older: Two teaspoonfuls. Children 6 to 12 years of age: One teaspoonful. Dose may be repeated every 6 hours. Do not exceed four doses in a 24-hour period. This product is not indicated for use in children under 6 years of age. (see PRECAUTIONS, Pediatric Use.)

How Supplied

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

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:

Dextromethorphan Hydrobromide, USP 15 mg
Chlorpheniramine Maleate, USP 2 mg
Phenylephrine Hydrochloride, USP 10 mg
Guaifenesin, USP 100 mg

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

QUARTUSS 
dextromethorphan hydrobromide, chlorpheniramine maleate, phenylephrine hydrochloride, and guaifenesin syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51991-513
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide 15 mg  in 5 mL
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 2 mg  in 5 mL
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg  in 5 mL
Guaifenesin (Guaifenesin) Guaifenesin 100 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Benzoate  
Citric Acid Monohydrate  
Saccharin Sodium  
Propylene Glycol  
Sorbitol  
Sucralose  
Glycerin  
D&C Red No. 33  
Water  
Product Characteristics
Color PINK (Dark Pink) Score     
Shape Size
Flavor CHERRY Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:51991-513-16 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 05/01/2007 11/30/2011
Labeler - Breckenridge Pharmaceutical, Inc. (150554335)
Establishment
Name Address ID/FEI Operations
Trimed 182050567 MANUFACTURE
Revised: 11/2010
 
Breckenridge Pharmaceutical, Inc.

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