V-COF

Macoven Pharmaceuticals

V-COF Suspension

FULL PRESCRIBING INFORMATION: CONTENTS*

• V-COF DESCRIPTION
• CLINICAL PHARMACOLOGY
  • PHENYLEPHRINE
  • BROMPHENIRAMINE
  • CARBETAPENTANE
• V-COF INDICATIONS AND USAGE
• V-COF CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • GENERAL
  • INFORMATION FOR PATIENTS
  • DRUG INTERACTIONS
  • CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
  • PREGNANCY
  • LABOR AND DELIVERY
  • NURSING MOTHERS
• V-COF ADVERSE REACTIONS
• OVERDOSAGE
  • SIGNS AND SYMPTOMS
  • TREATMENT
• V-COF DOSAGE AND ADMINISTRATION
  • CHILDREN
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

FULL PRESCRIBING INFORMATION

Rx Only

V-COF DESCRIPTION

V-COF Suspension is an antihistamine/nasal decongestant/antitussive combination for oral administration as a suspension.

Each 5 mL (one teaspoonful) of the Bubble Gum-flavored suspension for oral administration contains:

Inactive ingredients: Acesulfame, Artificial Bubble Gum, Aspartame, Citric Acid, FD&C Red #40, Glycerin, Methylparaben, Magnesium Aluminometasilicate, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Xanthan Gum and Galloquinate.

See Dosage and Administration section for further descriptive composition.

CLINICAL PHARMACOLOGY

V-COF Suspension combines the sympathomimetic decongestant effect of Phenylephrine with the antihistaminic action of brompheniramine and the antitussive effect of Carbetapentane.

PHENYLEPHRINE

Phenylephrine is a decongestant which is a potent postsynaptic α-receptor antagonist with little effect on β receptors of the heart. A direct action at receptors accounts for the greater part of its effects, only a small part being due to its ability to release norepinephrine. Phenylephrine has no effect on β-adrenergic receptors of the bronchi or peripheral blood vessels. Phenylephrine has a mild central stimulant effect.

BROMPHENIRAMINE

Brompheniramine is an antihistamine, H₁ receptor- blocking agent belonging to the alkylamine class of antihistamines. This group of antihistamines are among the most active histamine antagonists and are generally effective in relatively low doses.

These drugs are not so prone to produce drowsiness and are among the most suitable agents for daytime use; but again, a significant proportion of patients do experience this effect.

CARBETAPENTANE

Carbetapentane is a centrally acting non-narcotic antitussive agent. Carbetapentane has atropine-like and local anesthetic actions as well as temporarily controls and suppresses the cough reflex by selective depression of the medullary cough center. It is one and a half times that of codeine in depressing the cough reflex. It has no significant analgesic or sedative properties and does not depress respiration or predispose to addiction with usual doses. In therapeutic dosage Carbetapentane does not inhibit ciliary activity.

V-COF INDICATIONS AND USAGE

V-COF Suspension is indicated for the symptomatic relief of coryza, nasal congestion, and cough associated with the common cold, sinusitis, allergic rhinitis, and other upper respiratory tract conditions. Appropriate therapy should be provided for the primary disease.

V-COF CONTRAINDICATIONS

V-COF Suspension is contraindicated in patients sensitive to any of the ingredients or related compounds. Antihistamines are contraindicated for use in the treatment of lower respiratory tract symptoms, including asthma. Phenylephrine is contraindicated in patients with hypertension or with peripheral vascular insufficiency (ischemia may result with risk of gangrene or thrombosis of compromised vascular beds).

V-COF Suspension should not be used in patients receiving a monoamine oxidase inhibitor (MAOI) (see "PRECAUTIONS DRUG INTERACTIONS").

WARNINGS

This product contains an antihistamine that may cause drowsiness and may have additive central nervous system (CNS) effects with alcohol or other CNS depressants (e.g., hypnotics, sedatives, tranquilizers). Antihistamines should be used with caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, and urinary bladder obstruction due to symptomatic prostatic hypertrophy and narrowing of the bladder neck. Administration of Carbetapentane may be accompanied by histamine release and should be used with caution in atopic children.

PRECAUTIONS

GENERAL

Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients, and therefore should be used with caution. Antihistamines may cause excitation, particularly in pediatric patients, but their combination with sympathomimetics may cause either mild stimulation or mild sedation. Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, or narrow angle glaucoma.

Carbetapentane should be used with caution in sedated patients, and in patients confined to the supine position.

INFORMATION FOR PATIENTS

Caution patients against drinking alcoholic beverages or engaging in potentially hazardous activities requiring alertness, such as driving a car or operating machinery, while using this product. Patients should be warned not to use this product if they are now taking a prescription monoamine oxidase (MAO) inhibitor (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAO inhibitor drug. If patients are uncertain whether a prescription drug contains an MAO inhibitor, they should be instructed to consult a health professional before taking this product.

DRUG INTERACTIONS

MAO inhibitors may prolong and intensify the anticholinergic effects of antihistamines and the overall effects of sympathomimetic agents. Patients may develop hyperpyrexia, hypotension, nausea, myoclonic leg jerks, and coma following co-administration of MAO inhibitors and Carbetapentane.

Thus, concomitant administration of V-COF Suspension and MAO inhibitors should be avoided (see "CONTRAINDICATIONS").

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

No long-term animal studies have been performed with V-COF Suspension.

PREGNANCY

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with V-COF Suspension. It is also not known whether V-COF Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. V-COF Suspension should be given to a pregnant woman only if clearly needed.

LABOR AND DELIVERY

Administration of Phenylephrine to patients in late pregnancy or labor may cause fetal anoxia or bradycardia by increasing contractility of the uterus and decreasing uterine blood flow.

NURSING MOTHERS

Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, V-COF Suspension should not be administered to a nursing mother.

Phenylketonurics: Contains Phenylalanine 8.419 mg per 5 mL.

V-COF ADVERSE REACTIONS

The most common effects associated with antihistamines have been drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines, sympathomimetics, and antitussives have been rare. Other adverse reactions may include:

Dermatologic - urticaria, drug rash, photosensitivity, pruritus.

Cardiovascular - hypotension, hypertension, cardiac arrhythmias, palpitations.

Central Nervous System (CNS) - disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsion, headache, euphoria, and dysphoria.

Genitourinary – urinary frequency, difficult urination.

Gastrointestinal – epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.

Respiratory – tightness of chest and wheezing, shortness of breath.

Hematologic – hemolytic anemia, thrombocytopenia, agranulocytosis.

OVERDOSAGE

SIGNS AND SYMPTOMS

May vary from CNS depression to stimulation (restlessness to convulsions). Antihistamine overdosage in young children may lead to convulsions and death. Atropine-like signs and symptoms may be prominent. Carbetapentane may produce central excitement and mental confusion.

TREATMENT

Induce vomiting if it has not occurred spontaneously. Precautions must be taken against aspiration especially in infants, children, and comatose patients. If gastric lavage is indicated, isotonic or half-isotonic saline solution is preferred. Stimulants should not be used. If hypotension is a problem, vasopressor agents may be considered.

V-COF DOSAGE AND ADMINISTRATION

V-COF Suspension: Administer the recommended dose up to four times daily.

CHILDREN

Over 12 years of age - 5 to 10 mL (1 to 2 teaspoonfuls);
6 to 12 years of age - 5 mL (1 teaspoonful);
2 to 6 years of age - 2.5 mL (1/2 teaspoonful);
Under 2 years of age - Consult a physician.

Each 5 mL of V-COF Suspension contains:
6 mg Brompheniramine Maleate, 10 mg Phenylephrine HCl and 25 mg Carbetapentane Citrate in a suspension.

Note: The Hydrochloride salt of Phenylephrine, the Maleate salt of Brompheniramine, and the Citrate salt of Carbetapentane are provided by means of a patented manufacturing process.

HOW SUPPLIED

V-COF Suspension: (Phenylephrine HCl 10 mg, Brompheniramine Maleate 6 mg, and Carbetapentane Citrate 25 mg per 5 mL) is available in a Bubble Gum-flavored suspension in 4 fl. oz. bottles NDC No.: 44183- 514-04.

Store at controlled room temperature, 20°-25°C (68°-77°F).

Dispense in a tight, light resistant container (USP/NF) with a child-resistant closure.

Patent protected.

Rx Only

Manufactured for:
Macoven Pharmaceuticals
Magnolia, TX 77354

Rev. 12/09
541-64314-0

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Antihistamine • Decongestant • Antitussive

NDC 44183-514-04

V-COF
Suspension

Shake Well
4 fl oz (118 mL)

Rx Only