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V-HIST Suspension

Generic Name: brompheniramine maleate and phenylephrine hydrochloride
Dosage Form: oral suspension

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

V-HIST® Suspension

Rx only

V-HIST Suspension Description

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

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

Phenylephrine HCl 10 mg
Brompheniramine Maleate 6 mg

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.

V-HIST Suspension - Clinical Pharmacology

V-HIST Suspension combines the sympathomimetic decongestant effect of Phenylephrine with the antihistaminic action of brompheniramine.

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.

Indications and Usage for V-HIST Suspension

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

Contraindications

V-HIST 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-HIST 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.

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.

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 anti and the overall effects of sympathomimetic agents. Patients may develop hyperpyrexia, hypotension, nausea myoclonic leg jerks, and coma following co-administration of MAO.

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

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY

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

PREGNANCY

Teratogenic Effects

Pregnancy Category C

Animal reproduction studies have not been conducted with V-HIST Suspension. It is also not known whether V-HIST Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. V-HIST 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-HIST Suspension should not be administered to a nursing mother.

Phenylketonurics: Contains Phenylalanine 5.863 mg per 5 mL.

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 and sympathomimetics 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.

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-HIST Suspension Dosage and Administration

V-HIST 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-HIST Suspension contains:
6 mg Brompheniramine Maleate and 10 mg Phenylephrine HCl.

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

How is V-HIST Suspension Supplied

V-HIST Suspension: (Phenylephrine HCl 10 mg and Brompheniramine Maleate 6 mg per 5 mL) is available in a Bubble Gum-flavored suspension in 4 fl. oz. bottles NDC No.: 44183-512-04.

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

541-63314-0

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

Antihistamine • Decongestant

NDC 44183-512-04

V-HIST
Suspension

Each Teaspoonful (5 mL) Contains:
Brompheniramine Maleate 6 mg
Phenylephrine HCl 10 mg

Shake Well
4 fl oz (118 mL)

Rx Only

V-HIST 
brompheniramine maleate and phenylephrine hydrochloride suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44183-512
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE 6 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME  
ASPARTAME  
CITRIC ACID MONOHYDRATE  
FD&C RED NO. 40  
GLYCERIN  
METHYLPARABEN  
MAGNESIUM ALUMINOMETASILICATE TYPE I-A  
WATER  
SODIUM BENZOATE  
SODIUM CITRATE  
XANTHAN GUM  
TANNIC ACID  
Product Characteristics
Color RED (LIGHT RED) Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:44183-512-04 118 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 02/04/2010
Labeler - Macoven Pharmaceuticals (832591965)
Revised: 12/2010
 
Macoven Pharmaceuticals

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