Antihistamine / Decongestant / Antitussive

NDC 66992-220-04

The Cough Suppressant for Working and Active People

VAZOTAN®Tannate SuspensionRx OnlyDESCRIPTIONVAZOTAN TANNATE SUSPENSIONSuspension is an antihistamine/nasaldecongestant/ antitussive combination for oraladministration as a suspension. Each 5 mL (oneteaspoonful) of the Bubble Gum-flavored,suspension for oral administration contains:Phenylephrine HCl. . . . . . . . . . . . . . 10 mgBrompheniramine Maleate. . . . . . . . . . . . 6 mgCarbetapentane Citrate. . . . . . . . . . . . . 25 mgInactive ingredients: Acesulfame, ArtificialBubble Gum, Aspartame, Citric acid, FD&C Red#40, glycerin, methylparaben, Neusilin, purifiedwater, sodium benzoate, sodium citratedihydrate, xanthan gum. See Dosage andAdministration section for further descriptivecomposition.

CLINICAL PHARMACOLOGYVAZOTAN TANNATE SUSPENSION combinesthe sympathomimetic decongestant effect ofPhenylephrine with the antihistaminic action ofbrompheniramine and the antitussive effect ofCarbetapentane.PHENYLEPHRINEPhenylephrine is a decongestant which is apotent postsynaptic _-receptor antagonist withlittle effect on _ receptors of the heart. A directaction at receptors accounts for the greater partof its effects, only a small part being due to itsability to release norepinephrine. Phenylephrinehas no effect on _-adrenergic receptors of thebronchi or peripheral blood vessels.Phenylephrine has a mild central stimulanteffect. BROMPHENIRAMINE:Brompheniramine is an antihistamine, H1receptor blocking agent belonging to thealkylamine class of antihistamines.This group of antihistamines are among themost active histamine antagonists and aregenerally effective in relatively low doses. These drugs are not so prone to producedrowsiness and are among the most suitableagents for daytime use; but again, a significantproportion of patients do experience this effect.CARBETAPENTANE: Carbetapentane is acentrally acting non-narcotic antitussive agent. Carbetapentane has atropine-like and localanesthetic actions as well as temporarilycontrols and suppresses the cough reflex byselective depression of the medullary coughcenter. It is one and a half times that of codeinein depressing the cough reflex. It has nosignificant analgesic or sedative properties anddoes not depress respiration or predispose toaddiction with usual doses. In therapeutic dosage Carbetapentane does not inhibit ciliaryactivity.

INDICATIONS AND USAGEVAZOTAN TANNATE SUSPENSION is indicatedfor the symptomatic relief of coryza, nasalcongestion, and cough associated with thecommon cold, sinusitis, allergic rhinitis, andother upper respiratory tract conditions.Appropriate therapy should be providedfor the primary disease.

CONTRAINDICATIONSVAZOTAN TANNATE SUSPENSION iscontraindicated in patients sensitive to any ofthe ingredients or related compounds.Antihistamines are contraindicatedfor use in the treatment of lower respiratory tractsymptoms, including asthma. Phenylephrine iscontraindicated in patients with hypertension orwith peripheral vascular insufficiency (ischemiamay result with risk of gangrene or thrombosisof compromised vascular beds).VAZOTAN TANNATE SUSPENSION should notbe used in patients receiving a monoamineoxidase inhibitor(MAOI) (see “PRECAUTIONSDRUG INTERACTIONS”).

WARNINGSThis product contains an antihistamine that maycause drowsiness and may have additive centralnervous system (CNS) effects with alcohol orother CNS depressants (e.g., hypnotics,sedatives, tranquilizers). Antihistamines shouldbe used with caution in patients with stenosingpeptic ulcer, pyloroduodenal obstruction, andurinary bladder obstruction due to symptomaticprostatic hypertrophy and narrowing of thebladder neck. Administration of Carbetapentanemay be accompanied by histamine release andshould be used with caution in atopic children.PRECAUTIONS GENERAL:Antihistamines are more likely to causedizziness, sedation, and hypotension in elderlypatients, and therefore should be used withcaution. Antihistamines may cause excitation,particularly in pediatric patients, but theircombination with sympathomimetics may causeeither mild stimulation or mild sedation. Usewith caution in patients with hypertension, cardiovascular disease, hyperthyroidism,diabetes, or narrow angle glaucoma. Carbetapentane should be used with caution insedated patients, and in patients confined to thesupine position. INFORMATION FORPATIENTS: Caution patients against drinkingalcoholic beverages or engaging in potentiallyhazardous activities requiring alertness, such asdriving a car or operating machinery, whileusing this product. Patients should be warnednot to use this product if they are now taking aprescription monoamine oxidase (MAO) inhibitor(certain drugs for depression, psychiatric oremotional conditions, or Parkinson’sdisease), or for 2 weeks after stopping the MAOinhibitor drug. If patients are uncertain whether aprescription drug contains an MAO inhibitor, theyshould be instructed to consult a healthprofessional before taking this product.

DRUG INTERACTIONSMAO inhibitors may prolong and intensify theanticholinergic effects of antihistamines and theoverall effects of sympathomimetic agents.Patients may develop hyperpyrexia,hypotension, nausea, myoclonic leg jerks, andcoma following co-administration of MAOinhibitors and Carbetapentane. Thus,concomitant administration of VAZOTANTANNATE SUSPENSION and MAO inhibitorsshould be avoided (see“CONTRAINDICATIONS”). CARCINOGENESIS,MUTAGENESIS, IMPAIRMENT OF FERTILITYNo long-term animal studies have beenperformed with VAZOTAN TANNATESUSPENSION.PREGNANCY: Teratogenic Effects – Pregnancy

Category C Animal reproduction studies havenot been conducted with VAZOTAN TANNATESUSPENSION. It is also not known whetherVAZOTAN TANNATE SUSPENSIONcan cause fetal harm when administered to apregnant woman or can affect reproductioncapacity. VAZOTAN TANNATE SUSPENSIONshould be given to a pregnant woman only ifclearly needed.3 4 5 6 7 8 9 0LABOR AND DELIVERY: Administration ofPhenylephrine to patients in late pregnancyor labor may cause fetal anoxia or bradycardiaby increasing contractility of the uterus anddecreasing uterine blood flow. NURSINGMOTHERS: Because of the higher risk ofintolerance of antihistamines in small infantsgenerally, and in newborns and prematuresin particular, VAZOTAN TANNATESUSPENSION should not be administered to anursing mother. Phenylketonurics: ContainsPhenylalanine 8.419 mg per 5 mL.

ADVERSE REACTIONSThe most common effects associated withantihistamines have been drowsiness, sedation,dryness of mucous membranes, andgastrointestinal effects. Serious sideeffects with oral antihistamines,sympathomimetics, and antitussives have beenrare. 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 - urinaryfrequency, difficult urination. Gastrointestinal -epigastric discomfort, anorexia, nausea,vomiting, diarrhea, constipation.Respiratory - tightness of chest and wheezing,shortness of breath. Hematologic – hemolyticanemia, thrombocytopenia, agranulocytosis.

OVERDOSAGESIGNS AND SYMPTOMS: May vary from CNSdepression to stimulation (restlessness toconvulsions). Antihistamine overdosage in youngchildren may lead to convulsions and death.Atropine-like signs and symptoms may beprominent. Carbetapentane may producecentral excitement and mental confusion. TREATMENT: Induce vomiting if it has notoccurred spontaneously. Precautionsmust be taken against aspiration especially ininfants, children, and comatose patients. Ifgastric lavage is indicated, isotonic or half-isotonic saline solution is preferred.Stimulants should not be used. If hypotension isa problem, vasopressor agents may beconsidered.

DOSAGE AND ADMINISTRATIONVAZOTAN TANNATE SUSPENSION:Administer the recommended dose every 12 hours. 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 5mL of VAZOTAN Tannate Suspensioncontains: 6mg Brompheniramine Maleate, 10mgPhenylephrine HCl and 25mg CarbetapentaneCitrate in a tannate suspension.

Note: The Hydrochloride salt of Phenylephrine,the Maleate salt of Brompheniramine, and theCitrate salt of Carbetapentane are provided in aTannate supspension by means of the TCTmanufacturing process. This yields acorresponding 20 mg of Phenylephrine Tannate,12 mg of Brompheniramine Tannate, and 50 mgof Carbetapentane Tannate per dose.U.S. Patent # 6,869,618

HOW SUPPLIEDVAZOTAN TANNATE SUSPENSIONSuspension: (Phenylephrine HCl 10 mg,Brompheniramine Maleate 6 mg,and Carbetapentane Citrate 25 mg per 5 mL) isavailable in a bubble gum flavored suspensionin 4 fl. oz. bottles. NDC No.: 66992-220-04; andin 15 mL NDC No.: 66992-220-01 samplebottles. Store at controlled room temperature,20°-25°C (68°-77°F). Dispense in a tight, light-resistant container (USP/NF) with achild-resistant closure.

Rx Only

Patent # 6,869,618

Utilizing TCT (Tannate Conversion Technology)

Marketed ByWraSer Pharmaceuticals.,Madison, MS 39110

Brompheniramine Maleate 6 mgPhenylephrine HCl 10 mgCarbetapentane Citrate 25 mg

TANNATE SUSPENSION

The Cough Suppressant for Working and Active People

n 12 hour reliefn Utilizes a unique

patented TCT tecnologyn Convenient BID dosingn Strongest Non-Narcotic

cough suppressantn 1(1/2) times as effective

as codeinen Great Bubble Gum Flavor!

12 HourPowerful Relief12 HourPowerful Relief

VAZOTAN DOSAGE

AND ADMINISTRATION

OVER 12 YEARS OF AGE 2 TSP. B.I.D.

CHILDREN 6-12 YEARS OF AGE 1 TSP. B.I.D.

CHILDREN 2-6 YEARS OF AGE 1/2 TSP. B.I.D.

CHILDREN UNDER 2 YEARS OF AGE- CONSULT PHYSICIAN

Brompheniramine Maleate 6 mgPhenylephrine HCl 10 mgCarbetapentane Citrate 25 mg

TANNATE SUSPENSION