Prescription Drugs

CLINICAL PHARMACOLOGY Histinex® HC (phenylephrine, hydrocodone, cpm) reduces excessive nasal secretions, diminishes edema of the nasal mucosa and congestion of the upper respiratory tract and abolishes or diminishes cough. The antihistaminic action of chlorpheniramine maleate reduces or abolishes allergenic responses of nasal tissue. Its action is complemented by the mild vasoconstrictor action of phenylephrine hydrochloride which provides a nasal decongestant effect. Cough suppression is a result of the action of hydrocodone bitartrate.

Histinex® HC (antitussive/nasal decongestant/antihistamine) Syrup DESCRIPTION Histinex® HC (phenylephrine, hydrocodone, cpm) is a clear, orange-colored, sugar free, alcohol free syrup with characteristic fruity odor for oral administration. Each teaspoonful (5 mL) contains: Hydrocodone Bitartrate* ............................................2.5 mg Phenylephrine Hydrochloride ......................................5.0 mg Chlorpheniramine Maleate ........................................2.0 mg Antitussive/nasal decongestant/antihistamine syrup for oral administration. Also contains citric acid, FD&C Yellow No. 6 (Sunset Yellow), flavorings, glycerin, hydrochloric acid, maltitol solution, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium hydroxide, sodium phosphate dibasic and sorbitol solution. *(Warning: May be habit forming)

INDICATIONS Histinex® HC (phenylephrine, hydrocodone, cpm) is indicated for the symptomatic relief of cough, nasal congestion and discomfort associated with upper respiratory tract infections. DOSAGE AND ADMINISTRATION Adults and pediatric patients over 12 years - 2 teaspoonsful (10 mL) every 4 hours, not to exceed 8 teaspoonsful in 24 hours. Pediatric patients 6 to 12 years - 1 teaspoonful (5 mL) every 4 hours, not to exceed 4 teaspoonsful in 24 hours. Pediatric patients under 6 years - use only as directed by a physician. HOW SUPPLIED Bottles of 16 fl. oz. (473 mL) NDC 58177-877-07 Bottles of 32 fl. oz. (946 mL) NDC 58177-877-12 KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Store at controlled room temperature, 59°-86°F (15°-30°C) Dispense in tight, child resistant, light-resistant containers as defined by the USP/NF. Manufactured by: KV Pharmaceutical Co. for ETHEX Corporation St. Louis, MO 63043-2413. Rev. 10/98.

PATIENT INFORMATION No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

OVERDOSE No information provided. CONTRAINDICATIONS Hypersensitivity to antihistamines of the same chemical class. Histinex® HC is contraindicated during pregnancy and in concurrent therapy with MAO inhibitors. Because of its drying effect on lower respiratory secretions, Histinex® HC is not recommended in the treatment of bronchial asthma.

SIDE EFFECTS Adverse reactions to Histinex® HC (phenylephrine, hydrocodone, cpm) may include hypersensitivity reactions such as rash, urticaria, leukopenia, agranulocytosis and thrombocytopenia, drowsiness, lassitude, giddiness, dryness of the mucous membranes, tightness of the chest, thickening of bronchial secretions, urinary frequency and dysuria, palpitation, hypertension/hypotension, headache, faintness, dizziness, tinnitus, incoordination, visual disturbances, mydriasis, CNS depressant and (less often) stimulant effect, increased irritability or excitement, anorexia, nausea, vomiting, diarrhea, constipation and epigastric distress. Drug Abuse And Dependence This product is a Schedule III Controlled Substance. Because of the hydrocodone content, some abuse might be expected. Psychic dependence, physical dependence and tolerance may deveolop upon repeated administration. It should be prescribed and administered with the degree of caution appropriate for this type product. DRUG INTERACTIONS No information provided.

WARNINGS No information provided. PRECAUTIONS Administer with care in patients with cardiac or peripheral vascular diseases or hypertension. Until the patient's response has been determined, he should be cautioned against engaging in operations which require alertness, such as driving an automobile, operating machinery, etc. Patients receiving antihistamines should be warned against possible additive effects with CNS depressants such as alcohol, hypnotics, sedatives, tranquilizers, etc. Since hydrocodone may produce drowsiness, persons who perform hazardous tasks requiring mental alertness or physical coordination should be cautioned accordingly. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with Histinex® HC (phenylephrine, hydrocodone, cpm) Syrup. Pregnancy Teratogenic Effects. Pregnancy category C. Animal reproduction studies have not been conducted with Histinex® HC (phenylephrine, hydrocodone, cpm) Syrup. It is also not known whether Histinex® HC (phenylephrine, hydrocodone, cpm) Syrup can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Histinex® HC (phenylephrine, hydrocodone, cpm) 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 and because of the potential for serious adverse reactions in nursing infants from Histinex® HC (phenylephrine, hydrocodone, cpm) Syrup, a decision should be made whether to discontinue nursing or discontinue the drug, taking into the account the importance of the drug to the mother. Pediatric Use Safety and effectiveness in pediatric patients below the age of 6 has not been established. Geriatric Use Clinical studies of Histinex® HC (phenylephrine, hydrocodone, cpm) syrup did not include sufficient numbers of subjects aged 65 and over to determine whetherthey respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of Histinex® HC (phenylephrine, hydrocodone, cpm) syrup and observed closely.