{"adverse_reactions":["6 ADVERSE REACTIONS Adverse reactions include drowsiness, lassitude, nausea, giddiness, constipation, respiratory depression, addiction, dryness of mouth, blurred vision, cardiac palpitations, flushing, increased irritability or excitement (especially in children)."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY Chlorpheniramine maleate is an alkylamine type antihistamine. This group of antihistamine are among the most active histamine antagonists are generally effective in relatively low doses. The drugs are not so prone to produce drowsiness and are among the most suitable agents for daytime use, but a significant proportion of the patients do experience this effect. Pseudoephedrine HCI is a sympathomimetic which acts predominately alpha receptors and has little action on beta receptors. It therefore functions as an oral nasal decongestant with minimal CNS stimulation. Hydrocodone bitartrate is a potent antitussive which causes suppression of the cough reflex by direct action on the cough center. Hydrocodone is approximately three times as potent as codeine on weight basis and has a higher addiction potential also."],"contraindications":["4 CONTRAINDICATIONS Hypersensitivity to antihistamines, sympathomimetic amines, or hydrocodone. Patients known to be hypersensitive to other opioids may exhibit cross sensitivity to this product. Hydrocodone is contraindicated in the presence of increased intracranial pressure and whenever ventilatory function is depressed. Antihistamines are contraindicated in patients receiving antihypertensive or antidepressant drugs containing monoamine oxidase (MAO) inhibitors since these agents may prolong and intensify the anticholinergic and CNS depressant effects of antihistamines (see Drug Interactions). Antihistamines should not be used to treat lower respiratory tract symptoms or be given to premature or newborn infants. Sympathomimetic agents are contraindicated in patients with severe hypertension, severe coronary artery disease and in those taking MAO inhibitors. This product is contraindicated in patients with severe hypertension, severe coronary artery disease, patients with narrow-angle glaucoma, bronchial asthma, urinary retention, peptic ulcer and during an asthma attack. This product is contraindicated in women who are pregnant."],"dosage_and_administration":["2 DOSAGE & ADMINISTRATION Adults and adolescents over 12 years. 1 to 2 teaspoonfuls. Children 6 to 12 years of age – ½ to 1 teaspoonful. Children 2 to 6 years of age – ¼ to ½ teaspoonful. These doses maybe given four times daily as needed. Not recommended for children under 2 years of age."],"drug_abuse_and_dependence":["9 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 develop upon repeated administration. It should be prescribed and administered with appropriate caution."],"drug_interactions":["7 DRUG INTERACTIONS MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics. Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine, reserpine and veratrum alkaloids. Concomitant use of narcotics and antihistamines with alcohol and other CNS depressants may have and additive effect. Pregnancy: Pregnancy Category C: Animal reproductive studies have not been conducted with this product. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed. Labor and Delivery : As with all narcotics, administration of the product to the mother shortly before delivery may result in some degree of respiratory depression in the newborn especially if high doses are used. Nonteratogenic Effects: Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Chlorpromazine 0.7- 1.0 mg/kg q6h, Phenobarbital 2 mg/kg q6h, and paregoric 2-4 drops/kg g4h, have been used to treat withdrawal symptoms in infants. The duration of therapy is 4 to 28 days, with the dosage decreased as tolerated. 3 NURSING MOTHERS Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers. 4 PEDIATRIC USE This product is not recommended for use in children under two years of age. Narcotic antitussives are not recommended for use in children under two years of age. Children under two years may be more susceptible to the respiratory arrest, coma and death. Use of antihistamines is not recommended in infants. This age group may be at a higher risk than other age groups because of an increased susceptibility to anticholinergic effects, such as CNS excitation, and an increased tendency toward convulsions. In older children taking antihistamines, a paradoxical reaction characterized by hyperexcitability may occur. Very young children may be more sensitive to the effects, especially the vasopressor effects of sympathomimetic amines."],"effective_time":"20110201","how_supplied":["16 HOW SUPPLIED A clear liquid with a grape aroma supplied in 16 oz bottle (NDC 66993-500-57). Storage: Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in a tight, light resistant container as defined in the USP/NF. Manufactured for: Prasco Laboratories Cincinnati, Ohio 45249 USA Manufactured by: Sovereign Pharmaceuticals, Ltd. Fort Worth, TX 76118 Iss. 07/04 500162"],"id":"92480fe8-e378-4202-8364-bed74911529c","indications_and_usage":["1 INDICATIONS & USAGE WellTuss HC is indicated for the temporary relief of cough and nasal congestion associated with upper respiratory tract infections and allergies."],"information_for_patients":["17 INFORMATION FOR PATIENTS Antihistamines and hydrocodone may cause drowsiness and ambulatory patients who operate machinery or motor vehicles should be cautioned accordingly."],"openfda":{},"overdosage":["10 OVERDOSAGE Symptoms of overdosage include respiratory depression, extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin and other symptoms common with narcotic overdosage. Primary treatment consists of insuring adequate respiration through provision of a paten airway and the institution of assisted or controlled ventilation. Naloxone hydrochloride should be administered in small intravenous doses (consult specific product labeling before use). In addition, oxygen, intravenous fluids, basopressors and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug. Activated charcoal may also be of benefit."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 92480fe8-figure-01"],"precautions":["PRECAUTIONS General: Caution should be exercised in patients with high blood pressure, heart disease, diabetes or thyroid disease. The hydrocodone and antihistamine in this product may exhibit additive effects with other CNS depressants, including alcohol. Respiratory depression can be a real hazard so caution should be used, especially in patients with chronic obstructive pulmonary disease."],"set_id":"cfae8153-3cf8-4cb2-b71d-2062b1db1e37","spl_product_data_elements":["WellTuss HC hydrocodone bitartrate, chlorpheniramine maleate, pseudoephedrine hydrochloride HYDROCODONE BITARTRATE HYDROCODONE CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE BENZOIC ACID CITRIC ACID MONOHYDRATE PROPYLENE GLYCOL SACCHARIN SODIUM WATER grape aroma"],"version":"1","warnings":["WARNINGS Hydrocodone can produce drug dependence and therefore has the potential for being abused. This product should be prescribed and administered with the appropriate degree of caution. Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic heart disease, hyperthyroidism, increased intraocular pressure and prostatic hypertrophy. The elderly (60 years and older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability, especially in children. At dosages higher that the recommended dose, nervousness, dizziness or sleeplessness may occur."]}