{"adverse_reactions":["ADVERSE REACTIONS: The following adverse reactions have been observed with the use of chlorpheniramine and scopolamine methyl nitrate; Arrhytmias, blood dyscrasias, CNS depression, CNS stimulation, dizziness, drowsiness, dryness of mouth, hallucinations, hypotension, hypertension, increased sweating, loss of appetite, paradoxical reaction, restlessness, skin rash, stomach upset or pain, thickening of mucus, tingling in hands or feet, trembling, troubled breathing, unusual tiredness or weakness, vomiting. Note: Agitation; confusion; difficult or painful urination; drowsiness; dizziness; and dryness of mouth, nose and throat are more likely to occur in the elderly. Nightmares, unusual excitement, nervousness, restlessness, or irritability are more likely to occur in children and the elderly. When anticholinergics are given to patients, especially children, where the environmental temperature is high, there is risk of a rapid increase in body temperature."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No data is available on the long-term potential of the components of this product for Carcinogenesis, Mutagenesis or Impairment of Fertility in animals or humans."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY: Chlorpheniramine maleate competitively antagonizes most of the smooth muscle stimulating actions of histamine on the H1 receptors of the GI tract, uterus, large blood vessels, and bronchial muscle. It also antagonizes the action of histamine that results in increased capillary permeability and the formation of edema. Chlorpheniramine maleate is analkylamine-type antihistamine. This group of antihistamines are among the most active histamine antagonists and are generally effective in relatively low doses. They thereby prevent, but do not reverse, responses mediated by histamine alone. The anticholinergic actions of most antihistamines provide a drying effect on the nasal mucosa. These drugs are not so prone to produce drowsiness and are among the most suitable agents for daytime use, but a significant proportion of patients do experience this effect. Scopolamine methyl nitrate is one of the principal anticholinergic/antispasmodic components of belladonna alkaloids that exhibits antisecretory activity. Scopolamine methyl nitrate inhibits the muscarinic actions of acetylcholine on structures innervated by postganglionic cholinergic nerves: smooth muscle, cardiac muscle, sinoatrial and atrioventricular nodes, and exocrine glands. In general, the smaller doses of anticholinergics inhibit salivary and bronchial secretions, sweating, and accommodation; cause dilation of the pupil; and may affect the heart rate."],"contraindications":["CONTRAINDICATIONS: This product is contraindicated in patients with hypersensitivity or idiosyncrasy to any of its ingredients. It is also contraindicated in women who are pregnant or nursing. It is also contraindicated in newborn or premature infants, because this age group has an increased susceptibility to the anticholinergic side effects of chlorpheniramine maleate. Geriatric patients may be more sensitive to the effects of this medication. Risk-benefit should be considered when the following conditions exist: Acute asthma; Bladder neck obstruction; Brain damage in children; Cardiac disease, especially cardiac arrhythmias, congestive heart failure, coronary artery disease, and mitral stenosis; Cardiovascular disease; Diabetes mellitus; Down’s Syndrome; Esophagitis, reflux; Narrow angle glaucoma; Acute hemorrhage with unstable cardiovascular status; Hepatic function impairment; Hernia; Hypertension; Hyperthyroidism; Intestinal atony in the elderly or debilitated patient; Chronic lung disease; Myasthenia gravis; Autonomic neuropathy; Paralytic ileus; Prostatic hypertrophy; Psychiatric disorders; Pyloric obstruction; Renal function impairment; Spastic paralysis, in children; Tachycardia; Toxemia of pregnancy; Ulcerative colitis; Urinary retention, or predisposition to; Uropathy; Xerostomia."],"description":["DESCRIPTION: Each teaspoonful (5 mL) for oral administration contains: Chlorpheniramine Maleate ...................................... 4 mg Scopolamine Methyl Nitrate .............................. 1.25 mg INACTIVE INGREDIENTS: Citric Acid, Grape flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Citrate, Sodium Saccharin, and Sorbitol. RYNEZE® LIQUID contains ingredients from the following classes: antihistamine, and anticholinergic. Chlorpheniramine Maleate is an antihistamine with the chemical name: 2-Pyridinepropanamine, γ-(4-chlorphenyl)- N,N -dimethyl-, (Z)-2-butenedioate (1:1), and has the following chemical structure: Chlorpheniramine Maleate structure: Scopolamine Methyl Nitrate is an anticholinergic belldonna alkaloid derivative with the chemical name: [7(s)-(α,2β,4β,5α,7β,)]–7–(3–hydroxy–1-oxo – 2- Phenylpropoxy)-9, 9-dimethyl–3-oxa– 9-azoniatricyclo [3.3.1.0 2,4] nonane nitrate.It has the following chemical structure: Scopolamine Methyl Nitrate: Chlorpheniramine Maleate structure Scopolamine Methyl Nitrate"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: Adults and children 12 years of age and older: 1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours. Children 6 to under 12 years of age: ½ teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours. RYNEZE® LIQUID is not recommended for children under 6 years of age. Note: Geriatric patients may be more sensitive to the effects of the usual adult dose. Adjust adult dose accordingly."],"drug_interactions":["Drug Interactions: Do not take this product if you are presently taking, or have taken within the preceding two weeks, a prescription drug for high blood pressure or depression without first consulting your physician. Absorption of other oral medications may be decreased during concurrent use with anticholinergics due to decreased gastrointestinal motility and delayed gastric emptying. Combinations containing any of the following medications, depending on the amount present, may also interact with this product: • Alkalizers, such as: calcium and/or magnesium-containing antacids; Carbonic inhibitors; citrates; sodium bicarbonate-urinary excretion of anticholinergics may be delayed by alkalization of the urine, thus potentiating scopolamine methyl nitrate therapeutic and/or side effects. • Antacids or adsorbent antidiarrheals-simultaneous use of these medications may reduce absorption of scopolamine methyl nitrate, resulting in decreased therapeutic effectiveness; doses of these should be spaced 2 or 3 hours apart from doses of scopolamine methyl nitrate. • Anticholinergics – Concurrent use with anticholinergic effects; patients should be advised to report occurrence of gastrointestinal problems promptly since paralytic ileus may occur with concurrent therapy. • CNS Depressants – Concurrent use of alcohol, antihistamines with alcohol, tricyclic antidepressants, barbiturates and other CNS depressants may have an additive effect. • Ketoconazole – Anticholinergics may increase gastrointestinal pH, possibly resulting in a marked reduction in ketoconazole absorption during concurrent use with anticholinergics; patients should be advised to take these medications at least 2 hours after ketoconazole. • MAO inhibitors – Concurrent use may prolong and intensify cardiac stimulate and vasopressor effects of chlorpheniramine, resulting in headache, cardiac arrhythmias, vomiting or sudden and severe hypertensive and/or hyperpyretic crisis. These medications should not be administered during or within 14 days following the administration of MAO inhibitor therapy. • Metoclopramide – Concurrent use of metoclopramide with anticholinergics may antagonize metoclopramide’s effects on gastrointestinal motility. • Potassium chloride – Concurrent use with anticholinergics may increase the severity of potassium chloride-induced gastrointestinal lesions."],"effective_time":"20170926","geriatric_use":["Geriatric Use: Geriatric patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion. Geriatric patients are especially susceptible to the anticholinergic side effects, such as constipation, dryness of the mouth, and urinary retention (especially in males). If these side effects occur and continue or are severe, medication should probably be discontinued. Caution is also recommended when anticholinergics are given to geriatric patients, because of the danger of precipitating undiagnosed glaucoma. Memory may become severely impaired in geriatric patients, with the continued use of anticholinergics, since these drugs block the action of acetylcholine, which is responsible for many functions of the brain, including memory function."],"how_supplied":["HOW SUPPLIED: RYNEZE® LIQUID is supplied as a clear, grape-flavored liquid, dye free, sugar free, alcohol free, and gluten free in 16 fl oz (473 mL) bottles, NDC 24839-346-16, and 10 mL sample, NDC 24839-346-10 KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, CALL A DOCTOR OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Pharmacist: Store at controlled room temperature, 15°-30°C (59°-86°F). Avoid exposure to heat. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Manufactured For: SJ pharmaceuticals 4200 Northside Pkwy NW, Building 12 Atlanta, GA 30327 Manufactured By: Great Southern Laboratories Houston, TX 77099 Rev. 06/09"],"id":"0fd145d9-026c-4a5f-97a7-b9de0bc102d7","indications_and_usage":["INDICATIONS AND USAGE: This product is indicated for the temporary relief of symptoms associated with seasonal and perennial allergic and non-allergic rhinitis, and sinusitis.Chlorpheniramine Maleate temporarily relieves runny nose and reduces sneezing, itching of the nose or throat, and itchy,watery eyes due to hay fever or other upper respiratory allergies. Scopolamine Methyl Nitrate further augments the anti-secretory activity of this product."],"information_for_patients":["Information for patients: Patient consultation should include the following information regarding proper use of this medication: • Do not take more medication than the amount recommended. • This medication should be used with caution during exercise or hot weather, overheating may result in heat stroke. • Do not drive or operate machinery if drowsiness or dizziness occurs. • Do not ingest alcoholic beverages, monoamine oxidase (MAO) inhibitors, or CNS depression producing medications (hypnotics, sedatives, tranquilizers) while taking this medication. • This medication possibly increases sensitivity of eyes to light. • Scopolamine methyl nitrate may cause blurred vision. • If a dose is missed, the medication should be taken as soon as possible unless it is almost time for the next dose. Do not double dose. Caution patients about the signs of potential side effects, especially: • Anticholinergic effects – clumsiness or unsteadiness;severe drowsiness; severe dryness of mouth, nose, or throat; flushing or redness of face; shortness of breath or trouble breathing. • Blood dyscrasias-sore throat and fever; unusual bleeding or bruising; unusual tiredness or weakness. • Fast or irregular heartbeat. • Psychotic episodes. • Tightness in chest. Note: When anticholinergics are given to patients, especially children, where the environmental temperature is high there is a risk of a rapid increase in body temperature because of suppression of sweat gland activity. Infants, patients with Down’s syndrome, and children with spastic paralysis or brain damage may show an increased response to anticholinergics, thus increasing the potential for side effects. Geriatric or debilitated patients may respond to usual doses of anticholinergics with excitement, agitation, drowsiness, or confusion."],"laboratory_tests":["Laboratory Tests: The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on conditions): Blood pressure determination – recommended at frequent intervals during therapy: Electrocardiogram (ECG) – monitoring may be required: Intraocular pressure determination – recommended at periodic intervals, as these medications may increase the intraocular pressure."],"nursing_mothers":["Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ryneze Liquid is administered to a nursing woman."],"openfda":{},"overdosage":["OVERDOSAGE: In all cases of suspected overdose, immediately call your regional poison center and/or contact a physician immediately. The stomach should be emptied promptly by lavage or induction of emesis with syrup of ipecac. The installation of activated charcoal into he stomach also should be considered. The treatment of overdose is essentially sypmptomatic and supportive. If respiratory depression is present treat promptly with oxygen and/or mechanical support of ventilation. If convulsions or marked CNS excitement occurs, only short-acting benzodiazepine-type drugs should be used."],"package_label_principal_display_panel":["PRODUCT PACKAGING: The packaging below represents the labeling currently used. Ryneze ® Liquid Antihistamine/Anticholinergic Each 5 mL (one teaspoonful) for oral administration contains: Chlorpheniramine Maleate ...... 4 mg Scopolamine Methyl Nitrate .... 1.25 mg Rx Only Dye Free/Sugar Free Alcohol Free/Gluten Free Grape Flavor 16 fl oz (473 mL) DOSAGE AND ADMINISTRATION: Adults and children 12 years of age and older:1 teaspoonful (5 mL) every 4 to 6 hours, not to exceed 6 teaspoonfuls in 24 hours. Children 6 to under 12 years of age: 1/2 teaspoonful (2.5 mL) every 4 to 6 hours, not to exceed 3 teaspoonfuls in 24 hours. RYNEZE® LIQUID is not recommended for children under 6 years of age. THIS BOTTLE IS NOT TO BE DISPENSED TO THE CONSUMER. Note : Geriatric patients may be more sensitive to the effects of the usual adult dose. Adjust adult dose accordingly. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, CALL A DOCTOR OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Pharmacist:Store at controlled room temperature, 15 o -30 o C (59 o -86 o F). Avoid exposure to heat. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure. Manufactured for: SJ Pharmaceuticals 4200 Northside Parkway, NW Building 12 Atlanta, GA 30327 Manufactured by: Great Southern Laboratories Houston, TX 77099 Rev. 06/09 Ryneze packaging Ryneze packaging Ryneze Packaging Ryneze packaging Ryneze packaging Ryneze packaging Ryneze packaging"],"pediatric_use":["Pediatric Use: Safety and effectiveness of Ryneze® Liquid in children below the age of 6 have not been established. Use is not recommended for children under six years of age. A paradoxical reaction characterized by hyperexcitability may occur in children taking large doses of anticholinergics."],"precautions":["PRECAUTIONS: General: Antihistamines have an atropine-like action and should be used with caution in patients with a history of bronchial asthma, emphysema, increased intraocular pressure, hyperthyroidism, cardiovascular disease and hypertension. Use scopolamine methyl nitrate with caution in patients with hiatal hernia associated with reflux Esophagitis. Use extreme caution and only when needed in patients with autonomic neuropathy, hyperthyroidism, coronary heart disease, congestive heart failure, and cardiac arrhythmia."],"pregnancy":["Pregnancy: Category C: It is not known whether Ryneze® Liquid can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Ryneze® Liquid should be given to a pregnant woman only if clearly needed."],"set_id":"9aca3d25-d042-479b-a00e-63be5b5073fe","spl_product_data_elements":["Ryneze Liquid Chlorpheniramine maleate, Scopolamine Methyl Nitrate CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE METHSCOPOLAMINE NITRATE METHSCOPOLAMINE"],"version":"5","warnings":["WARNINGS: This product may cause drowsiness or blurred vision. Patients taking this product should be warned not to engage in activities requiring mental alertness such as operating a motor vehicle or other machinery or to perform hazardous tasks while taking this drug. Do not exceed recommended dosage. Heat prostration can occur with the use of scopolamine methyl nitrate when the environmental temperature is high. Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy; in this instance, use of scopolamine methyl nitrate would be inappropriate and possibly harmful."]}