{"adverse_reactions":["ADVERSE REACTIONS Adverse effects associated with Rynesa 12S Suspension at recommended doses have been minimal. The most common have been drowsiness, sedation, dryness of mucous membranes, and gastrointestinal effects. Serious side effects with oral antihistamines or sympathomimetics have been rare."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Rynesa 12S Suspension combines the sympathomimetic decongestant effect of phenylephrine with the antihistaminic action of pyrilamine."],"contraindications":["CONTRAINDICATIONS Rynesa 12S Suspension is contraindicated for newborns, nursing mothers, and patients sensitive to any of the ingredients or related compounds."],"description":["DESCRIPTION Rynesa 12S Suspension is an antihistamine/nasal decongestant combination available for oral administration as a Suspension . Each 5mL (one teaspoonful) of the pink colored cherry berry flavored suspension contains: Pyrilamine Tannate 30 mg Phenylephrine Tannate 5 mg Other ingredients: Carboxymethylcellulose sodium, anhydrous citric acid, FD&C Red #3, glycerin, methylparaben, microcrystalline cellulose, natural & artificial cherry berry flavor, saccharin sodium, sodium benzoate, sodium citrate, sucrose, titanium dioxide, xanthan gum, purified water."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Administer the recommended dose every 12 hours. RYNESA 12S Suspension: Children over six years of age – 5 to 10 mL (1 to 2 teaspoonfuls) Children two to six years of age – 2.5 to 5 mL (1/2 to 1 teaspoonful) Children under two years of age – Titrate dose individually."],"effective_time":"20110413","how_supplied":["HOW SUPPLIED RYNESA 12S Suspension (pyrilamine tannate 30 mg and phenylephrine tannate 5 mg per 5 mL) is available in 4 fl oz (118 mL) and 16 fl oz (473 mL) bottles. Store at 20° - 25° C (68° - 77° F); excursions permitted to 15° - 30° C (59° - 86° F). [See USP Controlled Room Temperature]. SHAKE WELL BEFORE USING. Rx Only"],"id":"fe93c374-aabb-4194-800c-ea79f5fc04f8","indications_and_usage":["INDICATIONS AND USAGE Rynesa 12S Suspension is indicated for symptomatic relief of the coryza and 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."],"openfda":{},"overdosage":["OVERDOSAGE Signs & symptoms: May vary from CNS depression to stimulation (restlessness to convulsions). Antihistamine overdosage in young children may lead t 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."],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL fe93c374-figure-01 fe93c374-figure-02"],"precautions":["PRECAUTIONS General: Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients. Antihistamines may cause excitation, particularly in children, but their combination with sympathomimetics may cause either mild stimulation or mild sedation. 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 inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If patients are uncertain whether a prescription drug contains an MAOI, they should be instructed to consult a health professional before taking such a product. Drug Interactions: MAOI inhibitors may prolong and intensify the anticholinergic effects of antihistamines and the overall effects of sympathomimetic agents. Carcinogenesis, mutagenesis, impairment of fertility: No long term animal studies have been performed with Rynesa 12S Suspension. Pregnancy: Teratogenic effects: Pregnancy Category C. Animal reproduction studies have not been conducted with Rynesa 12S Suspension. It is also not known whether Rynesa 12S Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Rynesa 12S Suspension should be given to a pregnant woman only if clearly needed. Nursing mothers: Rynesa 12S Suspension should not be administered to a nursing woman."],"set_id":"e42dc056-3c7d-4fe0-b9a8-45c10574f750","spl_product_data_elements":["Rynesa 12S Suspension Pyrilamine Tannate and Phenylephrine Tannate PYRILAMINE TANNATE PYRILAMINE PHENYLEPHRINE TANNATE PHENYLEPHRINE CARBOXYMETHYLCELLULOSE SODIUM ANHYDROUS CITRIC ACID FD&C RED NO. 3 GLYCERIN METHYLPARABEN CELLULOSE, MICROCRYSTALLINE SACCHARIN SODIUM SODIUM BENZOATE SODIUM CITRATE SUCROSE TITANIUM DIOXIDE XANTHAN GUM WATER"],"spl_unclassified_section":["Rx only","Manufactured by: Distributed by: Amneal Pharmaceuticals Amneal Pharmaceuticals Branchburg, NJ 08876 Glasgow, KY 42141 Made in the U.S.A. MF#649 Rev. 01-2008"],"version":"4","warnings":["WARNINGS Use with caution in patients with hypertension, cardiovascular disease, hyperthyroidism, diabetes, narrow angle glaucoma, or prostatic hypertrophy. Use with caution or avoid use in patients taking monoamine oxidase (MAO) inhibitors, or within 14 days of stopping such treatment. This product contains an antihistamine which may cause drowsiness and may have additive central nervous system (CNS) effects with alcohol or other CNS depressants (e.g., hypnotics, sedatives, tranquilizers)."]}