{"adverse_reactions":["ADVERSE REACTIONS: Guaifenesin is well tolerated and has a wide margin of safety. Side effects are generally mild and infrequent. Nausea and vomiting are the most common side effects. Dizziness, headache, and rash (including urticaria) have been reported rarely."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY: No adequate and well controlled studies have been conducted to determine whether the components of EXPECTUSS LIQUID have a potential for carcinogenesis, mutagenesis, or impairment of fertility."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY: Carbetapentane citrate is a centrally acting non-narcotic antitussive. Guaifenesin is an expectorant. Its action increases the output of respiratory tract fluid by reducing adhesiveness and surface tension. Sinus and bronchial drainage is improved and dry, nonproductive coughs become more productive and less frequent."],"contraindications":["CONTRAINDICATIONS: EXPECTUSS LIQUID is contraindicated in infants, newborns, and in patients with a known hypersensitivity to any of the components. It is also contraindicated in patients on MAO inhibitor therapy."],"description":["Description: EXPECTUSS Liquid is an alcohol-free, sugar-free, purple liquid for oral administration having a grape odor and flavor. Each Teaspoon (5 mL) Contains: CARBETAPENTANE CITRATE 20 mg GUAIFENESIN 75 mg"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: EXPECTUSS LIQUID is administered orally as follows: Adults: 1-2 teaspoonfuls every 4-6 hours or as directed by a physician. Children 6-12 years of age: 1 teaspoonful every 4-6 hours or as directed by a physician. Children 6 years of age and under: as directed by a physician."],"effective_time":"20160502","how_supplied":["How supplied: 16 fluid ounce bottles NDC# 23359-003-16 KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSAGE, CONTACT A POISON CONTROL CENTER AND SEEK PROFESSIONAL ASSISTANCE IMMEDIATELY. Store between 59 o -86 o F (15 o -30 o C). DISPENSE IN TIGHT, LIGHT RESISTANT CONTAINERS WITH CHILD RESISTANT CLOSURES AS DEFINED IN THE USP/NF. Manufactured for: Centurion Labs, LLC. Birmingham, AL 35243 For Professional Use Consult a Physician Rev. 7/09"],"id":"b698c0a9-b5d0-475e-9cb6-961ba810a3ab","indications_and_usage":["INDICATIONS AND USAGE: For temporary relief of non-productive cough accompanying respiratory tract congestion associated with the common cold, influenza, sinusitis, and bronchitis."],"nursing_mothers":["NURSING MOTHERS: Due to the possible passage of the ingredients into breast milk, this product should not be given to nursing mothers."],"openfda":{},"overdosage":["OVERDOSAGE: SIGNS AND SYMPTOMS: Incidence of acute toxicity with guaifenesin is low and over dosage is unlikely to produce serious toxic effects. In laboratory animals no toxicity resulted when guaifenesin was administered by stomach tube in doses up to 5 grams/kg. TREATMENT: Treatment of the signs and symptoms of overdosage is symptomatic and supportive. The patient should be induced to vomit, even if emesis has occurred spontaneously. Pharmacologic vomiting by the administration of ipecac syrup is a preferred method, however, vomiting should not be induced in patients with impaired consciousness. Precautions against aspiration must be taken, especially in infants and children. Following emesis, any drug remaining in the stomach may be absorbed by activated charcoal administered as a slurry with water."],"package_label_principal_display_panel":["PRODUCT PACKAGING: The packaging below represents the labeling currently used: NDC 23359-003-16 EXPECTUSS Liquid ANTITUSSIVE/EXPECTORANT Each 5 mL (1 teaspoon) contains: Carbetapentane Citrate..... 20 mg Guaifenesin...................... 75 mg SUGAR FREE ALCOHOL FREE Rx Only 1 PINT (473 mL) CENTURION LABS Side Panels: USUAL DOSAGE: Adults: 1-2 teaspoonfuls every 4 to 6 hours or as directed by a physician. Children 6-12 years of age: 1 teaspoonful every 4 to 6 hours or as directed by a physician. Children 2-6 years of age: 1/2 teaspoonful every 4-6 hours or as directed by a physician. Children under 2 years of age: Use as directed by a physician. See package insert for complete prescribing information. PHARMACIST: Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF. This container is not intended for dispensing to the patient. DO NOT USE IF FOIL SEAL IS BROKEN OR MISSING! INDICATIONS AND USAGE: For temporary relief of non-productive cough accompanying respiratory tract congestion associated with the common cold, influenza, sinusitis, and bronchitis. STORAGE: Store at controlled room temperature, 59 o -86 o F (15 o -30 o C). Keep this and all drugs out of the reach of children. In case of accidental overdosage, contact a poison control center and seek professional assistance immediately. Manufactured For: Centurion Labs, LLC. Birmingham, AL 35243 Rev. 07/07 Expectuss Liquid Packaging"],"precautions":["PRECAUTIONS: DRUG INTERACTIONS: Guaifenesin may produce an increase in urinary 5-hydroxy-indoleacetic acid and may therefore interfere with the interpretation of this test for the diagnosis of carcinoid syndrome. It may also falsely elevate the VMA test for catechols. Administration of this drug should be discontinued 48 hours prior to the collection of urine specimens for such tests."],"pregnancy":["PREGNANCY: Pregnancy Category C: Animal reproduction studies have not yet been conducted with this product. It is not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should not be administered to pregnant women."],"set_id":"8bf056bf-7d95-48de-8136-d5a736aedae0","spl_product_data_elements":["EXPECTUSS Liquid Carbetapentane Citrate, and Guaifenesin PENTOXYVERINE CITRATE PENTOXYVERINE Guaifenesin GUAIFENESIN"],"version":"2","warnings":["WARNINGS: A persistent cough may be a sign of a serious condition. If cough persists for more than one week or tends to recur, or is accompanied by fever, rash, or persistent headache, patient reevaluation should be considered."]}