{"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 POLY HIST CB 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: POLY HIST CB is contraindicated in infants and newborns, and in patients with a known hypersensitivity to any of the components. It is also contraindicated in patients on MAO inhibitor therapy."],"description":["POLY HIST CB Antitussive/Expectorant Rx Only Description: POLY HIST CB 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 POLY HIST CB Liquid also contains: FD and C Blue #1, FD and C Red #40, Grape Flavor, Maltitol, Propylene Glycol, Sodium Saccharin, Sorbitol, Purified Water."],"dosage_and_administration":["Dosage and Administration: POLY HIST CB 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 2-6 years of age: 1/2 teaspoonful every 4-6 hours or as directed by a physician. Children under 2 years of age: As directed by a physician."],"effective_time":"20170918","how_supplied":["How Supplied: 16 fluid ounce bottles NDC # 50991-781-16 and 15 mL bottles NDC # 50991-781-15 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. Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. Store at controlled room temperature, 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: Poly Pharmaceuticals Mobile, AL 36619 Rx Only Rev. 11/09"],"id":"597cc41c-75d8-cc31-e053-2a91aa0a3846","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 50991-781-16 Poly Hist CB Grape Flavor Sugar Free Alcohol Free Antitussive/Expectorant Each 5 mL (1 teaspoonful) contains: Carbetapentane Citrate..... 20 mg Guaifenesin...................... 75 mg Distributed by: Poly Pharmaceuticals Mobile, AL 36619 Rx Only 16 fl oz (473 mL) Side Panel: USUAL DOSAGE: Adults 12 years and older: 1-2 teaspoonfuls every 4-6 hours. Children 6-12 years of age: 1 teaspoonful every 4-6 hours. Children 2-6 years of age: 1/2 teaspoonful every 4-6 hours. Children under 2 years of age: As directed by a physician. See package insert for complete prescribing information. 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. Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. This bottle is not to be dispensed to consumer. STORAGE: Store at controlled room temperature, 59 o -86 o F (15 o -30 o C). Mfg. for: Poly Pharmaceuticals, Mobile, AL 36619 Mfg. by: Great Southern Laboratories. Houston, TX 77099 Rev. 11/09 Poly Hist CB Packaging Poly Hist CB 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":"c3a1a47a-27ce-4565-9d6a-a2d8314357a6","spl_product_data_elements":["Poly Hist CB Carbetapentane Citrate, and Guaifenesin GUAIFENESIN GUAIFENESIN PENTOXYVERINE CITRATE PENTOXYVERINE"],"version":"3","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."]}