{"active_ingredient":["ACTIVE INGREDIENT (in each immediate-release tablet) Guaifenesin ....................... 400 mg"],"ask_doctor":["Ask a doctor before use if you have Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Cough accompanied by too much phlegm (mucus)"],"dosage_and_administration":["DIRECTIONS Adults and children 12 years of age and over: 1 tablet every 4 hours, not to exceed 6 tablets in 24 hours. Children 6 to under 12 years: 1/2 tablet every 4 hours, not to exceed 3 tablets in 24 hours. This product is not recommended for use in children under 6 years of age. Take with a full glass of water."],"effective_time":"20110323","id":"449bbea2-4e24-4e41-ae1e-5cb0b0617f9c","inactive_ingredient":["INACTIVE INGREDIENTS Croscarmellose Sodium, Hypromellose, Magnesium Stearate, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid."],"indications_and_usage":["USES Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."],"keep_out_of_reach_of_children":["WARNING Keep this and all medications out of the reach of children. In case of accidental overdose seek professional assistance or contact a poison control center immediately."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 100 Tablets Bottle Breckenridge Pharmaceutical, Inc. NDC 51991-606-01 Guaifenesin 400 Tablets Expectorant Each immediate-release tablet contains: Guaifenesin ................... 400 mg 100 TABLETS DO NOT USE IF SAFETY SEAL BAND IS BROKEN OR MISSING FROM THE BOTTLE. Principal Display Panel - 100 Tablets Bottle"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Expectorant"],"questions":["To Report A Serious Adverse Event Contact: (800) 367-3395"],"set_id":"58b888f1-cbb6-43e1-98b3-b6ac319f5847","spl_product_data_elements":["Guaifenesin 400 Guaifenesin Guaifenesin Guaifenesin Croscarmellose Sodium Hypromelloses Magnesium Stearate Maltodextrin Cellulose, Microcrystalline Povidone Silicon Dioxide Stearic Acid Capsule Shaped B;606"],"spl_unclassified_section":["Drug Facts","All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.","Distributed by: Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487 Manufactured by: Provident Pharmaceuticals, LLC Colorado Springs, CO 80919 PL 281 Iss: 04/08"],"stop_use":["Stop use and ask doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness."],"storage_and_handling":["OTHER INFORMATION Tamper-evident: do not use if safety seal band is broken or missing from the bottle. Store at 25° C (77° F ); excursions permitted to 15° – 30°C (59° – 86° F). See USP Controlled Room Temperature."],"version":"2","warnings":["WARNINGS Ask a doctor before use if you have Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Cough accompanied by too much phlegm (mucus) Stop use and ask doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. WARNING Keep this and all medications out of the reach of children. In case of accidental overdose seek professional assistance or contact a poison control center immediately."]}