{"active_ingredient":["Active ingredient (in each extended-release tablet) Guaifenesin 600 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)"],"do_not_use":["Do not use for children under 12 years of age"],"dosage_and_administration":["Directions Use as directed per healthcare professional. do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 or 2 tablets every 12 hours. Do not exceed 4 tablets in 24 hours. children under 12 years of age: do not use"],"effective_time":"20250527","id":"9147ee25-d849-468c-a83d-7b413539c487","inactive_ingredient":["Inactive ingredients Carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate"],"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":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"],"openfda":{"application_number":["ANDA078912"],"brand_name":["Guaifenesin Extended-Release"],"generic_name":["GUAIFENESIN"],"manufacturer_name":["Precision Dose Inc."],"nui":["N0000193956","N0000008867","N0000009560"],"original_packager_product_ndc":["0113-2023"],"package_ndc":["68094-048-59","68094-048-61"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["68094-048"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["636522"],"spl_id":["9147ee25-d849-468c-a83d-7b413539c487"],"spl_set_id":["608b00c5-a2c7-4514-9b46-02954d6675d6"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"],"upc":["0368094048613"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton PrecisionDose™ NDC 68094-048-61 Unit Dose guaiFENesin Extended-Release Tablets, 600 mg 100 Tablets (10 x 10) (in each extended-release tablet) Guaifenesin 600 mg....Expectorant. Directions: do not crush, chew, or break tablet take with a full glass of water Unique Bi-Layer Tablet GLUTEN FREE USUAL DOSE: See Enclosed Drug Facts Store at 20-25°C (68-77°F) Keep out of reach of children. Hospital Use Only. LC1384 R0 Packaged by: Precision Dose, Inc. South Beloit, IL 61080 PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Expectorant"],"questions":["Questions or comments? 1-800-397-9228"],"set_id":"608b00c5-a2c7-4514-9b46-02954d6675d6","spl_product_data_elements":["Guaifenesin Extended-Release Guaifenesin Guaifenesin Guaifenesin CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) FD&C BLUE NO. 1 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE L2X2"],"spl_unclassified_section":["Tablets, 600 mg For Hospital Use Only LI1730 Rev. 10/24","Drug Facts","Gluten Free","How Supplied NDC 68094-048-61 Unit Dose Packages of 100 Tablets (10×10) per Carton","Packaged by: Precision Dose, Inc. South Beloit, IL 61080 For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com LI1730 Rev. 10/24"],"stop_use":["Stop use and ask a 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 store at 20-25°C (68-77°F)"],"version":"3","warnings":["Warnings Do not use for children under 12 years of age 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 a 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. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)"]}