{"active_ingredient":["OTC - ACTIVE INGREDIENT SECTION For 600 mg: Active ingredient (in each extended-release tablet) Guaifenesin, USP 600 mg For 1200 mg: Active ingredient (in each extended-release tablet) Guaifenesin, USP 1200 mg"],"ask_doctor":["OTC - ASK DOCTOR SECTION 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":["OTC - DO NOT USE SECTION Do not use • for children under 12 years of age"],"dosage_and_administration":["DOSAGE & ADMINISTRATION SECTION Directions For 600 mg • do not crush, chew, or break extended - release 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 extended - release tablets every 12 hours. Do not exceed 4 extended - release tablets in 24 hours. • children under 12 years of age: do not use For 1200 mg • do not crush, chew, or break extended - release 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 extended - release tablet every 12 hours. Do not exceed 2 extended - release tablets in 24 hours. • children under 12 years of age: do not use"],"effective_time":"20251017","id":"0af3bdb4-c1f3-4941-a1de-6e08c49849cb","inactive_ingredient":["INACTIVE INGREDIENT SECTION Inactive ingredients colloidal silicon dioxide, copovidone, FD&C Blue No. 1 Aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid"],"indications_and_usage":["INDICATIONS & USAGE SECTION 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":["OTC - KEEP OUT OF REACH OF CHILDREN SECTION Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["ANDA217780"],"brand_name":["Guaifenesin 1200 mg","Guaifenesin 600 mg"],"generic_name":["GUAIFENESIN 1200 MG","GUAIFENESIN 600 MG"],"is_original_packager":[true],"manufacturer_name":["MARKSANS PHARMA LIMITED"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["25000-042-55","25000-042-01","25000-042-12","25000-042-99","25000-041-75","25000-041-12","25000-041-34"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["25000-041","25000-042"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["310621","636522"],"spl_id":["0af3bdb4-c1f3-4941-a1de-6e08c49849cb"],"spl_set_id":["fedf43d0-d6d1-4f50-bbab-396701e45cb2"],"substance_name":["GUAIFENESIN"],"unii":["495W7451VQ"],"upc":["0325000042127","0325000041120","0325000042554","0325000041342","0325000041755","0325000042011","0325000042998"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC: 25000-042-55 Guaifenesin Extended-Release Tablets 600 mg 20's count (2 x 10's blister) Carton NDC: 25000-042-01 Guaifenesin Extended-Release Tablets 600 mg 20's count Bottle Label NDC: 25000-042-01 Guaifenesin Extended-Release Tablets 600 mg 20's count Bottle Carton NDC: 25000-042-12 Guaifenesin Extended-Release Tablets 600 mg 500's count Bottle Label NDC: 25000-042-99 Guaifenesin Extended-Release Tablets 600 mg 40's count (2 x 20's blister) Carton NDC: 25000-041-75 Guaifenesin Extended-Release Tablets 1200 mg 12's count (2 x 6's blister) Carton NDC: 25000-041-12 Guaifenesin Extended-Release Tablets 1200 mg 500's count Bottle Label NDC: 25000-041-34 Guaifenesin Extended-Release Tablets 1200 mg 28's count (2 x 14's blister) Carton guaifenesin-600mg-blister-ifc20s guaifenesin-600mg-bottle-label-20s guaifenesin-600mg-bottle-ifc-20s guaifenesin-600mg-bottle-label-500s guaifenesin-600mg-blister-ifc-40s guaifenesin-1200mg-12s-blisterifc guaifenesin-1200mg-bottle-label-500s guaifenesin-1200mg-blisters-ifc-28s"],"pregnancy_or_breast_feeding":["OTC - PREGNANCY OR BREAST FEEDING SECTION If pregnant or breast-feeding, ask a health professional before use."],"purpose":["OTC - PURPOSE SECTION Purpose Expectorant"],"questions":["OTC - QUESTIONS SECTION Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM) You may also report side effects to this phone number. Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue, Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate Verna, Goa-403722, India"],"set_id":"fedf43d0-d6d1-4f50-bbab-396701e45cb2","spl_product_data_elements":["Guaifenesin 600 mg Guaifenesin 600 mg GUAIFENESIN GUAIFENESIN SILICON DIOXIDE COPOVIDONE K25-31 HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE 102 POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID FD&C BLUE NO. 1 ALUMINUM LAKE Blue and White 42 Guaifenesin 1200 mg Guaifenesin 1200 mg GUAIFENESIN GUAIFENESIN SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MALTODEXTRIN MICROCRYSTALLINE CELLULOSE 102 POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID FD&C BLUE NO. 1 ALUMINUM LAKE COPOVIDONE K25-31 Blue and White 41"],"stop_use":["OTC - STOP USE SECTION 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":["STORAGE AND HANDLING SECTION Other information • store at 20-25°C (68-77°F)"],"version":"6","warnings":["WARNINGS SECTION"]}