{"active_ingredient":["Active ingredient(s) Guaifenesin USP, 600 mg................................................................................Expectorant Pseudoephedrine HCl USP, 60 mg......................................................Nasal Decongestant Guaifenesin USP, 1200 mg................................................................................Expectorant Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant"],"ask_doctor":["Ask a doctor before use if ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ 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 if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."],"dosage_and_administration":["Directions ■ do not crush, chew, or break extended-release tablet ■ take with a full glass of water ■ this product can be administered without regard for timing of meals ■ children under 12 years of age: do not use For 600 mg/60 mg ■ adults and children 12 years and older: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours For 1200 mg/120 mg ■ adults and children 12 years and older: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours"],"effective_time":"20251024","id":"9e158de3-9d7a-e6f8-2e19-5ef46d33e8cd","inactive_ingredient":["Inactive ingredients FD & C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide."],"indications_and_usage":["Use(s) ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bother some mucus and make coughs more productive ■ temporarily relieves nasal congestion due to: ■ common cold ■ hay fever ■ upper respiratory allergies ■ temporarily restores freer breathing through the nose ■ promotes nasal and/or sinus drainage ■ temporarily relieves sinus congestion and pressure"],"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":["ANDA208369"],"brand_name":["Guaifenesin and Pseudoephedrine HCL"],"generic_name":["GUAIFENESIN AND PSEUDOEPHEDRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Dr. Reddys Laboratories Limited"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["55111-798-09","55111-798-18","55111-798-36","55111-798-35","55111-798-41","55111-799-12","55111-799-24","55111-799-36","55111-799-06","55111-799-04"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["55111-798","55111-799"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1244675","1305603"],"spl_id":["9e158de3-9d7a-e6f8-2e19-5ef46d33e8cd"],"spl_set_id":["845a2dcc-9069-3141-ae13-f2063f36d130"],"substance_name":["GUAIFENESIN","PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["6V9V2RYJ8N","495W7451VQ"]},"package_label_principal_display_panel":["Principal Display Panel Guaifenesin and Pseudoephedrine HCl ER Tablets 600 mg/60 mg: 18s (1x18s)","Guaifenesin and Pseudoephedrine HCl ER Tablets 1200 mg/120 mg: 24s (2x12s)"],"pregnancy_or_breast_feeding":["Pregnancy/Breastfeeding ask a health professional before use."],"purpose":["Purpose Expectorant and Nasal Decongestant"],"questions":["Questions call 1-888-375-3784 You may also report side effect to this phone number. Keep the carton. It contains important information. See end panel for expiration date. DISTRIBUTED BY: Dr. Reddy’s Laboratories Inc., Princeton, NJ – 08540 Made in India"],"set_id":"845a2dcc-9069-3141-ae13-f2063f36d130","spl_product_data_elements":["Guaifenesin and Pseudoephedrine HCL Guaifenesin and Pseudoephedrine HCL Guaifenesin Guaifenesin Pseudoephedrine Hydrochloride Pseudoephedrine FD&C YELLOW NO. 6 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE SILICON DIOXIDE RDY;798 Guaifenesin and Pseudoephedrine HCL Guaifenesin and Pseudoephedrine HCL Guaifenesin Guaifenesin Pseudoephedrine Hydrochloride Pseudoephedrine FD&C YELLOW NO. 6 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE SILICON DIOXIDE RDY;799 carton1 carton2"],"spl_unclassified_section":["Other information ■ tamper evident: do not use if carton is open or if printed seal on blister is broken or missing."],"stop_use":["Stop use and ask doctor if ■ you get nervous, dizzy, or sleepless ■ symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness."],"storage_and_handling":["Storage ■ store between 20°-25°C (68°-77°F)"],"version":"9","warnings":["Warnings Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ■ cough accompanied by too much phlegm (mucus) When using this product ■ do not use more than directed Stop use and ask doctor if ■ you get nervous, dizzy, or sleepless ■ symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness. Pregnancy/Breastfeeding 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)."],"when_using":["When using this product ■ do not use more than directed"]}