{"active_ingredient":["Active ingredients (in each extended-release tablet) (For 600 mg/60 mg) Guaifenesin USP, 600 mg Pseudoephedrine HCL USP, 60 mg (For 1200 mg/120 mg) Guaifenesin USP, 1200 mg Pseudoephedrine HCL USP, 120 mg"],"ask_doctor":["Ask a doctor before use if you have • 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)"],"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 • adults and children 12 years and older: For 600 mg/60 mg: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours For 1200 mg/120 mg: 1 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours • children under 12 years of age: do not use"],"effective_time":"20251202","id":"44f2a33c-21a2-28a8-e063-6294a90a50ab","inactive_ingredient":["Inactive ingredients carbomer homopolymer Type B, cellulose microcrystalline, hypromellose, lake of FD&C yellow 6, magnesium stearate, sodium starch glycolate Type A"],"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 • 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 Centre right away (1-800 222-1222)."],"openfda":{"application_number":["ANDA216082"],"brand_name":["Guaifenesin and Pseudoephedrine HCl"],"generic_name":["GUAIFENESIN AND PSEUDOEPHEDRINE HCL"],"is_original_packager":[true],"manufacturer_name":["Granules India Ltd"],"nui":["N0000193956","N0000008867","N0000009560"],"package_ndc":["62207-827-72","62207-828-71"],"pharm_class_epc":["Expectorant [EPC]"],"pharm_class_pe":["Decreased Respiratory Secretion Viscosity [PE]","Increased Respiratory Secretions [PE]"],"product_ndc":["62207-827","62207-828"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1244675","1305603"],"spl_id":["44f2a33c-21a2-28a8-e063-6294a90a50ab"],"spl_set_id":["75f4ff44-02e7-4a23-a394-85fe8b442e1a"],"substance_name":["GUAIFENESIN","PSEUDOEPHEDRINE HYDROCHLORIDE"],"unii":["6V9V2RYJ8N","495W7451VQ"],"upc":["0362207828710","0362207827720"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL 600 mg and 60 mg - Blister Foil Label ggf-pseudo-600mg-60mg-foil-label","PRINCIPAL DISPLAY PANEL 600 mg and 60 mg - Blister Carton Label NDC 62207-827-72 † Compare To the active ingredients of Mucinex ® D Guaifenesin and Pseudoephedrine Hydrochloride FOR DAY OR NIGHT Extended-Release Tablets 12HR 600 mg and 60 mg Guaifenesin 600 mg - Expectorant • Clears Nasal & Sinus Congestion Pseudoephedrine HCl 60 mg - Nasal Decongestant • Thins & Loosens Mucus • Immediate & Extended Release RELIEVES NASAL & CHEST CONGESTION 90 (9x10) Extended-Release Tablets ggf-pseudo-600mg-60mg-blistercarton","PRINCIPAL DISPLAY PANEL 1200 mg and 120 mg - Blister Foil Label ggf-pseudo-1200mg-120mg-foil-label","PRINCIPAL DISPLAY PANEL 1200 mg and 120 mg - Blister Carton Label NDC 62207-828-71 † Compare To the active ingredients of Mucinex ® D Guaifenesin and Pseudoephedrine Hydrochloride FOR DAY OR NIGHT Extended-Release Tablets 12HR 1200 mg and 120 mg Guaifenesin 1200 mg - Expectorant • Clears Nasal & Sinus Congestion Pseudoephedrine HCl 120 mg - Nasal Decongestant • Thins & Loosens Mucus • Immediate & Extended Release RELIEVES NASAL & CHEST CONGESTION 70 (7x10) Extended-Release Tablets ggf-pseudo-1200mg-120mg-blistercarton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purposes Expectorant Nasal Decongestant"],"questions":["Questions or comments? Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST. You may also report side effects to this phone number. Keep the carton. It contains important information. See end panel for expiration date. Manufactured By: Granules India Limited Hyderabad – 500 081, INDIA MADE IN INDIA Distributed By: Granules USA, Inc. Parsippany, NJ 07054"],"set_id":"75f4ff44-02e7-4a23-a394-85fe8b442e1a","spl_product_data_elements":["Guaifenesin and Pseudoephedrine HCl Guaifenesin and Pseudoephedrine HCl MAGNESIUM STEARATE FD&C YELLOW NO. 6 CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A HYPROMELLOSE 2910 (5 MPA.S) HYPROMELLOSE 2910 (10000 MPA.S) GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE Light orange and orange colored GP;600 Guaifenesin and Pseudoephedrine HCl Guaifenesin and Pseudoephedrine HCl MAGNESIUM STEARATE FD&C YELLOW NO. 6 CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) CELLULOSE, MICROCRYSTALLINE SODIUM STARCH GLYCOLATE TYPE A HYPROMELLOSE 2910 (5 MPA.S) HYPROMELLOSE 2910 (10000 MPA.S) GUAIFENESIN GUAIFENESIN PSEUDOEPHEDRINE HYDROCHLORIDE PSEUDOEPHEDRINE Light orange and orange colored GP;1200"],"stop_use":["Stop use and ask a 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."],"version":"4","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 you have • 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 a 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. 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 Centre right away (1-800 222-1222).","Other information • Tamper evident: do not use if carton is open or if printed seal on blister is broken or missing. • store between 20-25°C (68-77°F)"],"when_using":["When using this product • do not use more than directed"]}