{"active_ingredient":["Active ingredient Oxymetazoline HCl 0.05%"],"ask_doctor":["Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland"],"dosage_and_administration":["Directions adults and children 6 to under 12 years of age (with adult supervision): 2 or 3 sprays in each nostrill. Not more often than every 10 to 12 hours. Do not exceed 2 doses in any 24-hour period. children under 6 years of age: ask a doctor. Shake well before use. To open, rotate cap to align the marks. Squeeze cap on both sides in a counter-clockwise turn and pull off to remove. To spray, hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress with a firm, even stroke and sniff deeply. Wipe nozzle clean after use and snap cap back onto the bottle."],"effective_time":"20251009","id":"40b8f0e4-90a0-f6b2-e063-6394a90a083b","inactive_ingredient":["Inactive Ingredients benzalkonium chloride, dibasic sodium phosphate, edetate disodium dihydrate, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, povidone, purified water."],"indications_and_usage":["Uses temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily relive sinus congestion and pressure shrinks swollen nasal membrances so you can breathe more freely"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"openfda":{"application_number":["M012"],"brand_name":["Giltuss Severe Sinus"],"generic_name":["OXYMETAZOLINE HCL"],"is_original_packager":[true],"manufacturer_name":["Gil Pharmaceutical Corp"],"package_ndc":["58552-142-15"],"product_ndc":["58552-142"],"product_type":["HUMAN OTC DRUG"],"route":["NASAL"],"rxcui":["1000990"],"spl_id":["40b8f0e4-90a0-f6b2-e063-6394a90a083b"],"spl_set_id":["ab7fae3b-1f7d-5d0f-e053-2a95a90a148e"],"substance_name":["OXYMETAZOLINE HYDROCHLORIDE"],"unii":["K89MJ0S5VY"]},"package_label_principal_display_panel":["FAST AND POWERFUL Giltuss® SEVERE SINUS UP TO 12 HOURS RELIEF EXTRA MOISTURIZING FAST RELIEF OF: SINUS CONGESTION AND PRESSURE STUFFY NOSE PUMP MIST 0.5 FL OZ (15 mL) Severe Sinus 6-25-2020"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nasal decongestant"],"set_id":"ab7fae3b-1f7d-5d0f-e053-2a95a90a148e","spl_product_data_elements":["Giltuss Severe Sinus Oxymetazoline HCl GLYCERIN BENZALKONIUM CHLORIDE EDETATE DISODIUM POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL WATER SODIUM PHOSPHATE, MONOBASIC SODIUM PHOSPHATE, DIBASIC OXYMETAZOLINE HYDROCHLORIDE OXYMETAZOLINE"],"spl_unclassified_section":["Drug Facts","Tamper evident: do not use if safety seal is broken or missing MANUFACTURED FOR GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00717-1565 giltuss.com"],"stop_use":["Stop use and ask a doctor if symptoms persist"],"storage_and_handling":["Other information store between 20° to 25°C (68° to 77° F) retain carton for future reference on full labeling"],"version":"6","warnings":["Warnings Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland When using this product do not use more than directed do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur use of this container by more than one person may spread infection Stop use and ask a doctor if symptoms persist If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product do not use more than directed do not use for more than 3 days. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen. temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur use of this container by more than one person may spread infection"]}