{"active_ingredient":["Active ingredient (in each spray) Budesonide (glucocorticoid) 32 mcg"],"ask_doctor":["Ask a doctor before use if you have had recent nose ulcers or nose surgery have had a nose injury that has not healed are using a steroid medicine for asthma, allergies or skin rash have an eye infection have or had glaucoma or cataracts"],"do_not_use":["Do not use in children under 6 years of age if you have ever had an allergic reaction to any of the ingredients"],"dosage_and_administration":["Direction Read insert (inside package) on how to: get a new bottle ready (primed) before first use prime bottle again if not used for two days use the spray clean the spray nozzle ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER adults and children 12 years of age and older once daily, spray 2 times into each nostril while sniffing gently once your allergy symptoms improve, reduce to 1 spray in each nostril per day CHILDREN 6 YEARS TO UNDER 12 YEARS OF AGE • the growth rate of some children may be slower while using this product. Talk to your child's doctor if your child needs to use the spray for longer than two month children 6 to under 12 years of age an adult should supervise use once daily, spray 1 time into each nostril while sniffing gently if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day children under 6 years of age do not use do not use more than directed if you forget a dose, do not double the next dose do not spray into eyes or mouth if allergy symptoms do not improve after two weeks, stop using and talk to a doctor do not use for the common cold shake well before each use"],"dosage_and_administration_table":["
ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER
adults and children 12 years of age and older once daily, spray 2 times into each nostril while sniffing gentlyonce your allergy symptoms improve, reduce to 1 spray in each nostril per day
","
CHILDREN 6 YEARS TO UNDER 12 YEARS OF AGE
","
children 6 to under 12 years of agean adult should supervise useonce daily, spray 1 time into each nostril while sniffing gentlyif allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day
","
children under 6 years of agedo not use
"],"effective_time":"20251209","id":"5592d8c7-a130-4ec6-8b15-9329daeb91c7","inactive_ingredient":["Inactive ingredients carboxymethyl cellulose sodium, dextrose anhydrous, edetate disodium dihydrate, hydrochloric acid (for pH adjustment), microcrystalline cellulose, polysorbate 80, potassium sorbate, purified water"],"indications_and_usage":["Use s Temporarily relieves these symptoms of hay fever or other upper respiratory allergies: nasal congestion runny nose sneezing itchy nose"],"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 (1-800-222-1222) right away."],"openfda":{"application_number":["ANDA078949"],"brand_name":["Budesonide"],"generic_name":["BUDESONIDE"],"is_original_packager":[true],"manufacturer_name":["Rugby Laboratories"],"nui":["N0000175576","N0000175450"],"package_ndc":["0536-1456-84"],"pharm_class_epc":["Corticosteroid [EPC]"],"pharm_class_moa":["Corticosteroid Hormone Receptor Agonists [MoA]"],"product_ndc":["0536-1456"],"product_type":["HUMAN OTC DRUG"],"route":["NASAL"],"rxcui":["1797929"],"spl_id":["5592d8c7-a130-4ec6-8b15-9329daeb91c7"],"spl_set_id":["b83af99e-1619-48ed-a033-e5207033f77e"],"substance_name":["BUDESONIDE"],"unii":["Q3OKS62Q6X"]},"package_label_principal_display_panel":["Principal Display Panel budesonide nasal spray budesonide (glucocorticoid) 32 mcg per spray nasal allergy symptom reliever original prescription strength 24-hours relief of: nasal congestion runny nose itchy nose sneezing non-drowsy ↑ store upright ↑ metered sprays fl oz (mL) IMPORTANT: Read all product information before using. Keep package and insert. They contain important information TAMPER EVIDENT: DO NOT USE IF CARTON SEALS ARE BROKEN. Distributed by: RUGBY® LABORATORIES Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Product of Italy","Package label RUGBY Nasal Spray Nasal Spray Budesonide 32 mcg Budesonide"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Nasal allergy symptom reliever"],"questions":["Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"],"set_id":"b83af99e-1619-48ed-a033-e5207033f77e","spl_product_data_elements":["Budesonide Budesonide BUDESONIDE Budesonide EDETATE DISODIUM CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED MICROCRYSTALLINE CELLULOSE DEXTROSE, UNSPECIFIED FORM POTASSIUM SORBATE POLYSORBATE 80 HYDROCHLORIC ACID WATER"],"spl_unclassified_section":["Other information do not use if carton seals are broken keep the package and insert. They contain important information. store upright 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light."],"stop_use":["Stop use and ask a doctor if you have, or come into contact with someone who has, chickenpox, measles or tuberculosis you have or develop symptoms of an infection such as persistent fever you have any change in vision you have severe or frequent nosebleeds"],"version":"2","warnings":["Warnings Do not use in children under 6 years of age if you have ever had an allergic reaction to any of the ingredients Ask a doctor before use if you have had recent nose ulcers or nose surgery have had a nose injury that has not healed are using a steroid medicine for asthma, allergies or skin rash have an eye infection have or had glaucoma or cataracts When using this product the growth rate of some children may be slower some symptoms may get better on the first day of treatment. It may take up to two weeks of daily use to feel the most symptom relief. do not share this bottle with anyone else as this may spread germs remember to tell your doctor about all the medicines you take, including this one Stop use and ask a doctor if you have, or come into contact with someone who has, chickenpox, measles or tuberculosis you have or develop symptoms of an infection such as persistent fever you have any change in vision you have severe or frequent nosebleeds 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 (1-800-222-1222) right away."],"when_using":["When using this product the growth rate of some children may be slower some symptoms may get better on the first day of treatment. It may take up to two weeks of daily use to feel the most symptom relief. do not share this bottle with anyone else as this may spread germs remember to tell your doctor about all the medicines you take, including this one"]}