Label: RHINOCORT ALLERGY- budesonide spray, metered
- NDC Code(s): 50580-646-01, 50580-646-02, 50580-646-03
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated March 21, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each spray)
- Purpose
- Uses
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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 medicines you take, including this one
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Directions
Read instructions (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 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 months a year.
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
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
RHINOCORT ALLERGY
budesonide spray, meteredProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50580-646 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X) BUDESONIDE 32 ug Inactive Ingredients Ingredient Name Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) EDETATE DISODIUM (UNII: 7FLD91C86K) HYDROCHLORIC ACID (UNII: QTT17582CB) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50580-646-01 1 in 1 CARTON 01/14/2016 10/31/2020 1 60 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:50580-646-02 1 in 1 CARTON 01/14/2016 2 120 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 3 NDC:50580-646-03 3 in 1 PACKAGE 01/14/2016 3 1 in 1 CARTON 3 120 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020746 01/14/2016 Labeler - Johnson & Johnson Consumer Inc. (878046358)