Active Ingredient (In Each Spray)
Budesonide (glucocorticoid) 32 mcg
The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Budesonide (NDC 0536-1456). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each spray), purpose, uses, do not use, ask a doctor before use if you, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Budesonide (glucocorticoid) 32 mcg
Nasal allergy symptom reliever
Temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Read insert (inside package) on how to:
| ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER | |
| adults and children 12 years of age and older |
|
| 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 |
|
| children under 6 years of age |
|
carboxymethyl cellulose sodium, dextrose anhydrous, edetate disodium dihydrate, hydrochloric acid (for pH adjustment), microcrystalline cellulose, polysorbate 80, potassium sorbate, purified water
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budesonide
nasal spray
budesonide (glucocorticoid)
32 mcg per spray
nasal allergy
symptom reliever
original prescription strength
24-hours relief of:
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
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