warnings
WARNING Contains dichlorodifluoromethane, dichlorotetrafluoroethane and trichloromonofluoromethane, substances which harm public health and environment by destroying ozone in the upper atmosphere. FOR ORAL INHALATION THERAPY ONLY
FDA label 9d037a99-3e2a-4b69-abfb-9c649cff3956
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- 1bf32957-c996-4718-8927-5ae0afd6174e
- SPL ID
- 9d037a99-3e2a-4b69-abfb-9c649cff3956
- Version
- 4
- Effective date
- 2016-08-02
- Source export date
- 2026-10-12
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:06:38
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 9d037a99-3e2a-4b69-abfb-9c649cff3956 | id | |
| spl set id | 1bf32957-c996-4718-8927-5ae0afd6174e | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings
WARNINGS Do not use this product unless a diagnosis of asthma has been made by a physician. Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland, unless directed by a physician. Do not use this product if you have ever been hospitalized for asthma or if you are taking any prescription drug for asthma unless directed by a physician. MEDIHALER-EPI is intended for oral inhalation only. Do not use this product more frequently or at higher doses than recommended unless directed by a physician. Excessive use may cause nervousness and rapid heartbeat, and, possibly adverse effects on the heart. Do not continue to use this product, but seek medical assistance immediately if symptoms are not relieved within 20 minutes or become worse. As with any drug, if you are pregnant or nursing a baby, seek the advise of a health professional before using this product. Keep this and all drugs out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.