SPL v1
SPL
SPL Set ID 43e0a646-be57-1024-e063-6394a90a43e4
Route
RESPIRATORY (INHALATION)
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Epinephrine,(+/-)- (11.25 mg)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-18
Description

This device is a non-sterile hand-held rubber bulb nebulizer intended to aerosolize bronchodilators for inhalation. This product is listed and approved for over-the-counter use under Monograph M012. This product contains no active or inactive ingredients.

Medication Information

Description

This device is a non-sterile hand-held rubber bulb nebulizer intended to aerosolize bronchodilators for inhalation.

This product is listed and approved for over-the-counter use under Monograph M012.

This product contains no active or inactive ingredients.

Uses

Please consult the use section of the OTC bronchodilator drug label approved for use with this device.

Section 50565-1

Keep out of reach of small children

Section 51727-6

This is the device only and includes no active or inactive ingredients.

Section 51945-4

Section 55105-1

Please consult the purpose section of the OTC bronchodilator drug label approved for use with this device.

Warnings

Please consult the warnings secton for the OTC bronchodilator drug label before use with this device.

Directions
  • Connect bulb to solutions cup.
  • Open top of cup, add approved Bronchodilator, close solutions cup.
  • Squeeze bulb vigorously so visible vapor comes from the top.
  • Breathe in slowly until approved Bronchodilator is gone.
  • Disconnect bulb and follow Cleaning Instructions.
Cleaning Instructions
  • Soak solutions cup in warm, soapy water for 10 minutes.
  • Rinse in warm water.
  • Let air dry.

Structured Label Content

Uses

Please consult the use section of the OTC bronchodilator drug label approved for use with this device.

Section 50565-1 (50565-1)

Keep out of reach of small children

Section 51727-6 (51727-6)

This is the device only and includes no active or inactive ingredients.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Please consult the purpose section of the OTC bronchodilator drug label approved for use with this device.

Warnings

Please consult the warnings secton for the OTC bronchodilator drug label before use with this device.

Directions
  • Connect bulb to solutions cup.
  • Open top of cup, add approved Bronchodilator, close solutions cup.
  • Squeeze bulb vigorously so visible vapor comes from the top.
  • Breathe in slowly until approved Bronchodilator is gone.
  • Disconnect bulb and follow Cleaning Instructions.
Description

This device is a non-sterile hand-held rubber bulb nebulizer intended to aerosolize bronchodilators for inhalation.

This product is listed and approved for over-the-counter use under Monograph M012.

This product contains no active or inactive ingredients.

Cleaning Instructions
  • Soak solutions cup in warm, soapy water for 10 minutes.
  • Rinse in warm water.
  • Let air dry.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:24.185469 · Updated: 2026-03-14T23:10:48.259693