SPL v1
SPL
SPL Set ID 36a428a9-4549-bbd4-e063-6294a90ae783
Route
NASAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ammonia (29 g)
Inactive Ingredients
Peppermint Oil Sodium Polyacrylate (8000 Mw)

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-04-01
Description

Aqueous ammonia (29%)

Medication Information

Warnings and Precautions
  • Temporary burning, stinging or eye watering may occur.
  • For external use only. Flammable: keep away from fire or flame.
  • Do not use if allergic to any of the ingredients.
  • Not recommended for use to revive people after injuries to the head or brain.
  • This product has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease
Indications and Usage

Respitory stimulant. For inhalation only. Use responsibly and in moderation.

Best used within 30 days after opening. Store in a cool, dry place

Dosage and Administration
  • Hold 2-3 inches below nose
  • Squeeze & inhale
Description

Aqueous ammonia (29%)

Section 50565-1

Keep out of reach of small children.

Section 51727-6

Peppermint essential oil, sodium polyacrylate

Section 51945-4

Section 53414-9

If pregnant, breastfeeding or at risk of any underlying respiratory conditions, ask a healthcare professional before use.

Section 55105-1

Reflex stimulant

Section 55106-9

Aqueous ammonia (29%)

Structured Label Content

Indications and Usage (34067-9)

Respitory stimulant. For inhalation only. Use responsibly and in moderation.

Best used within 30 days after opening. Store in a cool, dry place

Dosage and Administration (34068-7)
  • Hold 2-3 inches below nose
  • Squeeze & inhale
Warnings and Precautions (34071-1)
  • Temporary burning, stinging or eye watering may occur.
  • For external use only. Flammable: keep away from fire or flame.
  • Do not use if allergic to any of the ingredients.
  • Not recommended for use to revive people after injuries to the head or brain.
  • This product has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease
Section 50565-1 (50565-1)

Keep out of reach of small children.

Section 51727-6 (51727-6)

Peppermint essential oil, sodium polyacrylate

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant, breastfeeding or at risk of any underlying respiratory conditions, ask a healthcare professional before use.

Section 55105-1 (55105-1)

Reflex stimulant

Section 55106-9 (55106-9)

Aqueous ammonia (29%)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:14.276705 · Updated: 2026-03-14T23:08:54.445441