SPL v7
SPL
SPL Set ID 8c2acd62-2f81-4dde-b258-870cd9469f6e
Route
NASAL
Published
Effective Date 2023-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Atropine (5 [hp_X]) Naja Naja Venom (7 [hp_X]) Magnesium Cation Hydroxide Ion
Inactive Ingredients
Aspartic Acid Benzalkonium Chloride Glycerin Propylene Glycol Water Thiamine

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Completed Since 2020-09-23 Until 2026-09-30

Description

Active ingredient                                                                       Purpose Contains atropine (Atropinum) 5X HPUS ………………………………….......  runny nose relief Contains cobra venom preparation (Naja naja) 5X HPUS ……….....  pain relief Contains magnesium chloride (Magnesia muriatica) 5X HPUS…....  cold remedy Contains potassium hydroxide (Kali causticum) 7X HPUS ………. .... flu remedy Reference: the Homeopathic Pharmacopoeia of the United States (HPUS) Contains 24 doses


Medication Information

Description

Active ingredient                                                                       Purpose Contains atropine (Atropinum) 5X HPUS ………………………………….......  runny nose relief Contains cobra venom preparation (Naja naja) 5X HPUS ……….....  pain relief Contains magnesium chloride (Magnesia muriatica) 5X HPUS…....  cold remedy Contains potassium hydroxide (Kali causticum) 7X HPUS ………. .... flu remedy Reference: the Homeopathic Pharmacopoeia of the United States (HPUS) Contains 24 doses

Use

Temporarily relieves symptoms associated with colds and flu.

Section 50565-1

Keep out of reach of children.

Section 55105-1

Warnings

If symptoms persist or worsen, discontinue use, seek medical attention.

• Avoid contact with eyes. If product gets into eyes, flush with water, seek medical attention.

• If pregnant or breastfeeding ask a health professional before use.

• Consult a medical professional if using other medications for known interactions.

• The use of this dispenser by more than one person may spread infection.

Directions
  • Do not use if tamperproof cover is missing.
  • Press down 2-3 times to prime the pump.
  • Spray once into each nostril
  • Use 2 times per day to relieve discomfort.
Product Label

Active Ingredient

Active ingredient                                                                       Purpose

Contains atropine (Atropinum) 5X HPUS ………………………………….......  runny nose relief

Contains cobra venom preparation (Naja naja) 5X HPUS ……….....  pain relief

Contains magnesium chloride (Magnesia muriatica) 5X HPUS…....  cold remedy

Contains potassium hydroxide (Kali causticum) 7X HPUS ………. .... flu remedy

Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Contains 24 doses

Inactive Ingredients

Aspartic acid, benzalkonium chloride, glycerin, propylene glycol, purified water, thiamine.

Comments, Questions or Complaints?

In the U.S. call 833-604-7128, 9:00am - 5:00pm Eastern Standard Time, Monday - Friday, except U.S. holidays or visit www.mdfarma.com available 24 hours.


Structured Label Content

Use

Temporarily relieves symptoms associated with colds and flu.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 55105-1 (55105-1)

Warnings

If symptoms persist or worsen, discontinue use, seek medical attention.

• Avoid contact with eyes. If product gets into eyes, flush with water, seek medical attention.

• If pregnant or breastfeeding ask a health professional before use.

• Consult a medical professional if using other medications for known interactions.

• The use of this dispenser by more than one person may spread infection.

Directions
  • Do not use if tamperproof cover is missing.
  • Press down 2-3 times to prime the pump.
  • Spray once into each nostril
  • Use 2 times per day to relieve discomfort.
Product Label (Product label)

Active Ingredient

Active ingredient                                                                       Purpose

Contains atropine (Atropinum) 5X HPUS ………………………………….......  runny nose relief

Contains cobra venom preparation (Naja naja) 5X HPUS ……….....  pain relief

Contains magnesium chloride (Magnesia muriatica) 5X HPUS…....  cold remedy

Contains potassium hydroxide (Kali causticum) 7X HPUS ………. .... flu remedy

Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Contains 24 doses

Inactive Ingredients (Inactive ingredients)

Aspartic acid, benzalkonium chloride, glycerin, propylene glycol, purified water, thiamine.

Comments, Questions or Complaints?

In the U.S. call 833-604-7128, 9:00am - 5:00pm Eastern Standard Time, Monday - Friday, except U.S. holidays or visit www.mdfarma.com available 24 hours.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)