Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 9dd8b465-8787-42bd-b30a-53cb13a83509
Route
ORAL
Published
Effective Date 2024-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (6 [hp_X]) Naja Naja Venom (4 [hp_X]) Agkistrodon Piscivorus Venom
Inactive Ingredients
Anhydrous Citric Acid Water Sodium Benzoate Sodium Phosphate, Monobasic, Anhydrous Xylitol Vanilla

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2020-09-01 Until 2026-09-30

Description

Caffeine (Coffeinum) 6X (0.0018mg) HPUS                                 Analgesic Cobra venom (Naja naja) 5X (0.07mg) HPUS                              Analgesic Moccasin venom (A.piscivorus) 7X (0.0007mg) HPUS                  Analgesic Approximately 158 sprays per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Purpose

Caffeine (Coffeinum) 6X (0.0018mg) HPUS                                 Analgesic Cobra venom (Naja naja) 5X (0.07mg) HPUS                              Analgesic Moccasin venom (A.piscivorus) 7X (0.0007mg) HPUS                  Analgesic Approximately 158 sprays per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)


Medication Information

Purpose

Caffeine (Coffeinum) 6X (0.0018mg) HPUS                                 Analgesic Cobra venom (Naja naja) 5X (0.07mg) HPUS                              Analgesic Moccasin venom (A.piscivorus) 7X (0.0007mg) HPUS                  Analgesic Approximately 158 sprays per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Description

Caffeine (Coffeinum) 6X (0.0018mg) HPUS                                 Analgesic Cobra venom (Naja naja) 5X (0.07mg) HPUS                              Analgesic Moccasin venom (A.piscivorus) 7X (0.0007mg) HPUS                  Analgesic Approximately 158 sprays per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Warnings:

• Side effects might include headache, nausea, sore throat, allergic rhinitis, gastrointestinal discomfort, itchiness or mild rash.

• Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

• If symptoms persist or worsen, stop using this product and consult physician.

• 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.

Keep out of reach of children.

Indication:

Temporarily relieves pain associated with headache, neck and back pain, menstrual cramps 

Product Label
Directions for Use:
  • Do not use if tamper-proof cover is damaged.
  • Press down 4 times to prime the pump.
  • Spray 2 times directly into the mouth or under the tongue.
  • Start using 3 times per day. Use as needed thereafter to relieve discomfort.
  • Allow several days for product to take maximum effect.
  • Use within 60 days from opening. Store at 50° to 75°F (10°C to 24°C)
Inactive Ingredients:

Citric acid, flavouring, purified water, sodium benzoate, sodium phosphate monobasic, xylitol

Active Ingredients                                                                           purpose

Caffeine (Coffeinum) 6X (0.0018mg) HPUS                                 Analgesic

Cobra venom (Naja naja) 5X (0.07mg) HPUS                              Analgesic

Moccasin venom (A.piscivorus) 7X (0.0007mg) HPUS                  Analgesic

Approximately 158 sprays per container

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


Structured Label Content

Warnings:

• Side effects might include headache, nausea, sore throat, allergic rhinitis, gastrointestinal discomfort, itchiness or mild rash.

• Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

• If symptoms persist or worsen, stop using this product and consult physician.

• 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.

Keep out of reach of children.

Indication:

Temporarily relieves pain associated with headache, neck and back pain, menstrual cramps 

Product Label (Product label)
Directions for Use: (Directions For Use:)
  • Do not use if tamper-proof cover is damaged.
  • Press down 4 times to prime the pump.
  • Spray 2 times directly into the mouth or under the tongue.
  • Start using 3 times per day. Use as needed thereafter to relieve discomfort.
  • Allow several days for product to take maximum effect.
  • Use within 60 days from opening. Store at 50° to 75°F (10°C to 24°C)
Inactive Ingredients:

Citric acid, flavouring, purified water, sodium benzoate, sodium phosphate monobasic, xylitol

Active Ingredients                                                                           purpose (Active Ingredients                                                                           Purpose)

Caffeine (Coffeinum) 6X (0.0018mg) HPUS                                 Analgesic

Cobra venom (Naja naja) 5X (0.07mg) HPUS                              Analgesic

Moccasin venom (A.piscivorus) 7X (0.0007mg) HPUS                  Analgesic

Approximately 158 sprays per container

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


Advanced Ingredient Data


Raw Label Data

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