Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID ec1b75cd-6627-439d-9f59-6ecd2ac596d1
Route
ORAL
Published
Effective Date 2021-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Caffeine (6 [hp_X]) Cannabis Sativa Subsp. Sativa Flowering Top (2 [hp_X])
Inactive Ingredients
Anhydrous Citric Acid Glycerin Siraitia Grosvenorii Fruit Tea Leaf Potassium Sorbate Water Sodium Benzoate Ascorbic Acid Xanthan Gum

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2019-12-19 Until 2026-09-30

Description

Caffeine (Coffeinum) 6X (0.0018mg) HPUS                                                 Analgesic Hemp extract (Cannabis sativa) 2X (11.3 mg) HPUS                                    Anti-inflammatory Approximately 158 sprays per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Purpose

Caffeine (Coffeinum) 6X (0.0018mg) HPUS                                                 Analgesic Hemp extract (Cannabis sativa) 2X (11.3 mg) HPUS                                    Anti-inflammatory Approximately 158 sprays per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)


Medication Information

Purpose

Caffeine (Coffeinum) 6X (0.0018mg) HPUS                                                 Analgesic Hemp extract (Cannabis sativa) 2X (11.3 mg) HPUS                                    Anti-inflammatory Approximately 158 sprays per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Description

Caffeine (Coffeinum) 6X (0.0018mg) HPUS                                                 Analgesic Hemp extract (Cannabis sativa) 2X (11.3 mg) HPUS                                    Anti-inflammatory Approximately 158 sprays per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Warnings:

• 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 or if diagnosed with psychiatric or mood disorder, seek medical advice before use.

• Keep out of reach of children.

Indication:

Temporarily relieves pain associated with sciatica, lower back pain and cystitis

Product Label

Other Information:
  • Consult a medical professional if using other medications for known interactions.
  • Cannabidiol in hemp extract may alter the metabolism of other drugs.
Directions for Use:
  • Do not use if tamperproof cover is missing
  • 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, flavoring, glycerin, potassium sorbate, purified water, sodium benzoate, vitamin C, xanthan gum

Active Ingredients                                                                                            Purpose

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

Hemp extract (Cannabis sativa) 2X (11.3 mg) HPUS                                    Anti-inflammatory

Approximately 158 sprays per container

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


Structured Label Content

Warnings:

• 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 or if diagnosed with psychiatric or mood disorder, seek medical advice before use.

• Keep out of reach of children.

Indication:

Temporarily relieves pain associated with sciatica, lower back pain and cystitis

Product Label (Product label)

Other Information:
  • Consult a medical professional if using other medications for known interactions.
  • Cannabidiol in hemp extract may alter the metabolism of other drugs.
Directions for Use: (Directions For Use:)
  • Do not use if tamperproof cover is missing
  • 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, flavoring, glycerin, potassium sorbate, purified water, sodium benzoate, vitamin C, xanthan gum

Active Ingredients                                                                                            Purpose

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

Hemp extract (Cannabis sativa) 2X (11.3 mg) HPUS                                    Anti-inflammatory

Approximately 158 sprays per container

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)