Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 540d8310-72a6-45a5-a028-240698d1f637
Route
ORAL
Published
Effective Date 2023-12-26
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 2020-09-01 Until 2026-09-30

Description

Active Ingredients per dose:                                                                                                    Purpose Caffeine (Coffeinum) 6X (0.0027mg) HPUS                                                                                  Analgesic Hemp extract (Cannabis sativa) 2X (16.95 mg) HPUS                                                                   Anti-inflammatory Approximately 56 doses per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)


Medication Information

Description

Active Ingredients per dose:                                                                                                    Purpose Caffeine (Coffeinum) 6X (0.0027mg) HPUS                                                                                  Analgesic Hemp extract (Cannabis sativa) 2X (16.95 mg) HPUS                                                                   Anti-inflammatory Approximately 56 doses per container Reference: the Homeopathic Pharmacopoeia of the United States (HPUS)

Section 55106-9

Active Ingredients per dose:                                                                                                    Purpose

Caffeine (Coffeinum) 6X (0.0027mg) HPUS                                                                                  Analgesic

Hemp extract (Cannabis sativa) 2X (16.95 mg) HPUS                                                                   Anti-inflammatory

Approximately 56 doses 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.
  • Use graduated dropper and take 0.5ml of liquid.
  • Put the liquid directly in to the mouth or under the tongue.
  • Start using twice per day. Use as needed thereafter to relieve discomfort.
  • Allow several days for product to take maximum effect.
  • Use within 60 days of 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


Structured Label Content

Section 55106-9 (55106-9)

Active Ingredients per dose:                                                                                                    Purpose

Caffeine (Coffeinum) 6X (0.0027mg) HPUS                                                                                  Analgesic

Hemp extract (Cannabis sativa) 2X (16.95 mg) HPUS                                                                   Anti-inflammatory

Approximately 56 doses 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 (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.
  • Use graduated dropper and take 0.5ml of liquid.
  • Put the liquid directly in to the mouth or under the tongue.
  • Start using twice per day. Use as needed thereafter to relieve discomfort.
  • Allow several days for product to take maximum effect.
  • Use within 60 days of 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


Advanced Ingredient Data


Raw Label Data

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