Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a25ead25-98d9-47d8-893a-caf29b3e2581
Route
ORAL
Published
Effective Date 2020-10-28
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 Active Since 2020-10-28

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

Comments, Questions Or Complaints?

Call 888-735-4009 or [email protected]

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

Comments, Questions Or Complaints? (Comments, Questions or Complaints?)

Call 888-735-4009 or [email protected]

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

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