PAIN RELIEF CAFFEINE AND HEMP (caffeine (coffeinum) 6x, hemp extract- cannabis sativa 2x liquid

PAIN RELIEF CAFFEINE AND HEMP by

Drug Labeling and Warnings

PAIN RELIEF CAFFEINE AND HEMP by is a Homeopathic medication manufactured, distributed, or labeled by Green Earth Health Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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)

PURPOSE

Indication:

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

KEEP OUT OF REACH OF CHILDREN

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.

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).

Other Information:

• Consult a medical professional if using other medications for known interactions.
• Cannabidiol in hemp extract may alter the metabolism of other drugs.

Inactive Ingredients:

Citric acid, flavoring, glycerin, potassium sorbate, purified water, sodium benzoate, vitamin C, xanthan gum

Product label

INGREDIENTS AND APPEARANCE

PAIN RELIEF CAFFEINE AND HEMP 
caffeine (coffeinum) 6x, hemp extract (cannabis sativa) 2x liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73002-351
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAFFEINE CITRATE (UNII: U26EO4675Q) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE CITRATE	6 [hp_X]  in 1 mL
CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP (UNII: 8X454SZ22D) (CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP - UNII:8X454SZ22D)	CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP	2 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)
TEA LEAF (UNII: GH42T47V24)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73002-351-01	28 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	09/01/2020	09/30/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/01/2020	09/30/2026

Labeler - Green Earth Health Inc. (116983264)

Registrant - Green Earth Health Inc. (116983264)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, Inc.		945739449	manufacture(73002-351)