Drug Facts

Manufacturer
Green Earth Health Inc. | Renu Laboratories, Inc.
Effective date
2025-07-23
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:34:31

Label at a glance#

ProductPAIN RELIEF CAFFEINE AND HEMP
Active ingredientCAFFEINE CITRATE, CANNABIS SATIVA SUBSP. SATIVA FLOWERING TOP
Label structure7 sections

Dosage and administration

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)

Label contents#

Full prescribing information#

Active Ingredients                                                                                            Purpose

OTC - ACTIVE INGREDIENT SECTION

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)

Indication:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

• 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:

DOSAGE & ADMINISTRATION SECTION

  • 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)

Other Information:

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73002-321-012025-07-23C16284748780-1c7ccaba7-1182-fd44-e053-dadaa90aa01bDrug Facts
73002-321-012024-01-30C16284748780-1c7ccaba7-1182-fd44-e053-dadaa90aa01bDrug Facts
73002-321-012021-08-24C16284748780-1c7ccaba7-1182-fd44-e053-dadaa90aa01bDrug Facts
73002-321-012021-07-23C16284748780-1c7ccaba7-1182-fd44-e053-dadaa90aa01bDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73002-321-01PAIN RELIEF CAFFEINE AND HEMP28 mL in 1 BOTTLE, SPRAYSPRAY287

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73002-32173002-321-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAIN RELIEF CAFFEINE AND HEMPCAFFEINE (COFFEINUM) 6X, HEMP EXTRACT (CANNABIS SATIVA) 2XGreen Earth Health Inc.ec1b75cd-6627-439d-9f59-6ecd2ac596d12025-07-23WarningsExact identifier
ndc (package): 73002-321-01
ndc (product): 73002-321
ndc11 (package): 73002032101
spl id: 3a98f0c7-ae5b-df15-e063-6294a90ac18a
spl set id: ec1b75cd-6627-439d-9f59-6ecd2ac596d1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.