Sciatica Formula
FDA Label NDC 76524-321

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Protege' Media Llc for the product Sciatica Formula (NDC 76524-321). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients                                                                                            purpose, indication:, warnings:, directions for use:, other information:, inactive ingredients:, comments, questions or complaints?, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

Indication:

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

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
  • 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:

  • 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

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