Temporary Fibromyalgia Pain And Discomfort Relief
FDA Label NDC 17312-004

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Trp Company for the product Temporary Fibromyalgia Pain And Discomfort Relief (NDC 17312-004). 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 homeopathic purpose, active ingredients, inactive ingredients, uses, warnings, otc - keep out of reach of children, do not use, stop use and see a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Homeopathic Purpose

Aconitum Napellus6c/12c/18cAcute Pain, Inflammation
Belladonna6c/12c/18cChronic Pain, Headache
Causticum6c/12c/18cMuscle and Nerve Pain
Magnesium Phos6c/12c/18cCramping Pain, Fatigue
Nux Vomica6c/12c/18cSleeplessness, Irritable bowels
Rhus Toxicodendron6c/12c/18cJoint and Soft Tissue Pain

Active Ingredients

Aconitum Napellus6c/12c/18c
Belladonna6c/12c/18c
Causticum6c/12c/18c
Magnesium Phos6c/12c/18c
Nux Vomica6c/12c/18c
Rhus Toxicodendron6c/12c/18c
Magnesium Ascorbate200 mg
Thiamine Hydrochloride1 mg
Riboflavin1 mg
Niacinamide20 mg
Pyridoxine Hydrochloride1 mg
Folic Acid400 mcg
Cyanocobalamin400 mcg
Biotin200 mcg
Calcium Pantothenate5 mg
Magnesium Ascorbate75 mg
Magnesium Oxide75 mg
Selenium100 mcg
Sedum Roseum Root200 mg

Inactive Ingredients

Microcrystalline cellulose
Polyvinyl Alcohol
Talc
Macrogol/PEG 3350
Polysorbate 80
Sodium Carboxymethylcellulose
Dextrin
Dextrose Monohydrate
Lecithin
Sodium Citrate
Stearic Acid
Croscarmellose
Magnesium Stearate
Silicon Dioxide
Sucralose

Uses

According to homeopathic indications these ingredients provide temporary relief from symptoms of Fibromyalgia such as:

- Muscle Pain
- Fatigue
- Nerve/Soft Tissue Pain
- Headache
- Multiple Tender Points

Warnings

- Consult with your doctor prior to use if you are pregnant or nursing.
- Initial worsening of symptoms may occur.
- If symptoms persist or worsen, consult your doctor.
- Anyone experiencing widespread pain as with Fibromyalgia should see a doctor to determine if a specific treatment is needed or to make sure that it is not a sign of a serious underlying condition.

Otc - Keep Out Of Reach Of Children

Keep this and all medicines out of reach of children.

Do Not Use

If tamper evident seal is broken.

Stop Use And See A Doctor If

If Symptoms persist for more than 7 days or worsen or if new symptoms occur or if redness or swelling is present because these could be a sign of a serious illness.

Directions

Take 1 caplet, morning and evening, 5 minutes before or 20 minutes after a meal. Let the homeopathic external shell dissolve in your mouth until the sweetness is gone (approx. 20-40 seconds), then swallow the remaining vitamin enriched core with water. For faster results take 1 caplet 3 times per day. For best results, use for at least 6 months. After desired results are achieved, reduce dosing to 1 caplet 2 times per day.

Other Information

If an initial worsening (healing aggravation) of symptoms occurs stop use until the aggravations subsides, then continue taking the caplets.

Otc - Questions

TRP Company
1575 Delucchi Lane #115
Reno, NV 89502
888-969-6855
www.trpcompany.com

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