The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Fibromyalgia Relief (NDC 57520-0582). 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 otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
ACTIVE INGREDIENS: Aconitum napellus 30C, Arsenicum album 30C, Belladonna 30C, Conniinum 30C, Gelsemium sempervirens 30C, Hypericum perforatum 3X, 30C, Kali bichromicum 30C, Lacticum acidum 30C, Phosphoricum acidum 30C, Rhus toxicodendron 30C, Uricum acidum 30C.
USES: Temporarily relieves widespread aches, pains, and stiffness.
WARNINGS: If pregnant or breastfeeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
OTHER INFORMATION: Tamper Sealed: Sealed for your protection. Do not use if seal is broken or missing.
Store tightly closed in a cool, dry place (59-86F).
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United State.
DIRECTIONS: Adults and children 12 years and above: Dissolve 2 tablets under tongue 2 to 3 times daily or as directed by a physician.
Children under 12 years: Consult a physician.
INACTIVE INGREDIENTS: Lactose, Magnesium stearate, Microcrystalline cellulose.
KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.
USES: Temporarily relieves widespread aches, pains, and stiffness.
Dist. by:
The Magni Group, Inc.
McKinney, TX 75071 USA
www.magnilife.com
1-800645-9199
MAGNILIFE
NDC 57520-0582-1
Homeopathic
FIBROMYALGIA RELIEF
For widespread Aches, Pains and Stiffness
125 Tablets
Fibromyalgia Relief (Mm1)
* Please review the disclaimer below.
