The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Leg Cramp Relief (NDC 57520-0610). 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 INGREDIENTS: Magnesia phosphorica 12X, 30X, Cuprum metallicum 12X, 30X, Colocynthis 12X, 30X, Phytolacca decandra 12X, 30X, Veratrum alum 12X, 30X, Causticum 12X, 30X, Stannum metallicum 12X, 30X, Rhus toxicodendron 12X, 30X.
INDICATIONS: For temporary relief of muscle cramps and spasms most commonly affecting the legs, calves, feet and toes.
WARNINGS: Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
If pregnant or breast-feeding, ask a health professional before use.
Tamper seal: "Sealed for Your Protection." Do not use if seal is broken or missing.
DIRECTIONS: Adults and children 12 years and over dissolve 2 tablets under tongue twice a day. May be increased to 2 tablets 3 times a day, if needed. For children 12 and under, consult a health care professional. For maximum effectiveness, take tablets regularly and consistently. For some, it may take up to 4-6 weeks to achieve maximum results.
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.
INDICATIONS: For temporary relief of muscle cramps and spasms most commonly affecting the legs, calves, feet, and toes.
Dist. by The Magni Group, Inc.
McKinney, TX 75075 USA
www.magnilife.com
800-645-9199
MAGNILIFE
NDC 57520-0610-1
LEG CRAMP RELIEF
Relax Calm Soothe Ease Control
Homeopathic Formula
125 Tablets
Leg Cramp Relief (Mm1)
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