Leg Cramps Tablet
FDA Label NDC 70163-0005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Naturalcare for the product Leg Cramps (NDC 70163-0005). 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 ingredient:, purpose:, uses:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient:

(in each tablet) Calcarea Carbonica 6X, 12X, 30X 0.0083%, Chininum Sulphuricum 4X 0.0083%, Colocynthis 4X 0.0083%, Cuprum Metallicum 12X 0.0083%, Gnaphalium Polycephalum 4X 0.0083%, Lycopodium Clavatum 6X 0.0083%, Magnesia Phosphorica 6X 0.0083%, Rhus Tox 6X, 12X, 30X 0.0083%.

Purpose:

Calcarea Carbonica – cramps in calves at night, Chininum Sulphuricum – neuralgia, tearing leg pains, Colocynthis – contraction of muscles, leg cramps, Cuprum Metallicum – cramps in legs and feet, Gnaphalium Polycephalum – frequent cramps in legs, Lycopodium Clavatum – cramps in calves, sciatica, Magnesia Phosphorica – severe cramps in calves, Rhus Tox – cramps in calves*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Uses:

May help temporarily relieve* ■ muscle pains & spasms

■ cramps in calves & feet ■ night cramps & pain

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

Stop and ask a doctor if

■ symptoms worsen or persist for more than 7 days

■ new symptoms appear

■ redness or swelling are present

If pregnant or breast-feeding, 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.

Do not use if printed foil blister is broken or missing.

■ Store at room temperature (65-80°F)

Keep Out Of Reach Of Children:

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Adults and children 12 years and over:

■ take 2 tablets every 2 hours for 2 doses, then reduce to 1 tablet every 4 hours

Inactive Ingredients:

croscarmellose sodium, dextrose, lactose, magnesium stearate, microcrystalline cellulose

Questions:

Dist. By NaturalCare

201 Apple Blvd.

Woodbine, IA 51579

www.NaturalCareWorks.com

1-888-280-5672

Package Label Display:

NaturalCare

Leg Cramps

Homeopathic

For Relief of*

Leg Cramps

Muscle Pains & Spasms

Night Cramps & Pain

60 Tablets

* Please review the disclaimer below.