The following Structured Product Label (SPL) was submitted to the FDA by Walgreen Company for the product Leg Cramps Pm (NDC 0363-7174). 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 - purpose, active ingredients, uses, warnings, otc - pregnancy or breast feeding, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
According to homeopathic indications, these ingredients provide temporary relief of symptoms such as: stiffness, limb, joint, leg pain, cramps in calves, feet and legs with accompanying occasional sleeplessness or disrupted sleep, after serious causes have been ruled out by a physician.
| Active ingredients | Purpose | |
| Calcarea Carbonica 12X HPUS | cramps in legs, calves, feet and toes | |
| Causticum 12X HPUS | occasional sleeplessness | |
| Chamomilla 6X HPUS | occasional sleeplessness | |
| Cinchona Officinalis 3X HPUS | pain in limbs and joints; cramping in legs | |
| Cuprum Metallicum 12X HPUS | cramps of limbs, charley horse cramps | |
| Lycopodium 12X HPUS | disturbed, restless sleep | |
| Magnesia Phosphorica 6X HPUS | muscle cramps | |
| Rhus Toxicodendron 6X HPUS | pain and stiffness | |
| Silicea 12X HPUS | not being able to sleep again after waking | |
| Sulphur 6X HPUS | occasional sleeplessness, frequent waking during night |
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
■ According to homeopathic indications, these ingredients provide temporary relief of symptoms such as: stiffness, limb, joint, leg pain, cramps in calves, feet and legs with accompanying occasional sleeplessness or disrupted sleep, after serious causes have been ruled out by a physician. * These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES.
• This product is intended to complement, not replace, standard medical treatment. • Initial worsening of symptoms may occur.
• If pregnant or breast-feeding, ask a health professional before use.
Stop use and ask a doctor if:
• You experience new or worsening symptoms. • Symptoms last longer than 3 days.
• Keep out of reach of children. • In case of overdose, get medical help or contact a Poison Control Center right away.
• Suitable for adults and children ages 12 and over. Children under the age of 12: Consult a physician before use. Dissolve entire tablet under tongue OR chew tablet and swallow. • Do not swallow tablet whole. • Dissolve 1-2 tablets under tongue, every 4 hours or as needed. If the initial dosage is not providing relief, take 1-2 tablets every 15 minutes, for up to 6 doses. • Take at least 10 minutes before or at least 10 minutes after eating or drinking. • Homeopathic remedies may not be effective for everyone. Individual results may vary.
• Store at room temperature 15o to 30o C (59o to 86o F). • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects or contraindications.
Copovidone, Crospovidone, Lactose, Magnesium stearate, Mannitol, Microcrystalline cellulose, Silicon dioxide, Sorbitol.
*THIS PRODUCT IS A HOMEOPATHIC REMEDY. AS SUCH, IT HAS NOT UNDERGONE REVIEW OR APPROVAL BY THE FDA AND THEREFORE HAS NOT BEEN DEMONSTRATED TO BE SAFE OR EFFECTIVE TO DIAGNOSE, TREAT, PREVENT, MITIGATE OR CURE ANY CONDITION OR DISEASE.
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Carton (Wag Ps 376823 Legcrampspm Box)
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