FDA Label for Leg Cramps Pm
View Indications, Usage & Precautions
Leg Cramps Pm Product Label
The following document was submitted to the FDA by the labeler of this product Walgreen Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
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
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.
Uses
■ 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.
Warnings
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.
Otc - Pregnancy Or Breast Feeding
• If pregnant or breast-feeding, ask a health professional before use.
Otc - Stop Use
Stop use and ask a doctor if:
• You experience new or worsening symptoms. • Symptoms last longer than 3 days.
Otc - Keep Out Of Reach Of Children
• Keep out of reach of children. • In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• 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.
Other Information
• 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.
Inactive Ingredients
Copovidone, Crospovidone, Lactose, Magnesium stearate, Mannitol, Microcrystalline cellulose, Silicon dioxide, Sorbitol.
Other
*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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