The following Structured Product Label (SPL) was submitted to the FDA by Saimdang Cosmetics Co., Ltd for the product Pure Calcium (NDC 51220-3001). 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, description, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Otc - Active Ingredient
Active ingredients: Calcium, Manganese, Vitamin D3
Description
• UsesCalcium: Woman susceptible to osteoporosis with menopausePromote the bone growth of children and teenagersSupplement calcium during pregnancy and lactationVitamin D: maintain blood levels of calciumManganese: needed for healthy skin, bone, and cartilageformation, as well as glucose tolerance unconditioningof the retina• Warning, Patients with a history of idiosyncrasy and allergy may havea higher risk of a hypersensitivity, Please check the rawmaterials in this product• Direction, take 2 tablet daily. (can be tablet.)• Other Information, Keep at room temperature in a dark dry place. Keep out of reach of children
Otc - Purpose
• UsesCalcium: Woman susceptible to osteoporosis with menopausePromote the bone growth of children and teenagersSupplement calcium during pregnancy and lactationVitamin D: maintain blood levels of calciumManganese: needed for healthy skin, bone, and cartilageformation, as well as glucose tolerance unconditioningof the retina
Otc - Keep Out Of Reach Of Children
• Other Information, Keep at room temperature in a dark dry place. Keep out of reach of children
Indications & Usage
• Direction, take 2 tablet daily. (can be tablet.)
Warnings
• Warning, Patients with a history of idiosyncrasy and allergy may havea higher risk of a hypersensitivity, Please check the rawmaterials in this product
Dosage & Administration
• Direction, take 2 tablet daily. (can be tablet.)
Inactive Ingredient
Inactive ingredients: sorbitol, milk, cocoa, xylitol, magnesium, safflower, stevia, vitamin K1
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