The following Structured Product Label (SPL) was submitted to the FDA by Elttac Inc Dba Swl for the product Swl Ultra Advantage (NDC 69727-0001). 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, inactive ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, otc - purpose, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredients: Abrotanum 8X, Anacardium orientale 8X, Baryta carbonica 8X, Calcarea carbonica 8X, Calcarea phosphorica 8X, Cinchona officinalis 8X, 32C, Fucus vesiculosus 8X, Glandula suprarenalis suis 8X, 12X, 16X, Graphites 8X, 32C, Helleborus niger 8X, Hepar suis 8X, 12X, 16X, Hypothalamus 8X, Lycopodium clavatum 8X, Magnesia phosphorica 8X, Nicotinamidum 8X, 32C, Pancreas suis 8X, 12X, 16X Solidago virgaurea 12X, Thymolum 8X, Thymus serpyllum 8X, Thyroidinum 8X.
Inactive ingredients: Alcohol (15 % v/v), glycerin (10 % v/v), purified water
Indications: For temporary relief of symptoms related to excess appetite, stress, cravings, regulation of fat metabolism, emotional eating & detoxification.
Warnings: Stop use and ask your doctor if symptoms persist or worsen. If pregnant or breast-feeding, take only on advice of a healthcare professional. Keep out of reach of children. Contains alcohol. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.
Keep out of reach of children.
Directions: Shake bottle vigorously 10 times prior to use. Apply three sprays under the tongue twice daily, upon awakening and before sleeping. Do not eat, drink, or brush your teeth within 5-10 minutes before or after taking this product. Consult a physician prior to use in children under 12 years of age.
Indications: For temporary relief of symptoms related to:
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