Label: SWL ULTRA ADVANTAGE- abrotanum, anacardium orientale, baryta carbonica, calcarea carbonica, calcarea phosphorica, cinchona officinalis, fucus vesiculosus, glandula suprarenalis suis, graphites, helleborus niger, hepar suis, hypothalamus, lycopodium clavatum, magnesia phosphorica, nicotinamidum, pancreas suis, solidago virgaurea, thymolum, thymus serpyllum, thyroidinum liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 69727-0001-1 - Packager: ELTTAC Inc DBA SWL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated May 3, 2016
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
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 INGREDIENT
- INDICATIONS & USAGE
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WARNINGS
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
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DOSAGE & ADMINISTRATION
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.
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SWL ULTRA ADVANTAGE
abrotanum, anacardium orientale, baryta carbonica, calcarea carbonica, calcarea phosphorica, cinchona officinalis, fucus vesiculosus, glandula suprarenalis suis, graphites, helleborus niger, hepar suis, hypothalamus, lycopodium clavatum, magnesia phosphorica, nicotinamidum, pancreas suis, solidago virgaurea, thymolum, thymus serpyllum, thyroidinum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69727-0001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARTEMISIA ABROTANUM FLOWERING TOP (UNII: QG07G580U0) (ARTEMISIA ABROTANUM FLOWERING TOP - UNII:QG07G580U0) ARTEMISIA ABROTANUM FLOWERING TOP 8 [hp_X] in 30 mL SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE 8 [hp_X] in 30 mL BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE 8 [hp_X] in 30 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 8 [hp_X] in 30 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 8 [hp_X] in 30 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 8 [hp_X] in 30 mL FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS 8 [hp_X] in 30 mL SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND 8 [hp_X] in 30 mL GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 8 [hp_X] in 30 mL HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT 8 [hp_X] in 30 mL PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER 8 [hp_X] in 30 mL BOS TAURUS HYPOTHALAMUS (UNII: S6G2NLH4Y7) (BOS TAURUS HYPOTHALAMUS - UNII:S6G2NLH4Y7) BOS TAURUS HYPOTHALAMUS 8 [hp_X] in 30 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 8 [hp_X] in 30 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 8 [hp_X] in 30 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 8 [hp_X] in 30 mL SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY) SUS SCROFA PANCREAS 8 [hp_X] in 30 mL SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP 12 [hp_X] in 30 mL THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL 8 [hp_X] in 30 mL THYMUS SERPYLLUM (UNII: 86H4S6K51N) (THYMUS SERPYLLUM - UNII:86H4S6K51N) THYMUS SERPYLLUM 8 [hp_X] in 30 mL THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED 8 [hp_X] in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69727-0001-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 05/15/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/15/2015 Labeler - ELTTAC Inc DBA SWL (833585685) Registrant - ELTTAC Inc DBA SWL (833585685) Establishment Name Address ID/FEI Business Operations King Bio, INC 617901350 manufacture(69727-0001)
