Label: ULTRA ADVANTAGE (abrotanum (artemisia abrotanum), anacardium orientale, fucus vesiculosus, helleborus niger, hypothalamus suis, lycopodium clavatum, thymolum, thymus serpyllum, thyroidinum- bovine, glandula suprarenalis suis, hepar suis, pancreas suis, cinchona officinalis, nicotinamidum, baryta carbonica, calcarea carbonica, calcarea phosphorica, magnesia phosphorica, solidago virgaurea, graphites liquid
- NDC Code(s): 69727-0003-1
- 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 September 3, 2019
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ACTIVE INGREDIENTS:
Abrotanum (Artemisia Abrotanum) 8X, Anacardium Orientale 8X, Fucus Vesiculosus 8X, Helleborus Niger 8X, Hypothalamus Suis 8X, Lycopodium Clavatum 8X, Thymolum 8X, Thymus Serpyllum 8X, Thyroidinum (Bovine) 8X, Glandula Suprarenalis Suis 8X, 12X, 16X, Hepar Suis 8X, 12X, 16X, Pancreas Suis 8X, 12X, 16X, Cinchona Officinalis 8X, 32C, Nicotinamidum 8X, 32C, Baryta Carbonica 12X Calcarea Carbonica 12X, Calcarea Phosphorica 12X, Magnesia Phosphorica 12X, Solidago Virgaurea 12X, Graphites 12X, 32C.
- INDICATIONS:
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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:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
ULTRA ADVANTAGE
abrotanum (artemisia abrotanum), anacardium orientale, fucus vesiculosus, helleborus niger, hypothalamus suis, lycopodium clavatum, thymolum, thymus serpyllum, thyroidinum (bovine), glandula suprarenalis suis, hepar suis, pancreas suis, cinchona officinalis, nicotinamidum, baryta carbonica, calcarea carbonica, calcarea phosphorica, magnesia phosphorica, solidago virgaurea, graphites liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69727-0003 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 1 mL SEMECARPUS ANACARDIUM JUICE (UNII: Y0F0BU8RDU) (SEMECARPUS ANACARDIUM JUICE - UNII:Y0F0BU8RDU) SEMECARPUS ANACARDIUM JUICE 8 [hp_X] in 1 mL FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS 8 [hp_X] in 1 mL HELLEBORUS NIGER ROOT (UNII: 608DGJ6815) (HELLEBORUS NIGER ROOT - UNII:608DGJ6815) HELLEBORUS NIGER ROOT 8 [hp_X] in 1 mL SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79) SUS SCROFA HYPOTHALAMUS 8 [hp_X] in 1 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 8 [hp_X] in 1 mL THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL 8 [hp_X] in 1 mL THYMUS SERPYLLUM (UNII: 86H4S6K51N) (THYMUS SERPYLLUM - UNII:86H4S6K51N) THYMUS SERPYLLUM 8 [hp_X] in 1 mL THYROID, BOVINE (UNII: MN18OTN73W) (THYROID, BOVINE - UNII:MN18OTN73W) THYROID, BOVINE 8 [hp_X] in 1 mL SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND 8 [hp_X] in 1 mL PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER 8 [hp_X] in 1 mL SUS SCROFA PANCREAS (UNII: 9Y3J3362RY) (SUS SCROFA PANCREAS - UNII:9Y3J3362RY) SUS SCROFA PANCREAS 8 [hp_X] in 1 mL CINCHONA OFFICINALIS BARK (UNII: S003A158SB) (CINCHONA OFFICINALIS BARK - UNII:S003A158SB) CINCHONA OFFICINALIS BARK 8 [hp_X] in 1 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 8 [hp_X] in 1 mL BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE 12 [hp_X] in 1 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 12 [hp_X] in 1 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 12 [hp_X] in 1 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 12 [hp_X] in 1 mL SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP 12 [hp_X] in 1 mL GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69727-0003-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 09/03/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/03/2019 Labeler - ELTTAC Inc DBA SWL (833585685) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(69727-0003) , api manufacture(69727-0003) , label(69727-0003) , pack(69727-0003)
