Label: AMETHYST ROSA capsule
- NDC Code(s): 48951-1363-7
- Packager: Uriel Pharmacy, Inc.
- 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 January 29, 2024
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
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ACTIVE INGREDIENT
Active Ingredients: Amethyst (Nat. silicic acid anhydrate with traces of manganese and iron) 2X, Carbo (charcoal) 2X, Fumaria (Fumitory) 3X, Absinthium (Wormwood) 4X, Betula (Birch) 4X, Calamus (Sweet flag) 4X, Chamomilla (Chamomile) 4X, Cochlearia (Common scurvy grass) 4X, Gentiana (Yellow gentian) 4X, Geum urbanum (Herb bennet) 4X, Oxalis (Wood sorrel) 4X, Rosa (Garden rose) 4X, Urtica dioica (Stinging nettle) 4X, Zingiberis (Ginger) 4X, Antimonite (Nat. antimony trisulfide) 5x, Piper nigrum (Black pepper) 5X. Hematite (Red iron ore) 6X, Graphite (Foliated crystalline carbon) 15X,
- INACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use. Do not use if safety seal is broken or missing.
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INGREDIENTS AND APPEARANCE
AMETHYST ROSA
amethyst rosa capsuleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:48951-1363 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WORMWOOD (UNII: F84709P2XV) (WORMWOOD - UNII:F84709P2XV) WORMWOOD 4 [hp_X] BLACK PEPPER (UNII: KM66971LVF) (BLACK PEPPER - UNII:KM66971LVF) BLACK PEPPER 5 [hp_X] ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F) (ACORUS CALAMUS ROOT - UNII:XY1K7KIQ0F) ACORUS CALAMUS ROOT 4 [hp_X] COCHLEARIA OFFICINALIS FLOWERING TOP (UNII: M87UN67CKR) (COCHLEARIA OFFICINALIS FLOWERING TOP - UNII:M87UN67CKR) COCHLEARIA OFFICINALIS FLOWERING TOP 4 [hp_X] GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS) GENTIANA LUTEA ROOT 4 [hp_X] BETULA PUBESCENS BARK (UNII: 3R504894L9) (BETULA PUBESCENS BARK - UNII:3R504894L9) BETULA PUBESCENS BARK 4 [hp_X] GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER 4 [hp_X] SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 2 [hp_X] URTICA DIOICA (UNII: 710FLW4U46) (URTICA DIOICA - UNII:710FLW4U46) URTICA DIOICA 4 [hp_X] ROSA RUGOSA FLOWER (UNII: 969IQC5YJU) (ROSA RUGOSA FLOWER - UNII:969IQC5YJU) ROSA RUGOSA FLOWER 4 [hp_X] GEUM URBANUM ROOT (UNII: 33P1Z2B61F) (GEUM URBANUM ROOT - UNII:33P1Z2B61F) GEUM URBANUM ROOT 4 [hp_X] SEDUM ROSEUM WHOLE (UNII: RH0WP583U3) (SEDUM ROSEUM WHOLE - UNII:RH0WP583U3) SEDUM ROSEUM WHOLE 4 [hp_X] GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 15 [hp_X] CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 4 [hp_X] OXALIS STRICTA WHOLE (UNII: 3STW243384) (OXALIS STRICTA WHOLE - UNII:3STW243384) OXALIS STRICTA WHOLE 4 [hp_X] ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE 5 [hp_X] ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 2 [hp_X] FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL) (FUMARIA OFFICINALIS FLOWERING TOP - UNII:VH659J61ZL) FUMARIA OFFICINALIS FLOWERING TOP 3 [hp_X] FERRIC OXIDE RED (UNII: 1K09F3G675) (FERRIC OXIDE RED - UNII:1K09F3G675) FERRIC OXIDE RED 6 [hp_X] Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85) CARAWAY OIL (UNII: C2J9B08Q3I) ANISE OIL (UNII: 6Y89129C8H) POWDERED CELLULOSE (UNII: SMD1X3XO9M) Product Characteristics Color white Score no score Shape CAPSULE Size 23mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48951-1363-7 75 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 09/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/01/2009 Labeler - Uriel Pharmacy, Inc. (043471163) Establishment Name Address ID/FEI Business Operations Uriel Pharmacy, Inc. 043471163 manufacture(48951-1363)