Label: AMETHYST ROSA capsule
- NDC Code(s): 48951-1361-7
- 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 April 20, 2023
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- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Vegetable capsules, Diatomaceous earth, Distilled water, Rose petal extract, Anise oil, Caraway oil
Hematite (Red iron ore), Absinthium (Wormwood), Betula (Borage), Calamus (Sweet flag), Chamomilla (Chamomile), Cochlearia (Common scurvy grass), Gentiana (Yellow gentian), Geum urbanum (Herb bennet), Oxalis (Wood sorrel), Rosa (Garden rose), Urtica dioica (Stinging nettle), Urtica dioica (Stinging nettle), Zingiberis (Ginger), Piper nigrum (Black pepper). - PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
Allergen Statement: This product was produced on equipment that also processes products that contain lactose.
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:48951-1361 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 2 [hp_X] in 1 g GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 15 [hp_X] in 1 g ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE 5 [hp_X] in 1 g ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 2 [hp_X] in 1 g FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL) (FUMARIA OFFICINALIS FLOWERING TOP - UNII:VH659J61ZL) FUMARIA OFFICINALIS FLOWERING TOP 3 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) WORMWOOD (UNII: F84709P2XV) URTICA DIOICA LEAF (UNII: X6M0DRN46Q) BLACK PEPPER (UNII: KM66971LVF) DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85) ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F) COCHLEARIA OFFICINALIS FLOWERING TOP (UNII: M87UN67CKR) GENTIANA LUTEA ROOT (UNII: S72O3284MS) BETULA PUBESCENS BARK (UNII: 3R504894L9) GINGER (UNII: C5529G5JPQ) URTICA DIOICA ROOT (UNII: J8HE8A6E5T) CARAWAY OIL (UNII: C2J9B08Q3I) ROSA RUGOSA FLOWER (UNII: 969IQC5YJU) ANISE OIL (UNII: 6Y89129C8H) GEUM URBANUM ROOT (UNII: 33P1Z2B61F) SEDUM ROSEUM WHOLE (UNII: RH0WP583U3) POWDERED CELLULOSE (UNII: SMD1X3XO9M) CHAMOMILE (UNII: FGL3685T2X) OXALIS STRICTA WHOLE (UNII: 3STW243384) FERRIC OXIDE RED (UNII: 1K09F3G675) 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:48951-1361-7 75 g 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(48951-1361)
