Label: REGEN HP (cinnamomum, echinacea- angustifolia, hydrastis canadensis, lappa major, trifolium pratense, viscum album liquid
- NDC Code(s): 44911-0720-1
- Packager: Energique, 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 September 24, 2024
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- ACTIVE INGREDIENTS:
- PURPOSE:
- USES:
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WARNINGS:
Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult physician promptly. Do not use more than 2 days or administer to children under 3 years of age unless directed by a physician.
Stop use and ask a doctor if symptoms persist for more than 2 days.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. 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:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
REGEN HP
cinnamomum, echinacea (angustifolia), hydrastis canadensis, lappa major, trifolium pratense, viscum album liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:44911-0720 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CINNAMON (UNII: 5S29HWU6QB) (CINNAMON - UNII:5S29HWU6QB) CINNAMON 12 [hp_X] in 1 mL ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE 12 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 12 [hp_X] in 1 mL ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT 12 [hp_X] in 1 mL TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER 12 [hp_X] in 1 mL VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:44911-0720-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 09/24/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/24/2024 Labeler - Energique, Inc. (789886132) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(44911-0720) , api manufacture(44911-0720) , label(44911-0720) , pack(44911-0720)