Label: SORE THROAT- echinacea purpurea, plantago major, baptisia tinctoria, phytolacca decandra, apis mellifica, belladonna, lachesis mutus, mercurius solubilis, hepar sulphuris calcareum spray
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Contains inactivated NDC Code(s)
NDC Code(s): 53173-0001-1 - Packager: Nova Aurora Corp
- 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 October 9, 2015
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- ACTIVE INGREDIENTS:
- INDICATIONS:
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WARNINGS:
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.
WARNING: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a physician promptly. Do not use more than two days or administer to children under 3 years of age unless directed by a physician.
Recommended for Professional Use.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
SORE THROAT
echinacea purpurea, plantago major, baptisia tinctoria, phytolacca decandra, apis mellifica, belladonna, lachesis mutus, mercurius solubilis, hepar sulphuris calcareum sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53173-0001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA 2 [hp_X] in 1 mL PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR 2 [hp_X] in 1 mL BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 3 [hp_X] in 1 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 3 [hp_X] in 1 mL APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 12 [hp_X] in 1 mL ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 12 [hp_X] in 1 mL LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 12 [hp_X] in 1 mL MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS 12 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 15 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength CLOVE (UNII: K48IKT5321) GOLDENSEAL (UNII: ZW3Z11D0JV) MYRRH (UNII: JC71GJ1F3L) SAGE (UNII: 065C5D077J) THYME (UNII: CW657OBU4N) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) MENTHOL (UNII: L7T10EIP3A) METHYL SALICYLATE (UNII: LAV5U5022Y) STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876) SPEARMINT OIL (UNII: C3M81465G5) Product Characteristics Color Score Shape Size Flavor MARSHMALLOW Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53173-0001-1 30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/09/2015 Labeler - Nova Aurora Corp (032439395) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(53173-0001) , api manufacture(53173-0001) , label(53173-0001) , pack(53173-0001)
