Label: SORE THROAT AND LARYNGITIS RESPONSE- aconitum napellus, antimonium crudum, arum triphyllum, borax, causticum, ferrum phosphoricum, graphites, hepar sulphuris calcareum, kali bichromicum, lac defloratum, phosphorus, selenium metallicum, spongia tosta liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 58066-7014-7 - Packager: Beaumont Bio Med
- 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 8, 2015
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ACTIVE INGREDIENT
HPUS active ingredients: Aconitum napellus, Antimonium crudum, Arum triphyllum, Borax, Causticum, Ferrum phosphoricum, Graphites, Hepar sulphuris calcareum, Kali bichromicum, Lac defloratum, Phosphorus, Selenium metallicum, Spongia tosta. Equal volumes of each ingredient in 10X, 30X, 100X potencies.
- INACTIVE INGREDIENT
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Directions:
- Hold close to mouth and spray 1 dose (3 complete pump sprays) directly in mouth 4-6 times daily until symptoms improve.
- Before initial dose, depress pump 4-5 times or until primed.
- Consult a physician for use in children under 12 years of age.
Use according to label indications and/or standard homeopathic indications.
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SORE THROAT AND LARYNGITIS RESPONSE
aconitum napellus, antimonium crudum, arum triphyllum, borax, causticum, ferrum phosphoricum, graphites, hepar sulphuris calcareum, kali bichromicum, lac defloratum, phosphorus, selenium metallicum, spongia tosta liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58066-7014 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 10 [hp_X] in 59.2 mL ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE 10 [hp_X] in 59.2 mL ARISAEMA TRIPHYLLUM ROOT (UNII: DM64K844DM) (ARISAEMA TRIPHYLLUM ROOT - UNII:DM64K844DM) ARISAEMA TRIPHYLLUM ROOT 10 [hp_X] in 59.2 mL SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE 10 [hp_X] in 59.2 mL CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM 10 [hp_X] in 59.2 mL FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 10 [hp_X] in 59.2 mL GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 10 [hp_X] in 59.2 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 10 [hp_X] in 59.2 mL POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V) POTASSIUM DICHROMATE 10 [hp_X] in 59.2 mL SKIM MILK (UNII: 6A001Y4M5A) (SKIM MILK - UNII:6A001Y4M5A) SKIM MILK 10 [hp_X] in 59.2 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 10 [hp_X] in 59.2 mL SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM 10 [hp_X] in 59.2 mL SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED 10 [hp_X] in 59.2 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58066-7014-7 59.2 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/20/2011 Labeler - Beaumont Bio Med (070624288) Registrant - Beaumont Bio Med (070624288)
