Label: SINUS RESPONSE- apis mellifica, baptisia tinctoria, colocynthis, hepar sulphuris calcareum, histaminum hydrochloricum, hydrastis canadensis, ignatia amara, kali bichromicum, lac defloratum, lemna minor, mercurius vivus, pulsatilla, rhus toxicodendron, sabadilla, thuja occidentalis liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 58066-7013-7 - 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 September 12, 2016
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
HPUS active ingredients: Apis mellifica, Baptisia tinctoria, Colocynthis, Hepar sulphuris calcareum, Histaminum hydrochloricum, Hydrastis canadensis, Ignatia amara, Kali bichromicum, Lac defloratum, Lemna minor, Mercurius vivus, Pulsatilla, Rhus toxicodendron, Sabadilla, Thuja occidentalis. 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
- OTHER SAFETY INFORMATION
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SINUS RESPONSE
apis mellifica, baptisia tinctoria, colocynthis, hepar sulphuris calcareum, histaminum hydrochloricum, hydrastis canadensis, ignatia amara, kali bichromicum, lac defloratum, lemna minor, mercurius vivus, pulsatilla, rhus toxicodendron, sabadilla, thuja occidentalis liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58066-7013 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 10 [hp_X] in 59.2 mL BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT 10 [hp_X] in 59.2 mL CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17) CITRULLUS COLOCYNTHIS FRUIT PULP 10 [hp_X] in 59.2 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 10 [hp_X] in 59.2 mL HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 10 [hp_X] in 59.2 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 10 [hp_X] in 59.2 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 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 LEMNA MINOR (UNII: 621HHM46SV) (LEMNA MINOR - UNII:621HHM46SV) LEMNA MINOR 10 [hp_X] in 59.2 mL MERCURY (UNII: FXS1BY2PGL) (MERCURY - UNII:FXS1BY2PGL) MERCURY 10 [hp_X] in 59.2 mL PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 10 [hp_X] in 59.2 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 59.2 mL SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO) SCHOENOCAULON OFFICINALE SEED 10 [hp_X] in 59.2 mL THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 10 [hp_X] in 59.2 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58066-7013-7 59.2 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 09/12/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/12/2016 Labeler - Beaumont Bio Med (070624288) Registrant - Beaumont Bio Med (070624288) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(58066-7013)
