Label: FOOD INTOLERANCES- aethusa cynapium, calcarea carbonica, cucurbita pepo, semen, gambogia, histaminum hydrochloricum, hydrastis canadensis, lycopodium clavatum, natrum carbonicum, nitricum acidum, nux vomica, ovi gallinae pellicula, phosphorus, pulsatilla, sulphur liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 57955-8300-1 - Packager: King Bio 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 November 4, 2013
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ACTIVE INGREDIENT
Drug Facts
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Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.
HPUS active ingredients: Aethusa cynapium, Calcarea carbonica, Cucurbita pepo, semen, Gambogia, Histaminum hydrochloricum, Hydrastis canadensis, Lycopodium clavatum, Natrum carbonicum, Nitricum acidum, Nux vomica, Ovi gallinae pellicula, Phosphorus, Pulsatilla, Sulphur.
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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PURPOSE
Drug Facts
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HPUS active ingredients Purpose
Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.
Aethusa cynapium..........................................................................headache, irritability
Calcarea carbonica.........................................................................aversion to meat, fat and milk
Cucurbita pepo, semen...................................................................nausea after eating
Gambogia.....................................................................................sneezing, diarrhea
Histaminum hydrochloricum............................................................stomach cramps
Hydrastis canadensis......................................................................sensitivities to bread or vegetables
Lycopodium clavatum.....................................................................indigestion
Natrum carbonicum........................................................................sensitivities to milk, diarrhea
Nitricum acidum.............................................................................constipation
Nux vomica...................................................................................nausea after eating, stomach cramps
Ovi gallinae pellicula.......................................................................sensitivities to eggs
Phosphorus....................................................................................sensitivities to salt, nausea
Pulsatilla........................................................................................gas, heartburn, bloating
Sulphur..........................................................................................loss of appetite, sensitivities to dairy
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INGREDIENTS AND APPEARANCE
FOOD INTOLERANCES
aethusa cynapium, calcarea carbonica, cucurbita pepo, semen, gambogia, histaminum hydrochloricum, hydrastis canadensis, lycopodium clavatum, natrum carbonicum, nitricum acidum, nux vomica, ovi gallinae pellicula, phosphorus, pulsatilla, sulphur liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-8300 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AETHUSA CYNAPIUM (UNII: M6936L953C) (AETHUSA CYNAPIUM - UNII:M6936L953C) AETHUSA CYNAPIUM 10 [hp_X] in 29.6 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X] in 29.6 mL PUMPKIN SEED (UNII: GH30P1VXK2) (PUMPKIN SEED - UNII:GH30P1VXK2) PUMPKIN SEED 10 [hp_X] in 29.6 mL GAMBOGE (UNII: 7556HJ7587) (GAMBOGE - UNII:7556HJ7587) GAMBOGE 10 [hp_X] in 29.6 mL HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3) HISTAMINE DIHYDROCHLORIDE 10 [hp_X] in 29.6 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 10 [hp_X] in 29.6 mL LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE 10 [hp_X] in 29.6 mL SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D) SODIUM CARBONATE 10 [hp_X] in 29.6 mL NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID 10 [hp_X] in 29.6 mL STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 10 [hp_X] in 29.6 mL EGG SHELL MEMBRANE (UNII: N7QBR4212V) (EGG SHELL MEMBRANE - UNII:N7QBR4212V) EGG SHELL MEMBRANE 10 [hp_X] in 29.6 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 10 [hp_X] in 29.6 mL PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS 10 [hp_X] in 29.6 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 [hp_X] in 29.6 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-8300-1 1 in 1 CARTON 1 29.6 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/04/2013 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 api manufacture(57955-8300)