Grains and Gluten Intolerances™

GRAINS AND GLUTEN INTOLERANCES- arsenicum album, bryonia, histaminum hydrochloricum, hydrastis canadensis, lycopodium clavatum, natrum muriaticum, pulsatilla, sabadilla, secale cornutum, sulphur liquid
King Bio Inc.

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.

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Drug Facts__________________________________________________________________________________________________________

HPUS active ingredients: Arsenicum album, Bryonia, Histaminum hydrochloricum, Hydrastis canadensis, Lycopodium clavatum, Natrum muriaticum, Pulsatilla, Sabadilla, Secale cornutum, Sulphur. Equal volumes of each ingredient in 12X, 24X, LM1 potencies.

Uses temporarily relieves symptoms from grains and gluten intolerances and sensitivities: gas, heartburn, headache, nausea, or diarrhea.

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Warnings

Stop use and ask your doctor if symptoms persist or worsen.

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children

Initially, depress pump until primed.
Spray one dose directly into mouth.
Ages 12 and up- 3 sprays 3 times per day.
Ages 6-12- 2 sprays 3 times per day.

Tamper resistant for your protection. Use only if safety seal is intact.

Uses temporarily relieves symptoms from grains and gluten intolerances and sensitivities:

gas
heartburn
headache
nausea
diarrhea

image description

GRAINS AND GLUTEN INTOLERANCES
arsenicum album, bryonia, histaminum hydrochloricum, hydrastis canadensis, lycopodium clavatum, natrum muriaticum, pulsatilla, sabadilla, secale cornutum, sulphur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57955-0724
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 59 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	12 [hp_X] in 59 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	12 [hp_X] in 59 mL
GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV)	GOLDENSEAL	12 [hp_X] in 59 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X] in 59 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	12 [hp_X] in 59 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	12 [hp_X] in 59 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	12 [hp_X] in 59 mL
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N)	CLAVICEPS PURPUREA SCLEROTIUM	12 [hp_X] in 59 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X] in 59 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57955-0724-2	59 mL in 1 BOTTLE, SPRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		11/19/2013

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Name	Address	ID/FEI	Business Operations
Establishment
King Bio Inc.		617901350	api manufacture(57955-0724)