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

Food Intolerances by

Drug Labeling and Warnings

Food Intolerances by is a Homeopathic medication manufactured, distributed, or labeled by King Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

____________________________________________________________________________________________________________

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

Uses for temporary relief of symptoms associated with food intolerances and sensitivities:

• headache
• irritability
• stomach cramps and indigestion
• nausea
• gas, heartburn and bloating
• constipation
• diarrhea
• sensitivities to meat, fat, salt, dairy, starches and vegetables.

WARNINGS

Warnings

• Stop use and ask a doctor if symptoms persist or worsen.
• If pregnant or breast-feeding, ask a healthcare professional before use.

KEEP OUT OF REACH OF CHILDREN

• Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions:

• Initially, depress pump until primed.
• Spray one dose directly into mouth.
• Adults: 3 sprays 3 times per day.
• Children ages 6-12: 2 sprays 3 times per day.
• Use additionally as needed, up to 6 times per day.

OTHER SAFETY INFORMATION

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

• This product is intended to complement, not replace, standard medical care.

INACTIVE INGREDIENT

Inactive Ingredients: Citric acid, potassium sorbate, purified water.

PURPOSE

Drug Facts

__________________________________________________________________________________________________________________

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

PRINCIPAL DISPLAY PANEL

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 liquid

Product 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)