Headache Freee™

Drug Facts__________________________________________________________________________________________________________

HPUS active ingredients: Belladonna, Bryonia, Capsicum, Chininum arsenicosum, Coffea cruda, Gelsemium, Glonoinum, Ignatia, Kali bic, Lycopodium, Nat mur, Nux vom, Sanguinaria, Spigelia anth, Sulphur.

Equal volumes of each ingredient in 10X, 30X, 100X, 1LM, 2LM, 3LM, 5LM potencies.

Uses for temporary relief of headache pain: throbbing, splitting, tight, dull, sick, bursting, sinus, congestive, migraine, occipital.

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, Carya ovata bark extract, citrus extract, Lonicera japonica (honeysuckle), polylysine, steviol glycosides.

Warnings

Stop use and ask your doctor if symptoms persist or worsen.
If pregnant or breast-feeding, take only on advice of a healthcare professional.

Keep out of reach of children.

Directions

Initially, depress pump until primed.
Spray one dose directly into mouth.
Adults 12 and up: 3 sprays 3 times per day.
Children 2-12: 2 sprays 3 times per day.
Children 2 mo-2 yr: 1 spray 3 times per day.

Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

Uses for temporary relief of headache pain:

throbbing
splitting
tight
dull
sick
bursting
sinus
congestive
migraine
occipital

image description

HEADACHE FREEE
belladonna, bryonia, capsicum, chininum arsenicosum, coffea cruda, gelsemium, glonoinum, ignatia, kali bic, lycopodium, nat mur, nux vom, sanguinaria, spigelia anth, sulphur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57955-0183
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	10 [hp_X] in 59 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	10 [hp_X] in 59 mL
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG)	CAPSICUM	10 [hp_X] in 59 mL
QUININE ARSENITE (UNII: 42QO5P0NLM) (QUININE - UNII:A7V27PHC7A)	QUININE ARSENITE	10 [hp_X] in 59 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	10 [hp_X] in 59 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	10 [hp_X] in 59 mL
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	10 [hp_X] in 59 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	10 [hp_X] in 59 mL
POTASSIUM DICHROMATE (UNII: T4423S18FM) (DICHROMATE ION - UNII:9LKY4BFN2V)	POTASSIUM DICHROMATE	10 [hp_X] in 59 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	10 [hp_X] in 59 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	10 [hp_X] in 59 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	10 [hp_X] in 59 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	10 [hp_X] in 59 mL
SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE)	SPIGELIA ANTHELMIA	10 [hp_X] in 59 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	10 [hp_X] in 59 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARYA OVATA BARK (UNII: X765CF609L)
CITRUS BIOFLAVONOIDS (UNII: BD70459I50)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
POLYEPSILON-LYSINE (4000 MW) (UNII: WB0M8X4TWR)
REBAUDIOSIDE A (UNII: B3FUD0528F)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57955-0183-2	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	02/14/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/14/2018

Labeler - King Bio Inc. (617901350)

Registrant - King Bio Inc. (617901350)

Name	Address	ID/FEI	Business Operations
Establishment
King Bio Inc.		617901350	manufacture(57955-0183)