Headache Relief II

HEADACHE RELIEF II- gelsemium sempervirens, glonoinum, iris versicolor, kali carbonicum, lycopodium clavatum, natrum muriaticum, niccolum metallicum, nux vomica, sanguinaria canadensis, secale cornutum, spigelia anthelmia, sulphur liquid
New Sun 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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Headache Relief II

Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

Adult Dose: 3 Pump Sprays

Child's Dose (2-12): 2 Pump Sprays

Infants - 2 yrs. 1 Pump Spray

Warnings: If symptoms persist or worsen, seek advice of a physician. If pregnant or breast-feeding, take only on advice of physician.

Keep out of reach of children.

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

Indications: For temporary relief of symptoms from the following headaches: •migraine •sick •throbbing •occipital •morning •sun

Active Ingredients: Gelsemium sempervirens, Glonoinum, Iris versicolor, Kali carbonicum, Lycopodium clavatum, Natrum muriaticum, Niccolum metallicum, Nux vomica, Sanguinaria canadensis, Secale cornutum, Spigelia anthelmia, Sulphur. Equal volumes of each ingredient in 10X, 30X, and 100X potencies.

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

Indications: For temporary relief of symptoms from the following headaches:

migraine
sick
throbbing
occipital
morning
sun

image description

HEADACHE RELIEF II
gelsemium sempervirens, glonoinum, iris versicolor, kali carbonicum, lycopodium clavatum, natrum muriaticum, niccolum metallicum, nux vomica, sanguinaria canadensis, secale cornutum, spigelia anthelmia, sulphur liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66579-0060
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	10 [hp_X] in 59 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	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
NICKEL (UNII: 7OV03QG267) (NICKEL - UNII:7OV03QG267)	NICKEL	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
CLAVICEPS PURPUREA SCLEROTIUM (UNII: 01G9XEA93N) (CLAVICEPS PURPUREA SCLEROTIUM - UNII:01G9XEA93N)	CLAVICEPS PURPUREA SCLEROTIUM	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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66579-0060-2	59 mL in 1 BOTTLE, SPRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/28/2011

Labeler - New Sun Inc. (957251176)

Registrant - New Sun Inc. (957251176)

Name	Address	ID/FEI	Business Operations
Establishment
King Bio Inc.		617901350	manufacture(66579-0060)