Label: HEADACHE RELIEF- belladonna, bryonia, capsicum annuum, chininum arsenicosum, coffea cruda, gelsemium sempervirens, glonoinum, ignatia amara, kali bichromicum, lycopodium clavatum, natrum muriaticum, nux vomica, sanguinaria canadensis, spigelia anthelmia, sulphur liquid
- NDC Code(s): 57955-2830-2
- 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 18, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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.Consult a physician for use in
children under 6 years of age.Use additionally as needed, up
to 6 times per day.Reference image:Headache Relief.jpg
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OTHER SAFETY INFORMATION
Other information
Tamper resistant for your protection.
Use only if safety seal is intact.
Keep carton for complete drug facts and product information.
Questions? Call 866.298.2740
King Bio, Inc. 3 Westside Drive
Asheville, NC 2806 USA
FDA Reg. #1053442
For latest product information and instructions: www.DrKings.com
Reference image:Headache Relief.jpg
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Inactive Ingredients
Citrus Extract (ascorbic acid, citric acid, citrus aurantium amara fruit extract, citrus aurantium sinensis peel extract, citrus reticulata fruit extact, demineralized water, glycerin, lactic acid), Honeysuckle (Lonicera japonica), Polylysine, Purified Water, Shagbark Hickory (Carya Ovata) Bark Extract, Steviol (Steviol Glycosides).
Reference image:Headache Relief.jpg
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Active ingredients
Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
potencies.Belladonna, Bryonia, Capsicum annuum, Chininum arsenicosum, Coffea cruda, Gelsemium sempervirens, Glonoinum, Ignatia amara,
Kali bichromicum, Lycopodium clavatum, Natrum muriaticum, Nux vomica, Sanguinaria canadensis, Spigelia anthelmia, Sulphur.
HPUS indicates the active ingredients are in the official Homeopathic Pharmacopeia of the United States.
Reference image:Headache Relief.jpg
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Uses
Uses for temporary relief of various types of headache, such as:
throbbing
splitting
tight
dull
sick
bursting
sinus
congestive
migraine
occipital
morning headache
band feeling around the head
sun headache
as per various homeopathic materia medicas. Claims based
on traditional homeopathic practice, not accepted medical
evidence. These uses have not been evaluated by the FDA,
and product has not been clinically tested.Reference image:Headache Relief.jpg
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Warnings
Stop use and consult a physician if symptoms worsen or
persist for more than 7 days.If pregnant or breast-feeding, ask a healthcare professional
before use.Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center immediately.
Reference image:Headache Relief.jpg
- KEEP OUT OF REACH OF CHILDREN
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PURPOSE
Equal volumes of each HPUS** ingredient in 10X, 30X, and 1LM
potencies.Belladonna .......................................throbbing in head and eyes
Bryonia ...................................splitting headache, sinus pressure
Capsicum annuum .............................bursting headache, hot face
Chininum arsenicosum............................................dull headache
Coffea cruda........................................................tight head pain
Gelsemium sempervirens....................... band feeling around head
Glonoinum ............................................................sun headache
Ignatia amara ........................................... congestive headaches
Kali bichromicum ....................................headache over eyebrows
Lycopodium clavatum............................................pain in temples
Natrum muriaticum ...........................throbbing, blinding headache
Nux vomica.............................................headache from sunshine
Sanguinaria canadensis ........................................burning in eyes
Spigelia anthelmia ...........................pain as if a band around head
Sulphur....................................sick headache, pressure in temples
**“HPUS” indicates the active ingredients are in the official
Homeopathic Pharmacopeia of the United States.Reference image:Headache Relief.jpg
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEADACHE RELIEF
belladonna, bryonia, capsicum annuum, chininum arsenicosum, coffea cruda, gelsemium sempervirens, glonoinum, ignatia amara, kali bichromicum, lycopodium clavatum, natrum muriaticum, nux vomica, sanguinaria canadensis, spigelia anthelmia, sulphur liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57955-2830 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 WHOLE (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA WHOLE 10 [hp_X] in 59 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 10 [hp_X] in 59 mL Inactive Ingredients Ingredient Name Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T) ORANGE PEEL (UNII: TI9T76XD44) CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y) BENZYLPENICILLOYL POLYLYSINE (UNII: 76479814OY) CARYA OVATA BARK (UNII: X765CF609L) STEVIOL (UNII: 4741LYX6RT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57955-2830-2 1 in 1 CARTON 07/27/2022 1 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/22/2022 Labeler - King Bio Inc. (617901350) Registrant - King Bio Inc. (617901350) Establishment Name Address ID/FEI Business Operations King Bio Inc. 617901350 manufacture(57955-2830) , api manufacture(57955-2830)
