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Headache Relief

Headache Relief

Approved
Approval ID

32c28bea-2ce2-415a-87b0-28163bdf508c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

King Bio Inc.

DUNS: 617901350

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

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

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code57955-2830
Product Classification
G
Generic Name
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
Product Specifications
Route of AdministrationORAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (27)

ATROPA BELLADONNAActive
Quantity: 10 [hp_X] in 59 mL
Code: WQZ3G9PF0H
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 10 [hp_X] in 59 mL
Code: T7J046YI2B
Classification: ACTIB
CAPSICUMActive
Quantity: 10 [hp_X] in 59 mL
Code: 00UK7646FG
Classification: ACTIB
ARABICA COFFEE BEANActive
Quantity: 10 [hp_X] in 59 mL
Code: 3SW678MX72
Classification: ACTIB
NITROGLYCERINActive
Quantity: 10 [hp_X] in 59 mL
Code: G59M7S0WS3
Classification: ACTIB
STRYCHNOS IGNATII SEEDActive
Quantity: 10 [hp_X] in 59 mL
Code: 1NM3M2487K
Classification: ACTIB
LYCOPODIUM CLAVATUM SPOREActive
Quantity: 10 [hp_X] in 59 mL
Code: C88X29Y479
Classification: ACTIB
SODIUM CHLORIDEActive
Quantity: 10 [hp_X] in 59 mL
Code: 451W47IQ8X
Classification: ACTIB
SANGUINARIA CANADENSIS ROOTActive
Quantity: 10 [hp_X] in 59 mL
Code: N9288CD508
Classification: ACTIB
SPIGELIA ANTHELMIA WHOLEActive
Quantity: 10 [hp_X] in 59 mL
Code: WYT05213GE
Classification: ACTIB
SULFURActive
Quantity: 10 [hp_X] in 59 mL
Code: 70FD1KFU70
Classification: ACTIB
ASCORBIC ACIDInactive
Code: PQ6CK8PD0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
CITRUS AURANTIUM FRUIT OILInactive
Code: 59JDQ5VT0T
Classification: IACT
ORANGE PEELInactive
Code: TI9T76XD44
Classification: IACT
CITRUS RETICULATA FRUIT OILInactive
Code: 25P9H3QU5E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5AT
Classification: IACT
LONICERA JAPONICA FLOWERInactive
Code: 4465L2WS4Y
Classification: IACT
POLYEPSILON-LYSINE (4000 MW)Inactive
Code: WB0M8X4TWR
Classification: IACT
CARYA OVATA BARKInactive
Code: X765CF609L
Classification: IACT
STEVIOLInactive
Code: 4741LYX6RT
Classification: IACT
GELSEMIUM SEMPERVIRENS ROOTActive
Quantity: 10 [hp_X] in 59 mL
Code: 639KR60Q1Q
Classification: ACTIB
QUININE ARSENITEActive
Quantity: 10 [hp_X] in 59 mL
Code: 42QO5P0NLM
Classification: ACTIB
STRYCHNOS NUX-VOMICA SEEDActive
Quantity: 10 [hp_X] in 59 mL
Code: 269XH13919
Classification: ACTIB
POTASSIUM DICHROMATEActive
Quantity: 10 [hp_X] in 59 mL
Code: T4423S18FM
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 11/18/2022

image description Headache Relief.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 11/18/2022

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

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 11/18/2022

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 11/18/2022

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 11/18/2022

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 11/18/2022

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

WARNINGS SECTION

LOINC: 34071-1Updated: 11/18/2022

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 11/18/2022

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 11/18/2022

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

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Headache Relief - FDA Drug Approval Details