MedPath
FDA Approval

Headache Relief

King Bio Inc. (DUNS: 617901350)

May 20, 2025

HUMAN OTC DRUG LABEL

Belladonna(10 [hp_X] in 59 mL)
bryonia alba root(10 [hp_X] in 59 mL)
Capsicum(10 [hp_X] in 59 mL)
Arabica coffee bean(10 [hp_X] in 59 mL)
Nitroglycerin(10 [hp_X] in 59 mL)
strychnos ignatii seed(10 [hp_X] in 59 mL)
lycopodium clavatum spore(10 [hp_X] in 59 mL)
Sodium chloride(10 [hp_X] in 59 mL)
sanguinaria canadensis root(10 [hp_X] in 59 mL)
spigelia anthelmia whole(10 [hp_X] in 59 mL)
Sulfur(10 [hp_X] in 59 mL)
Gelsemium sempervirens Extract(10 [hp_X] in 59 mL)
Quinine(10 [hp_X] in 59 mL)
Nux vomica extract(10 [hp_X] in 59 mL)
Potassium(10 [hp_X] in 59 mL)

Registrants (1)

King Bio Inc.

617901350

Manufacturing Establishments (1)

King Bio Inc.

King Bio Inc.

King Bio Inc.

617901350

Products (1)

Headache Relief

57955-2830

ORAL

May 20, 2025

BelladonnaActive
Code: WQZ3G9PF0HClass: ACTIBQuantity: 10 [hp_X] in 59 mL
bryonia alba rootActive
Code: T7J046YI2BClass: ACTIBQuantity: 10 [hp_X] in 59 mL
CapsicumActive
Code: 00UK7646FGClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Arabica coffee beanActive
Code: 3SW678MX72Class: ACTIBQuantity: 10 [hp_X] in 59 mL
NitroglycerinActive
Code: G59M7S0WS3Class: ACTIBQuantity: 10 [hp_X] in 59 mL
strychnos ignatii seedActive
Code: 1NM3M2487KClass: ACTIBQuantity: 10 [hp_X] in 59 mL
lycopodium clavatum sporeActive
Code: C88X29Y479Class: ACTIBQuantity: 10 [hp_X] in 59 mL
Sodium chlorideActive
Code: 451W47IQ8XClass: ACTIBQuantity: 10 [hp_X] in 59 mL
sanguinaria canadensis rootActive
Code: N9288CD508Class: ACTIBQuantity: 10 [hp_X] in 59 mL
spigelia anthelmia wholeActive
Code: WYT05213GEClass: ACTIBQuantity: 10 [hp_X] in 59 mL
SulfurActive
Code: 70FD1KFU70Class: ACTIBQuantity: 10 [hp_X] in 59 mL
ASCORBIC ACIDInactive
Code: PQ6CK8PD0RClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
CITRUS AURANTIUM FRUIT OILInactive
Code: 59JDQ5VT0TClass: IACT
ORANGE PEELInactive
Code: TI9T76XD44Class: IACT
CITRUS RETICULATA FRUIT OILInactive
Code: 25P9H3QU5EClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
LACTIC ACID, UNSPECIFIED FORMInactive
Code: 33X04XA5ATClass: IACT
LONICERA JAPONICA FLOWERInactive
Code: 4465L2WS4YClass: IACT
POLYEPSILON-LYSINE (4000 MW)Inactive
Code: WB0M8X4TWRClass: IACT
CARYA OVATA BARKInactive
Code: X765CF609LClass: IACT
STEVIOLInactive
Code: 4741LYX6RTClass: IACT
Gelsemium sempervirens ExtractActive
Code: 639KR60Q1QClass: ACTIBQuantity: 10 [hp_X] in 59 mL
QuinineActive
Code: 42QO5P0NLMClass: ACTIBQuantity: 10 [hp_X] in 59 mL
Nux vomica extractActive
Code: 269XH13919Class: ACTIBQuantity: 10 [hp_X] in 59 mL
PotassiumActive
Code: T4423S18FMClass: ACTIBQuantity: 10 [hp_X] in 59 mL

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image description Headache Relief.jpg

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

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 - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

INACTIVE INGREDIENT SECTION

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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