Headache liquid

Otc - active ingredient section

Active Ingredients:Melilotus Officinalis, Spigelia Anthelmia, Allium Cepa, Belladonna, Bryonia, Cimicifuga Racemosa, Gelsemium Sempervirens, Glonoinum, Magnesia Phosphorica, Nux Vomica, Sanguinaria Canadensis, Silicea, Tarentula Cubensis

Otc - purpose section

Indications:For temporary relief of headache with muscular soreness of neck and shoulders, heaviness of the head, fullness all over the head, pain as if a band around the head.

Warnings section

WARNINGS:If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right

away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

Dosage & administration section

DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Inactive ingredients:

Demineralized water, 25% Ethanol.

Keep out of reach of children:

In case of overdose, get medical help or contact Poison Control Center right away.

Indications & usage section


INDICATIONS:For temporary relief of headache with muscular soreness of neck and shoulders, heaviness of the head, fullness all over the head, pain as if a band around the head.

Otc - questions section

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

Ingredients and appearance - Product information

Headache liquid- Melilotus officinalis, spigelia anthelmia, allium cepa, belladonna, bryonia, cimicifuga racemosa, gelsemium sempervirens, glonoinum

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 43857-0050
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Melilotus officinalis top ( UNII: GM6P02J2DX)( Melilotus officinalis top - UNII: GM6P02J2DX ) 3 [hp_X]in 1 mL
Spigelia anthelmia ( UNII: WYT05213GE)( Spigelia anthelmia - UNII: WYT05213GE ) 3 [hp_X]in 1 mL
Onion ( UNII: 492225Q21H)( Onion - UNII: 492225Q21H ) 12 [hp_X]in 1 mL
Atropa belladonna root ( UNII: 6MW97Q6E8M)( Atropa belladonna root - UNII: 6MW97Q6E8M ) 12 [hp_X]in 1 mL
Bryonia alba root ( UNII: T7J046YI2B)( Bryonia alba root - UNII: T7J046YI2B ) 12 [hp_X]in 1 mL
Black cohosh ( UNII: K73E24S6X9)( Black cohosh - UNII: K73E24S6X9 ) 12 [hp_X]in 1 mL
Gelsemium sempervirens root ( UNII: 639KR60Q1Q)( Gelsemium sempervirens root - UNII: 639KR60Q1Q ) 12 [hp_X]in 1 mL
Nitroglycerin ( UNII: G59M7S0WS3)( Nitroglycerin - UNII: G59M7S0WS3 ) 12 [hp_X]in 1 mL
Magnesium phosphate, dibasic trihydrate ( UNII: HF539G9L3Q)( Magnesium cation - UNII: T6V3LHY838 ) 12 [hp_X]in 1 mL
Strychnos nux-vomica seed ( UNII: 269XH13919)( Strychnos nux-vomica seed - UNII: 269XH13919 ) 12 [hp_X]in 1 mL
Sanguinaria canadensis whole ( UNII: B3XJA0OV6T)( Sanguinaria canadensis whole - UNII: B3XJA0OV6T ) 12 [hp_X]in 1 mL
Silicon dioxide ( UNII: ETJ7Z6XBU4)( Silicon dioxide - UNII: ETJ7Z6XBU4 ) 12 [hp_X]in 1 mL
Citharacanthus spinicrus ( UNII: 3Y5X6RT823)( Citharacanthus spinicrus - UNII: 3Y5X6RT823 ) 12 [hp_X]in 1 mL

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Alcohol ( UNII: 3K9958V90M)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved homeopathic USA

Labeler - BioActive Nutritional, Inc.( 624980496)

Establishment

Name ID/FEI Business Operations
BioActive Nutritional, Inc. 624980496 manufacture( 43857-0050)

Package label.principal display panel

BioActive Homeopathic

HEADACHE

1 FL OZ (30ml)