Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID 918bc478-78a2-41e1-b123-f5350cf8f43a
Route
ORAL
Published
Effective Date 2021-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Melilotus Officinalis Top (3 [hp_X]) Spigelia Anthelmia (6 [hp_X]) Onion (12 [hp_X]) Atropa Belladonna Bryonia Alba Root Black Cohosh Gelsemium Sempervirens Root Nitroglycerin Magnesium Cation Strychnos Nux-vomica Seed Sanguinaria Canadensis Root Silicon Dioxide Citharacanthus Spinicrus
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-07-19

Description

Melilotus Officinalis 3X, Spigelia Anthelmia 6X, Allium Cepa 12X, Belladonna 12X, Bryonia (Alba) 12X, Cimicifuga Racemosa 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Magnesia Phosphorica 12X, Nux Vomica 12X, Sanguinaria Canadensis 12X, Silicea 12X, Tarentula Cubensis 12X.


Medication Information

Description

Melilotus Officinalis 3X, Spigelia Anthelmia 6X, Allium Cepa 12X, Belladonna 12X, Bryonia (Alba) 12X, Cimicifuga Racemosa 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Magnesia Phosphorica 12X, Nux Vomica 12X, Sanguinaria Canadensis 12X, Silicea 12X, Tarentula Cubensis 12X.

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 a cool, dry place.

Questions:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions:

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

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.

Active Ingredients:

Melilotus Officinalis 3X, Spigelia Anthelmia 6X, Allium Cepa 12X, Belladonna 12X, Bryonia (Alba) 12X, Cimicifuga Racemosa 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Magnesia Phosphorica 12X, Nux Vomica 12X, Sanguinaria Canadensis 12X, Silicea 12X, Tarentula Cubensis 12X.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Package Label Display:

BIOActive Nutritional

HEADACHE

HOMEOPATHIC

1 FL OZ (30 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Warnings: (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 a cool, dry place.

Questions: (QUESTIONS:)

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions: (DIRECTIONS:)

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

Indications: (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.

Active Ingredients: (ACTIVE INGREDIENTS:)

Melilotus Officinalis 3X, Spigelia Anthelmia 6X, Allium Cepa 12X, Belladonna 12X, Bryonia (Alba) 12X, Cimicifuga Racemosa 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Magnesia Phosphorica 12X, Nux Vomica 12X, Sanguinaria Canadensis 12X, Silicea 12X, Tarentula Cubensis 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, 25% Ethanol

Package Label Display: (PACKAGE LABEL DISPLAY:)

BIOActive Nutritional

HEADACHE

HOMEOPATHIC

1 FL OZ (30 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

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


Advanced Ingredient Data


Raw Label Data

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