Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 7dfdaf34-fd70-40cb-a2b6-0f2325989e7c
Route
ORAL
Published
Effective Date 2014-08-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Milk Thistle (1 [hp_X]) Tanacetum Parthenium (6 [hp_X]) Claviceps Purpurea Sclerotium (12 [hp_X]) Aconitum Napellus Atropa Belladonna Bryonia Alba Root Gelsemium Sempervirens Root Nitroglycerin Melilotus Officinalis Top Strychnos Nux-vomica Seed Sepia Officinalis Juice Spigelia Anthelmia
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2014-08-12

Description

Carduus Marianus 1X, Pyrethrum Parthenium 1X, Secale Cornutum 6X, Aconitum Napellus 12X, Belladonna 12X, Bryonia (Alba) 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Melilotus Officinalis 12X, Nux Vomica 12X, Sepia 12X, Spigelia Anthelmia 12X


Medication Information

Description

Carduus Marianus 1X, Pyrethrum Parthenium 1X, Secale Cornutum 6X, Aconitum Napellus 12X, Belladonna 12X, Bryonia (Alba) 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Melilotus Officinalis 12X, Nux Vomica 12X, Sepia 12X, Spigelia Anthelmia 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 cool, dry place.

Questions:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

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 throbbing headache with muscular soreness of neck and shoulder pain and fullness, especially in the forehead, occiput and temples, and bursting, splitting headache.

Active Ingredients:

Carduus Marianus 1X, Pyrethrum Parthenium 1X, Secale Cornutum 6X, Aconitum Napellus 12X, Belladonna 12X, Bryonia (Alba) 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Melilotus Officinalis 12X, Nux Vomica 12X, Sepia 12X, Spigelia Anthelmia 12X

Inactive Ingredients:

Demineralized water, 25% Ethanol.

Package Label Display:

BioActive Homeopathic

HEADACHE TONIC

2 FL OZ (60 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 cool, dry place.

Questions: (QUESTIONS:)

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

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 throbbing headache with muscular soreness of neck and shoulder pain and fullness, especially in the forehead, occiput and temples, and bursting, splitting headache.

Active Ingredients: (ACTIVE INGREDIENTS:)

Carduus Marianus 1X, Pyrethrum Parthenium 1X, Secale Cornutum 6X, Aconitum Napellus 12X, Belladonna 12X, Bryonia (Alba) 12X, Gelsemium Sempervirens 12X, Glonoinum 12X, Melilotus Officinalis 12X, Nux Vomica 12X, Sepia 12X, Spigelia Anthelmia 12X

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 25% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BioActive Homeopathic

HEADACHE TONIC

2 FL OZ (60 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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