Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID ade129ac-3a50-47fe-87be-8efc3a64d2cd
Route
ORAL
Published
Effective Date 2024-01-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Drosera Rotundifolia Whole (4 [hp_X]) Protortonia Cacti (5 [hp_X]) Spongia Officinalis Skeleton, Roasted (6 [hp_X]) Atropa Belladonna (12 [hp_X]) Cupric Cation Carbonate Ion Mentha X Piperita Whole Phosphorus
Inactive Ingredients
Chamomile Echinacea Angustifolia Leaf Malva Sylvestris Flower Cetraria Islandica Whole Verbascum Thapsus Leaf Plantago Major Leaf Trifolium Pratense Flower Urtica Dioica Leaf Thymus Vulgaris Leaf Honey Water Alcohol Cherry Berry Anise Oil Eucalyptus Oil Dextrose, Unspecified Form Maltodextrin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-02-25

Description

Drosera (Rotundifolia) 4X, Coccus Cacti 5X, Spongia Tosta 5X, Belladonna 6X, Cuprum Aceticum 12X, Kali Carbonicum 12X, Mentha Piperita 12X, Phosphorus 12X.


Medication Information

Description

Drosera (Rotundifolia) 4X, Coccus Cacti 5X, Spongia Tosta 5X, Belladonna 6X, Cuprum Aceticum 12X, Kali Carbonicum 12X, Mentha Piperita 12X, Phosphorus 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, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions:

SHAKE WELL.

1 teaspoon every 2-3 hours, children under 12, 1/2 adult dose.

Consult a physician for use in children under 12 years of age.

Indications:

For temporary relief of irritable, dry, tickling cough associated with flu, spasmodic cough worse at night & cough with expectorations.

Active Ingredients:

Drosera (Rotundifolia) 4X, Coccus Cacti 5X, Spongia Tosta 5X, Belladonna 6X, Cuprum Aceticum 12X, Kali Carbonicum 12X, Mentha Piperita 12X, Phosphorus 12X.

Inactive Ingredients:

Demineralized Water, Dextrose, Essential Oil Blend [Anise (Seed), Eucalyptus (Leaf)], Ethanol, 10% Herbal Extracts [Chamomile (Flower), Echinacea Angustifolia (leaf, stem), High Mallow (Flower), Iceland Moss (Whole Plant), Mullein (Leaf), Plantain (Leaf), Red Clover (Flower), Stinging Nettle (Leaf), Thyme (Leaf)], Honey, Natural Cherry Flavor, Natural Mixed Berry Flavor.

Package Label Display:

BioActive Homeopathic

COUGH SYRUP FORMULA

4 FL OZ (120 ml)

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, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

Directions: (DIRECTIONS:)

SHAKE WELL.

1 teaspoon every 2-3 hours, children under 12, 1/2 adult dose.

Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

For temporary relief of irritable, dry, tickling cough associated with flu, spasmodic cough worse at night & cough with expectorations.

Active Ingredients: (ACTIVE INGREDIENTS:)

Drosera (Rotundifolia) 4X, Coccus Cacti 5X, Spongia Tosta 5X, Belladonna 6X, Cuprum Aceticum 12X, Kali Carbonicum 12X, Mentha Piperita 12X, Phosphorus 12X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized Water, Dextrose, Essential Oil Blend [Anise (Seed), Eucalyptus (Leaf)], Ethanol, 10% Herbal Extracts [Chamomile (Flower), Echinacea Angustifolia (leaf, stem), High Mallow (Flower), Iceland Moss (Whole Plant), Mullein (Leaf), Plantain (Leaf), Red Clover (Flower), Stinging Nettle (Leaf), Thyme (Leaf)], Honey, Natural Cherry Flavor, Natural Mixed Berry Flavor.

Package Label Display: (PACKAGE LABEL DISPLAY:)

BioActive Homeopathic

COUGH SYRUP FORMULA

4 FL OZ (120 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.


Advanced Ingredient Data


Raw Label Data

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