COUGH SYRUP FORMULA- drosera (rotundifolia), coccus cacti, spongia tosta, belladonna, cuprum aceticum, kali carbonicum, mentha piperita, phosphorus liquid
BioActive Nutritional, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Drug Facts:

ACTIVE INGREDIENTS:

Drosera (Rotundifolia) 3X, Coccus Cacti 5X, Spongia Tosta 5X, Belladonna 6X, Cuprum Aceticum 12X, Kali Carbonicum 12X, Mentha Piperita 12X, Phosphorus 12X.

INDICATIONS:

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

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.

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.

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.

INACTIVE INGREDIENTS:

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

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY:

BioActive Homeopathic

COUGH SYRUP FORMULA

4 FL OZ (120 ml)

COUGH SYRUP FORMULA

COUGH SYRUP FORMULA
drosera (rotundifolia), coccus cacti, spongia tosta, belladonna, cuprum aceticum, kali carbonicum, mentha piperita, phosphorus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43857-0378
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DROSERA ROTUNDIFOLIA (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA - UNII:QR44N9XPJQ)	DROSERA ROTUNDIFOLIA	3 [hp_X] in 1 mL
PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT)	PROTORTONIA CACTI	5 [hp_X] in 1 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID)	SPONGIA OFFICINALIS SKELETON, ROASTED	5 [hp_X] in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X] in 1 mL
CUPRIC ACETATE (UNII: 39M11XPH03) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC ACETATE	12 [hp_X] in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D)	POTASSIUM CARBONATE	12 [hp_X] in 1 mL
MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9)	MENTHA PIPERITA	12 [hp_X] in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CHAMOMILE (UNII: FGL3685T2X)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
MALVA SYLVESTRIS FLOWER (UNII: 12X9JI52BS)
CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1)
VERBASCUM THAPSUS LEAF (UNII: ANX0EG34JE)
PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
HONEY (UNII: Y9H1V576FH)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
CHERRY (UNII: BUC5I9595W)
BERRY (UNII: FV3431923Z)
ANISE (UNII: 21C2F5E8RE)
EUCALYPTUS OIL (UNII: 2R04ONI662)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43857-0378-1	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/29/2015	01/29/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/29/2015	01/29/2023

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(43857-0378) , api manufacture(43857-0378) , label(43857-0378) , pack(43857-0378)

Revised: 11/2021

Document Id: 359423d2-179a-4494-886e-bc2aa269e514

Set id: 0ba44842-bed6-4d22-9f25-20af6b09975d

Version: 3

Effective Time: 20211130

BioActive Nutritional, Inc.