COUGH SYRUP FORMULA- not applicable liquid

Cough Syrup Formula by

Drug Labeling and Warnings

Cough Syrup Formula by is a Homeopathic medication manufactured, distributed, or labeled by BioActive Nutritional, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 and 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 and 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)], High Fructose Corn Syrup, 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)

INGREDIENTS AND APPEARANCE

COUGH SYRUP FORMULA 
not applicable liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43857-0281
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
CHERRY (UNII: BUC5I9595W)
BERRY (UNII: FV3431923Z)
ANISE (UNII: 21C2F5E8RE)
EUCALYPTUS OIL (UNII: 2R04ONI662)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43857-0281-1	120 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/05/2014

Labeler - BioActive Nutritional, Inc. (624980496)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43857-0281) , api manufacture(43857-0281) , label(43857-0281) , pack(43857-0281)