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) 4X, 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:

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, 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.

QUESTIONS:

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0548
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DROSERA ROTUNDIFOLIA WHOLE (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA WHOLE - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA WHOLE4 [hp_X]  in 1 mL
PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI5 [hp_X]  in 1 mL
SPONGIA OFFICINALIS SKELETON, ROASTED (UNII: 1PIP394IID) (SPONGIA OFFICINALIS SKELETON, ROASTED - UNII:1PIP394IID) SPONGIA OFFICINALIS SKELETON, ROASTED5 [hp_X]  in 1 mL
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 1 mL
CUPRIC ACETATE (UNII: 39M11XPH03) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC ACETATE12 [hp_X]  in 1 mL
POTASSIUM CARBONATE (UNII: BQN1B9B9HA) (CARBONATE ION - UNII:7UJQ5OPE7D) POTASSIUM CARBONATE12 [hp_X]  in 1 mL
MENTHA X PIPERITA WHOLE (UNII: 79M2M2UDA9) (MENTHA X PIPERITA WHOLE - UNII:79M2M2UDA9) MENTHA X PIPERITA WHOLE12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS12 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CHAMOMILE (UNII: FGL3685T2X)  
ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8)  
MALVA SYLVESTRIS FLOWER (UNII: 12X9JI52BS)  
CETRARIA ISLANDICA WHOLE (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 OIL (UNII: 6Y89129C8H)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0548-1120 mL in 1 BOTTLE; Type 0: Not a Combination Product02/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/25/2020
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0548) , api manufacture(43857-0548) , label(43857-0548) , pack(43857-0548)

Revised: 1/2024
Document Id: dee49bf1-2692-4b6f-ad0b-4c76659076b6
Set id: ade129ac-3a50-47fe-87be-8efc3a64d2cd
Version: 3
Effective Time: 20240105
 
BioActive Nutritional, Inc.