Label: COUGH SYRUP FORMULA (drosera- rotundifolia, coccus cacti, spongia tosta, belladonna, cuprum aceticum, kali carbonicum, mentha piperita, phosphorus liquid
- NDC Code(s): 43857-0548-1
- Packager: BioActive Nutritional, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated January 5, 2024
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- ACTIVE INGREDIENTS:
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
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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.
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INGREDIENTS AND APPEARANCE
COUGH SYRUP FORMULA
drosera (rotundifolia), coccus cacti, spongia tosta, belladonna, cuprum aceticum, kali carbonicum, mentha piperita, phosphorus liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0548 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DROSERA ROTUNDIFOLIA WHOLE (UNII: QR44N9XPJQ) (DROSERA ROTUNDIFOLIA WHOLE - UNII:QR44N9XPJQ) DROSERA ROTUNDIFOLIA WHOLE 4 [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 X PIPERITA WHOLE (UNII: 79M2M2UDA9) (MENTHA X PIPERITA WHOLE - UNII:79M2M2UDA9) MENTHA X PIPERITA WHOLE 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:43857-0548-1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/25/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/25/2020 Labeler - BioActive Nutritional, Inc. (624980496) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43857-0548) , api manufacture(43857-0548) , label(43857-0548) , pack(43857-0548)
