FDA.reportPublic FDA data

Cough Syrup Formula

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2024-01-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:25:19

Label at a glance#

ProductCough Syrup Formula
Active ingredientDROSERA ROTUNDIFOLIA WHOLE, PROTORTONIA CACTI, SPONGIA OFFICINALIS SKELETON, ROASTED, ATROPA BELLADONNA, CUPRIC ACETATE, POTASSIUM CARBONATE, MENTHA X PIPERITA WHOLE, PHOSPHORUS
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

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

INDICATIONS:

OTC - PURPOSE SECTION

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

WARNINGS:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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 & USAGE SECTION

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

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:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioActive Homeopathic

COUGH SYRUP FORMULA

4 FL OZ (120 ml)

COUGH SYRUP FORMULACOUGH SYRUP FORMULA

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0548-12024-01-05C16284748780-1f386c649-ea93-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0548-12023-01-30C16284748780-1f386c649-ea93-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0548-1Cough Syrup Formula120 mL in 1 BOTTLELIQUID1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0548COUGH SYRUP FORMULA (DROSERA (ROTUNDIFOLIA), COCCUS CACTI, SPONGIA TOSTA, BELLADONNA, CUPRUM ACETICUM, KALI CARBONICUM, MENTHA PIPERITA, PHOSPHORUS) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20240106_ade129ac-3a50-47fe-87be-8efc3a64d2cd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-054843857-0548-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
DROSERA ROTUNDIFOLIA WHOLEQR44N9XPJQACTIB
PROTORTONIA CACTILZB7TFX1LTACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CUPRIC ACETATE39M11XPH03ACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
MENTHA X PIPERITA WHOLE79M2M2UDA9ACTIB
PHOSPHORUS27YLU75U4WACTIB
CHAMOMILEFGL3685T2XIACT
ECHINACEA ANGUSTIFOLIA LEAFFS7G8S6PJ8IACT
MALVA SYLVESTRIS FLOWER12X9JI52BSIACT
CETRARIA ISLANDICA WHOLEBJ7YPN79A1IACT
VERBASCUM THAPSUS LEAFANX0EG34JEIACT
PLANTAGO MAJOR LEAF7DC28K241XIACT
TRIFOLIUM PRATENSE FLOWER4JS0838828IACT
URTICA DIOICA LEAFX6M0DRN46QIACT
THYMUS VULGARIS LEAFGRX3499643IACT
HONEYY9H1V576FHIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
CHERRYBUC5I9595WIACT
BERRYFV3431923ZIACT
ANISE OIL6Y89129C8HIACT
EUCALYPTUS OIL2R04ONI662IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
MALTODEXTRIN7CVR7L4A2DIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough Syrup FormulaDROSERA (ROTUNDIFOLIA), COCCUS CACTI, SPONGIA TOSTA, BELLADONNA, CUPRUM ACETICUM, KALI CARBONICUM, MENTHA PIPERITA, PHOSPHORUSBioActive Nutritional, Inc.ade129ac-3a50-47fe-87be-8efc3a64d2cd2024-01-05WarningsExact identifier
ndc (package): 43857-0548-1
ndc (product): 43857-0548
ndc11 (package): 43857054801
spl id: dee49bf1-2692-4b6f-ad0b-4c76659076b6
spl set id: ade129ac-3a50-47fe-87be-8efc3a64d2cd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.