DRUG FACTS:

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2026-10-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-10-29 01:00:47

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

Indications and uses

For temporary relief of irritable, dry tickling cough, associated with flu, spasmodic cough worse at night and cough with expectorations.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

• 1 teaspoon every 2-3 hours, children under 12, ½ adult dose. • Consult physician for use under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

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

PURPOSES:

OTC - PURPOSE SECTION

Belladonna - cough,** Coccus Cacti – light cough,** Cuprum Aceticum – irritating cough,** Drosera – barking cough,** Kali Carbonicum - congestion,** Mentha Piperita - cough,** Phosphorus – hoarse, dry cough,** Spongia Tosta – dry cough**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

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

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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 a 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

• 1 teaspoon every 2-3 hours, children under 12, ½ adult dose.

• Consult physician for use under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Anise Essential Oil (Seed) Pimpinella Anisum, Chamomile (Flower) Matricaria Recutita, Demineralized Water, Echinacea Angustifolia (leaf, stem), Echinacea Angustifolia, Eucalyptus Essential Oil (Leaf) Eucalyptus Globulus, 10% Ethanol, Honey, High Mallow (Flower) Malva Sylvestris, Iceland Moss (Whole Plant) Cetraria Islandica, Mullein (Leaf) Verbascum Thapsus, Natural Cherry Flavor, Natural Mixed Berry Flavor, Plantain (Leaf) Plantago Major, Red Clover (Flower) Trifolium Pratense, Stinging Nettle (Leaf) Urtica Dioica, Thyme (Leaf) Thymus Vulgaris

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

1-800-288-9525

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioActive Homeopathic

COUGH SYRUP FORMULA

4 fl. oz. (120 mL)

COUGH SYRUP FORMULACOUGH SYRUP FORMULA

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130210184341886GTIN-13: 0210184341886
EAN-13: 0210184341886
GTIN-12: 210184341886
UPC-A: 210184341886
GTIN storage (14 digits): 00210184341886
BANI0245 Cough Syrup Formula 3-18-26.jpg

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:
43857-0548-12024-01-05C16284748780-1f386c649-ea93-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0548-12023-01-30C16284748780-1f386c649-ea93-0266-e053-dadaa90a7c1aDRUG FACTS:
43857-0548-12023-01-30C16284748780-1f386c649-ea93-0266-e053-dadaa90a7c1aDRUG FACTS:

Products#

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

DailyMed product names page 1 of 1 · 28 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 · 24 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-01-05full-release2026-06-01 02:25:19

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
dee49bf1-2692-4b6f-ad0b-4c76659076b6ade129ac-3a50-47fe-87be-8efc3a64d2cd2024-01-05WarningsExact identifier
spl set id: ade129ac-3a50-47fe-87be-8efc3a64d2cd

Reported adverse events (FAERS/openFDA)#

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