Cough Syrup Formula

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2023-08-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:26:47

Label at a glance#

ProductCough Syrup Formula
Active ingredientDROSERA ROTUNDIFOLIA, PROTORTONIA CACTI, SPONGIA OFFICINALIS SKELETON, ROASTED, ATROPA BELLADONNA, CUPRIC ACETATE, POTASSIUM CARBONATE, MENTHA PIPERITA, 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) 3X, 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 and 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

Keep out of reach of children. 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 and cough with expectorations.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

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:

OTC - QUESTIONS SECTION

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioActive Homeopathic

COUGH SYRUP FORMULA

4 FL OZ (120 ml)

cough syrup formulacough syrup formula

cough syrup formulacough syrup formula

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0281-12023-08-28C16284748780-19d75b9d0-742f-f424-e053-dadaa90a57ceDRUG FACTS
43857-0281-12020-01-31C16284748780-19d75b9d0-742f-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
CUPRIC ACETATEACTIVE INGREDIENT39M11XPH031
DROSERA ROTUNDIFOLIAACTIVE INGREDIENTQR44N9XPJQ1
MENTHA PIPERITAACTIVE INGREDIENT79M2M2UDA91
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W1
POTASSIUM CARBONATEACTIVE INGREDIENTBQN1B9B9HA1
PROTORTONIA CACTIACTIVE INGREDIENTLZB7TFX1LT1
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE INGREDIENT1PIP394IID1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
CARBONATE IONACTIVE MOIETY7UJQ5OPE7D1
CUPRIC CATIONACTIVE MOIETY8CBV67279L1
DROSERA ROTUNDIFOLIAACTIVE MOIETYQR44N9XPJQ1
MENTHA PIPERITAACTIVE MOIETY79M2M2UDA91
PHOSPHORUSACTIVE MOIETY27YLU75U4W1
PROTORTONIA CACTIACTIVE MOIETYLZB7TFX1LT1
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE MOIETY1PIP394IID1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ANISEINACTIVE INGREDIENT21C2F5E8RE1
BERRYINACTIVE INGREDIENTFV3431923Z1
CETRARIA ISLANDICA SUBSP. ISLANDICAINACTIVE INGREDIENTBJ7YPN79A11
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X1
CHERRYINACTIVE INGREDIENTBUC5I9595W1
ECHINACEA ANGUSTIFOLIAINACTIVE INGREDIENTVB06AV5US81
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6621
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6S1
MALVA SYLVESTRIS FLOWERINACTIVE INGREDIENT12X9JI52BS1
PLANTAGO MAJOR LEAFINACTIVE INGREDIENT7DC28K241X1
THYMUS VULGARIS LEAFINACTIVE INGREDIENTGRX34996431
TRIFOLIUM PRATENSE FLOWERINACTIVE INGREDIENT4JS08388281
URTICA DIOICA LEAFINACTIVE INGREDIENTX6M0DRN46Q1
VERBASCUM THAPSUS LEAFINACTIVE INGREDIENTANX0EG34JE1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
43857-028143857-0281-1

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 67 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
ANISEANISE21C2F5E8REELIXIR / ORAL0.15 mg/5mlExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSOLUTION / ORAL10000 mgExact identifier — unii candidate
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
CHERRYCHERRYBUC5I9595WTABLET / ORAL0.45 mgExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
HIGH FRUCTOSE CORN SYRUPHIGH FRUCTOSE CORN SYRUPXY6UN3QB6SSUSPENSION / ORAL20000 mgExact identifier — unii candidate
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
CHERRYCHERRYBUC5I9595WTABLET, CHEWABLE / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
ANISEANISE21C2F5E8RESOLUTION / ORAL72 mgExact identifier — unii candidate
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
edf7557a-2017-45ff-9102-7ed7710d2a34639c502f-c3b3-4d56-95e1-8f5f9544d5492023-08-28WarningsExact identifier
spl id: edf7557a-2017-45ff-9102-7ed7710d2a34
spl set id: 639c502f-c3b3-4d56-95e1-8f5f9544d549

Reported adverse events (FAERS/openFDA)#

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