FDA.reportPublic FDA data

INFECTISTAT

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2021-12-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:20:20

Label at a glance#

ProductINFECTISTAT
Active ingredientBAPTISIA TINCTORIA ROOT, ECHINACEA ANGUSTIFOLIA, GOLDENSEAL, LOBELIA INFLATA, LOMATIUM DISSECTUM ROOT, PHYTOLACCA AMERICANA ROOT, COMFREY ROOT, SUS SCROFA LUNG, ACONITUM NAPELLUS, ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, CAUSTICUM, EUPATORIUM PERFOLIATUM FLOWERING TOP, FERROSOFERRIC PHOSPHATE, GELSEMIUM SEMPERVIRENS ROOT, HYPERICUM PERFORATUM, POTASSIUM CARBONATE, LACHESIS MUTA VENOM, SODIUM SULFATE, PHOSPHORUS, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, SULFUR, RANCID BEEF
Label structure9 sections

Dosage and administration

Adults and children 5 to 10 drops orally, 3 times a day or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

BAPTISIA TINCTORIA 3X,  ECHINACEA (ANGUSTIFOLIA) 3X,  HYDRASTIS CANADENSIS 3X,  LOBELIA INFLATA 3X,  LOMATIUM DISSECTUM 3X,  PHYTOLACCA DECANDRA 3X,  SYMPHYTUM OFFICINALE 3X,  LUNG (SUIS) 6X,  ACONITUM NAPELLUS 12X,  ARSENICUM ALBUM 12X,  BELLADONNA 12X,  BRYONIA (ALBA) 12X,  CAUSTICUM 12X,  EUPATORIUM PERFOLIATUM 12X,  FERRUM PHOSPHORICUM 12X,  GELSEMIUM SEMPERVIRENS 12X,  HYPERICUM PERFORATUM 12X,  KALI CARBONICUM 12X,  LACHESIS MUTUS 12X,  NATRUM SULPHURICUM 12X,  PHOSPHORUS 12X,  PULSATILLA (VULGARIS) 12X,  RHUS TOXICODENDRON 12X,  SILICEA 12X,  SULPHUR 12X,  PYROGENIUM 30X

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of fever, irritated throat and cough due to bacterial and viral conditions.

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health 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

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

Adults and children 5 to 10 drops orally, 3 times a day or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of fever, irritated throat and cough due to bacterial and viral conditions.

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579   800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

since 1987

HOMEOPATHIC REMEDY

INFECTISTAT

1fl. oz. (30 ml)

Infectistat 1 ozInfectistat 1 oz

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0131-12021-12-29C16284748780-19d75b9d0-66ca-f424-e053-dadaa90a57ceDRUG FACTS:
44911-0131-12020-01-31C16284748780-19d75b9d0-66ca-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
BAPTISIA TINCTORIA ROOTACTIVE INGREDIENT5EF0HWI5WU1
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B1
CAUSTICUMACTIVE INGREDIENTDD5FO1WKFU1
COMFREY ROOTACTIVE INGREDIENTM9VVZ08EKQ1
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US81
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE INGREDIENT1W0775VX6E1
FERROSOFERRIC PHOSPHATEACTIVE INGREDIENT91GQH8I5F71
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q1
GOLDENSEALACTIVE INGREDIENTZW3Z11D0JV1
HYPERICUM PERFORATUMACTIVE INGREDIENTXK4IUX8MNB1
LACHESIS MUTA VENOMACTIVE INGREDIENTVSW71SS07I1
LOBELIA INFLATAACTIVE INGREDIENT9PP1T3TC5U1
LOMATIUM DISSECTUM ROOTACTIVE INGREDIENT5329928G5N1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W1
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEG1
POTASSIUM CARBONATEACTIVE INGREDIENTBQN1B9B9HA1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
RANCID BEEFACTIVE INGREDIENT29SUH5R3HU1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21J1
SULFURACTIVE INGREDIENT70FD1KFU701
SUS SCROFA LUNGACTIVE INGREDIENT7GL3G1COB31
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A1
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD1
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
BAPTISIA TINCTORIA ROOTACTIVE MOIETY5EF0HWI5WU1
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B1
CARBONATE IONACTIVE MOIETY7UJQ5OPE7D1
CAUSTICUMACTIVE MOIETYDD5FO1WKFU1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
COMFREY ROOTACTIVE MOIETYM9VVZ08EKQ1
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US81
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE MOIETY1W0775VX6E1
FERROSOFERRIC PHOSPHATEACTIVE MOIETY91GQH8I5F71
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q1
GOLDENSEALACTIVE MOIETYZW3Z11D0JV1
HYPERICUM PERFORATUMACTIVE MOIETYXK4IUX8MNB1
LACHESIS MUTA VENOMACTIVE MOIETYVSW71SS07I1
LOBELIA INFLATAACTIVE MOIETY9PP1T3TC5U1
LOMATIUM DISSECTUM ROOTACTIVE MOIETY5329928G5N1
PHOSPHORUSACTIVE MOIETY27YLU75U4W1
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEG1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
RANCID BEEFACTIVE MOIETY29SUH5R3HU1
SODIUM SULFATE ANHYDROUSACTIVE MOIETY36KCS0R7501
SULFURACTIVE MOIETY70FD1KFU701
SUS SCROFA LUNGACTIVE MOIETY7GL3G1COB31
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-013144911-0131-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
GOLDENSEALZW3Z11D0JVACTIB
LOBELIA INFLATA9PP1T3TC5UACTIB
LOMATIUM DISSECTUM ROOT5329928G5NACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
COMFREY ROOTM9VVZ08EKQACTIB
SUS SCROFA LUNG7GL3G1COB3ACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CAUSTICUMDD5FO1WKFUACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
SODIUM SULFATE0YPR65R21JACTIB
PHOSPHORUS27YLU75U4WACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SULFUR70FD1KFU70ACTIB
RANCID BEEF29SUH5R3HUACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 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
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
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 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
2bc832bb-914b-4b81-be0a-1fd953405e50d3a87a5c-e07f-4fca-b244-a4b9f5b44efe2021-12-28WarningsExact identifier
spl id: 2bc832bb-914b-4b81-be0a-1fd953405e50
spl set id: d3a87a5c-e07f-4fca-b244-a4b9f5b44efe

Reported adverse events (FAERS/openFDA)#

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