FDA.reportPublic FDA data

Allerstat

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2021-12-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 22:24:05

Label at a glance#

ProductAllerstat II
Active ingredientBAPTISIA TINCTORIA ROOT, ECHINACEA, UNSPECIFIED, ONION, AMBROSIA ARTEMISIIFOLIA, ARSENIC TRIOXIDE, EUPHRASIA STRICTA, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS:  Baptisia tinctoria 3X, Echinacea 3X, Allium cepa 12X, Ambrosia artemisiaefolia 12X, Arsenicum album 12X, Euphrasia officinalis 12X, Natrum sulphuricum 12X, Nux vomica 12X, Phosphorus 12X, Pulsatilla 12X, Solidago virgaurea 12X, Sulphur 12X.

OTC - PURPOSE SECTION

INDICATIONS:  For temporary relief of sinus congestion due to hay fever and allergic rhinitis. **

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

WARNINGS SECTION

WARNINGS: 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.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS:  Adults and children 5 to 10 drops orally, 3 times daily 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.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Demineralized water, 20% Ethanol.

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.

OTC - QUESTIONS SECTION

​

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579

800-869-8078

INDICATIONS & USAGE SECTION

INDICATIONS:  For temporary relief of sinus congestion due to hay fever and allergic rhinitis. **

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​ENERGIQUE

since 1987

HOMEOPATHIC REMEDY

ALLERSTAT II

​2 fl. oz. (60 ml)

Allerstat IIAllerstat II

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0015-12021-12-08C16284748780-19d75b9d1-0864-f424-e053-dadaa90a57ceAllerstat II
44911-0015-12020-01-31C16284748780-19d75b9d1-0864-f424-e053-dadaa90a57ceAllerstat II

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AMBROSIA ARTEMISIIFOLIAACTIVE INGREDIENT9W34L2CQ9A4
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO4
BAPTISIA TINCTORIA ROOTACTIVE INGREDIENT5EF0HWI5WU4
ECHINACEA, UNSPECIFIEDACTIVE INGREDIENT4N9P6CC1DX4
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WL4
ONIONACTIVE INGREDIENT492225Q21H4
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W4
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV4
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21J4
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE INGREDIENT5405K23S504
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139194
SULFURACTIVE INGREDIENT70FD1KFU704
AMBROSIA ARTEMISIIFOLIAACTIVE MOIETY9W34L2CQ9A4
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV4
BAPTISIA TINCTORIA ROOTACTIVE MOIETY5EF0HWI5WU4
ECHINACEA, UNSPECIFIEDACTIVE MOIETY4N9P6CC1DX4
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WL4
ONIONACTIVE MOIETY492225Q21H4
PHOSPHORUSACTIVE MOIETY27YLU75U4W4
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV4
SODIUM SULFATE ANHYDROUSACTIVE MOIETY36KCS0R7504
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE MOIETY5405K23S504
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139194
SULFURACTIVE MOIETY70FD1KFU704
ALCOHOLINACTIVE INGREDIENT3K9958V90M4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-001544911-0015-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
ONION492225Q21HACTIB
AMBROSIA ARTEMISIIFOLIA9W34L2CQ9AACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
SODIUM SULFATE0YPR65R21JACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
SULFUR70FD1KFU70ACTIB
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
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact 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
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact 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
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact 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
043f4ec2-9748-4275-aaae-b08a35c0f48761910c2e-9b32-467a-af23-4ccba000b6a22021-12-08WarningsExact identifier
spl id: 043f4ec2-9748-4275-aaae-b08a35c0f487
spl set id: 61910c2e-9b32-467a-af23-4ccba000b6a2

Reported adverse events (FAERS/openFDA)#

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