Headache Pain and Sinus Pressure Relief

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2021-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:20:36

Label at a glance#

ProductHeadache Pain and Sinus Pressure Relief
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, CROTON TIGLIUM SEED, SODIUM CHLORIDE, PLANTAGO MAJOR, TOXICODENDRON PUBESCENS LEAF, SARSAPARILLA
Label structure9 sections

Dosage and administration

Adults and children spray liberally on affected area as needed. 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

CALENDULA OFFICINALIS 12X, CROTON TIGLIUM 30X, NATRUM MURIATICUM 30X, PLANTAGO MAJOR 30X, RHUS TOX 30X, SARSAPARILLA (SIMILAX REGELII) 30X

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve pain due to inflammation caused by but not limited to the following: pressure, tension, trauma.**

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

WARNINGS:

WARNINGS SECTION

For external use only.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not get into eyes.

If symptoms persist, consult a doctor.

Do not use if tamper evident seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children spray liberally on affected area as needed. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve pain due to inflammation caused by but not limited to the following: pressure, tension, trauma.**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

ALOE BARBADENSIS LEAF JUICE (ALOE VERA 10X CONCENTRATE), (FLOWER)* ARNICA MONTANA (FLOWER)*, LARREA TRIDENTATA, (LEAF)* SYMPHYTUM OFFICINALE (LEAF)*, CROTON LECHLERI(SAP), INSTANTIZED SOLUBLE EGGSHELL MEMBRANE + (BIOVADERM BRAND WITH 1% SUNFLOWER LECITHIN), LAVANDULA ANGUSTIFOLIA (BUDS)*, IONIC COLLOIDAL SILVER BASE, MELISSA OFFICINALIS (LEAF)* , PEG-33, PEG-8 DIMETHICONE, PEG-14 (SILSENSE COPOLYOL-1 SILICONE), PHENOXYETHANOL, CAPRYLYL GLYCOL, SORBIC ACID, (OPTIPHEN-PLUS), PHYTOLACCA AMERICANA (BERRIES)*, PHYTOLACCA AMERICANA (ROOT)*, POTASSIUM SORBATE, PURIFIED WATER, SODIUM BICARBONATE, HYPERICUM PERFORATUM (AERIAL PARTS)*, TOCOPHEROL [VITAMIN E OIL] (DERIVED FROM SOY BEAN), VITAMIN C POWDER (ASCORBIC ACID), WHEY PROTEIN CONCENTRATE (RRB-117), SALIX ALBA(BARK)*, ACHELLEA MILLEFOLIUM (FLOWER)*

*Extract

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

HEADACHE PAIN & SINUS PRESSURE RELIEF

Topical Spray

1 fl. oz. (30 ml)

HEADACHE PAIN & SINUS PRESSURE RELIEFHEADACHE PAIN & SINUS PRESSURE RELIEF

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0134-12021-12-28C16284748780-19d75b9d0-6631-f424-e053-dadaa90a57ceDRUG FACTS:
44911-0134-12020-01-31C16284748780-19d75b9d0-6631-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ1
CROTON TIGLIUM SEEDACTIVE INGREDIENT0HK2GZK66E1
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6U1
SARSAPARILLAACTIVE INGREDIENT2H1576D5WG1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X1
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ1
CHLORIDE IONACTIVE MOIETYQ32ZN486981
CROTON TIGLIUM SEEDACTIVE MOIETY0HK2GZK66E1
PLANTAGO MAJORACTIVE MOIETYW2469WNO6U1
SARSAPARILLAACTIVE MOIETY2H1576D5WG1
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
ACHILLEA MILLEFOLIUM FLOWERINACTIVE INGREDIENTYQR8R0SQEA1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
ARNICA MONTANA FLOWERINACTIVE INGREDIENTOZ0E5Y15PZ1
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839X1
CROTON LECHLERI RESININACTIVE INGREDIENTGGG6W25C631
EGG SHELL MEMBRANEINACTIVE INGREDIENTN7QBR4212V1
LARREA TRIDENTATA TOPINACTIVE INGREDIENTPK0TXD049P1
LAVANDULA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENT19AH1RAF4M1
LECITHIN, SUNFLOWERINACTIVE INGREDIENT834K0WOS5G1
MELISSA OFFICINALIS LEAFINACTIVE INGREDIENT50D2ZE92191
PEG-8 DIMETHICONEINACTIVE INGREDIENTGIA7T764OD1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PHYTOLACCA AMERICANA FRUITINACTIVE INGREDIENTWE636614991
PHYTOLACCA AMERICANA ROOTINACTIVE INGREDIENT11E6VI8VEG1
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33A1
POLYETHYLENE GLYCOL 700INACTIVE INGREDIENT762678AC5R1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
SALIX ALBA BARKINACTIVE INGREDIENT205MXS71H71
SILVERINACTIVE INGREDIENT3M4G523W1G1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO1
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B1
ST. JOHN'S WORTINACTIVE INGREDIENTUFH8805FKA1
WATERINACTIVE INGREDIENT059QF0KO0R1
WHEYINACTIVE INGREDIENT8617Z5FMF61

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-013444911-0134-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Source Document#

Source XML · Source PDF

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 · 119 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / SUBLINGUAL0.16 mgExact identifier — unii candidate
19 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRACAVITARY5 mgExact identifier — unii candidate
25 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BOINTMENT / TOPICAL0.1 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, FILM COATED, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, EXTENDED RELEASE / ORAL81 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
34 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2 mgExact identifier — unii candidate
25 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BEMULSION / OPHTHALMIC1 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOLOZENGE / ORAL100 mgExact identifier — unii candidate
34 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING / ORAL107 mgExact identifier — unii candidate
34 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RCONCENTRATE / ORAL6 mg/1mlExact identifier — unii candidate
25 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SPRAY, METERED / NASAL0.06 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii candidate
19 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RTABLET, ORALLY DISINTEGRATING / ORAL2.35 mgExact identifier — unii candidate
25 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSUSPENSION / ORAL520 mgExact identifier — unii candidate
25 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS160 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii candidate
19 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33AGEL / DENTAL5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / INTRATHECAL0.05 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BAEROSOL, FOAM / TOPICAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, EFFERVESCENT / ORAL57600 mgExact identifier — unii candidate
34 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4AEROSOL, FOAM / TOPICAL8 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAMUSCULAR175 mgExact identifier — unii candidate
34 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION / INTRAVENOUS1440 mgExact identifier — unii candidate
25 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / ORAL1000 mg/15mlExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, CHEWABLE / ORAL140 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSYRUP / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RAEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOCAPSULE, DELAYED RELEASE PELLETS / ORAL4 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET / ORAL10 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOPOWDER, FOR SOLUTION / ORAL1250 mg/100mlExact identifier — unii candidate
34 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, DELAYED RELEASE / ORAL30 mgExact identifier — unii candidate
34 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSYRUP / ORAL200 mgExact identifier — unii candidate
25 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAVENOUS812 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET / BUCCAL42 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS3219 mgExact identifier — unii candidate
34 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / RECTAL6.67 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4EMULSION / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, COATED / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, FILM COATED / ORAL5 mgExact identifier — unii candidate
19 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BSOLUTION / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500POLYETHYLENE GLYCOL 16001212Z7S33ATABLET / ORAL1.2 mgExact identifier — unii candidate
6 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RINJECTION, SOLUTION / INFILTRATION0.2 %w/vExact identifier — unii candidate
25 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET, COATED / ORAL10.6 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BTABLET, DELAYED RELEASE / ORAL0.03 mgExact identifier — unii candidate
19 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RGEL / TOPICAL7 mgExact identifier — unii candidate
25 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET / ORAL1300 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOINJECTION, SOLUTION / INTRAVENOUS52 mgExact identifier — unii candidate
34 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 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
e5b74524-9338-46ba-93f3-382a4b266cd9dec01daf-4fc4-403f-862f-ad17e8baa1dc2021-12-28WarningsExact identifier
spl id: e5b74524-9338-46ba-93f3-382a4b266cd9
spl set id: dec01daf-4fc4-403f-862f-ad17e8baa1dc

Reported adverse events (FAERS/openFDA)#

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