Tension Headache

Manufacturer
Liddell Laboratories, Inc. | Apotheca Company
Effective date
2024-07-31
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:27:41

Label at a glance#

ProductTension Headache
Active ingredientACONITUM NAPELLUS, MILK THISTLE, ARABICA COFFEE BEAN, DIOSCOREA VILLOSA TUBER, GELSEMIUM SEMPERVIRENS ROOT, PSEUDOGNAPHALIUM OBTUSIFOLIUM, IRIS VERSICOLOR ROOT, PASSIFLORA INCARNATA FLOWERING TOP, STELLARIA MEDIA, VERBASCUM THAPSUS
Label structure9 sections

Indications and uses

May temporarily relieve symptoms of tension headaches: • dull or sharp pain • neck and shoulder tension • feelings of pressure** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

Adults and children over 12 : Spray twice under the tongue up to each 30 minutes as needed. Children 12 and under : Consult a doctor prior to use.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Aconitum Napellus 200C, Carduus Marianus 3X, Coffea Cruda 200C, Dioscorea Villosa 3X, Gelsemium Sempervirens 3X, Gnaphalium Polycephalum 3X, Iris Versicolor 3X, Passiflora Incarnata 2X, Stellaria Media 3X, Verbascum Thapsus 3X.

USES:

OTC - PURPOSE SECTION

May temporarily relieve symptoms of tension headaches:

• dull or sharp pain

• neck and shoulder tension

• feelings of pressure**

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

WARNINGS:

WARNINGS SECTION

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Stop use and ask a doctor if symptoms persist, worsen or if new symptoms occur.

Keep out of reach of children. In case of overdose, get medical help or call a Poison Control Center right away.

If pregnant or breast feeding, ask a doctor before using product.

Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.

Store at room temperature.

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 call a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12: Spray twice under the tongue up to each 30 minutes as needed.

Children 12 and under: Consult a doctor prior to use.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve symptoms of tension headaches:

• dull or sharp pain

• neck and shoulder tension

• feelings of pressure**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Organic alcohol 20% v/v, Purified water

QUESTIONS:

OTC - QUESTIONS SECTION

DIST. BY

LIDDELL LABORATORIES, INC.

201 APPLE BLVD.

WOODBINE, IA 51579

www.LIDDELL.NET

1-800-460-7733

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORAL SPRAYS

LIDDELL

LABORATORIES

EST. 1994

42 TH

Tension
Headache

May relieve symptoms of tension
headaches: dull or sharp pain,
neck and shoulder tension,
feelings of pressure.

HOMEOPATHIC

DOCTOR FORMULATED
Readily absorbed. Safe.
No known side effects. Easy to use.

1.0 FL OZ (30 ml)

Tension Headache lblTension Headache lbl

Tension Headache ctnTension Headache ctn

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50845-0058-22024-07-31C16284748780-19d75b9d0-d4a1-f424-e053-dadaa90a57ceDrug Facts:
50845-0058-22024-01-30C16284748780-19d75b9d0-d4a1-f424-e053-dadaa90a57ceDrug Facts:
50845-0058-22021-12-16C16284748780-19d75b9d0-d4a1-f424-e053-dadaa90a57ceDrug Facts:
50845-0058-22020-01-31C16284748780-19d75b9d0-d4a1-f424-e053-dadaa90a57ceDrug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0058-1Tension Headache30 mL in 1 BOTTLE, SPRAYSPRAY308
50845-0058-2Tension Headache1 in 1 CARTONSPRAY18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0058TENSION HEADACHE (ACONITUM NAPELLUS, CARDUUS MARIANUS, COFFEA CRUDA, DIOSCOREA VILLOSA, GELSEMIUM SEMPERVIRENS, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, PASSIFLORA INCARNATA, STELLARIA MEDIA, VERBASCUM THAPSUS) SPRAY [LIDDELL LABORATORIES, INC.]8Legacy NDC, 2 package rows20240801_4ac40cd1-6f86-4183-a1ec-57e98bc01aa1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD4
ARABICA COFFEE BEANACTIVE INGREDIENT3SW678MX724
DIOSCOREA VILLOSA TUBERACTIVE INGREDIENTIWY3IWX2G84
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q4
IRIS VERSICOLOR ROOTACTIVE INGREDIENTX43D4L3DQC4
MILK THISTLEACTIVE INGREDIENTU946SH95EE4
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11O4
PSEUDOGNAPHALIUM OBTUSIFOLIUMACTIVE INGREDIENT36XQ854NWW4
STELLARIA MEDIAACTIVE INGREDIENT2H03479QVR4
VERBASCUM THAPSUSACTIVE INGREDIENTC9TD27U1724
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD4
ARABICA COFFEE BEANACTIVE MOIETY3SW678MX724
DIOSCOREA VILLOSA ROOTACTIVE MOIETYIWY3IWX2G84
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q4
IRIS VERSICOLOR ROOTACTIVE MOIETYX43D4L3DQC4
MILK THISTLEACTIVE MOIETYU946SH95EE4
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11O4
PSEUDOGNAPHALIUM OBTUSIFOLIUMACTIVE MOIETY36XQ854NWW4
STELLARIA MEDIAACTIVE MOIETY2H03479QVR4
VERBASCUM THAPSUSACTIVE MOIETYC9TD27U1724
ALCOHOLINACTIVE INGREDIENT3K9958V90M4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50845-005850845-0058-1, 50845-0058-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
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ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
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ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
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ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 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
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact 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
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact 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
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ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
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ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact 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
02be9339-29af-4682-967d-f48e5ef345154ac40cd1-6f86-4183-a1ec-57e98bc01aa12024-07-31WarningsExact identifier
spl id: 02be9339-29af-4682-967d-f48e5ef34515
spl set id: 4ac40cd1-6f86-4183-a1ec-57e98bc01aa1

Reported adverse events (FAERS/openFDA)#

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