TENSION HEADACHE- aconitum napellus, carduus marianus, coffea cruda, dioscorea villosa, gelsemium sempervirens, gnaphalium polycephalum, iris versicolor, passiflora incarnata, stellaria media, verbascum thapsus spray

Tension Headache by

Drug Labeling and Warnings

Tension Headache by is a Homeopathic medication manufactured, distributed, or labeled by Liddell Laboratories, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

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:

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:

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:

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

DIRECTIONS:

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:

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:

Organic alcohol 20% v/v, Purified water

QUESTIONS:

DIST. BY

LIDDELL LABORATORIES, INC.

201 APPLE BLVD.

WOODBINE, IA 51579

WWW.LIDDELL.NET

1-800-460-7733

PACKAGE LABEL DISPLAY:

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)

INGREDIENTS AND APPEARANCE

TENSION HEADACHE 
aconitum napellus, carduus marianus, coffea cruda, dioscorea villosa, gelsemium sempervirens, gnaphalium polycephalum, iris versicolor, passiflora incarnata, stellaria media, verbascum thapsus spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50845-0058
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	200 [hp_C]  in 1 mL
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	3 [hp_X]  in 1 mL
ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72)	ARABICA COFFEE BEAN	200 [hp_C]  in 1 mL
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA ROOT - UNII:IWY3IWX2G8)	DIOSCOREA VILLOSA TUBER	3 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	3 [hp_X]  in 1 mL
PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW)	PSEUDOGNAPHALIUM OBTUSIFOLIUM	3 [hp_X]  in 1 mL
IRIS VERSICOLOR ROOT (UNII: X43D4L3DQC) (IRIS VERSICOLOR ROOT - UNII:X43D4L3DQC)	IRIS VERSICOLOR ROOT	3 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	2 [hp_X]  in 1 mL
STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR)	STELLARIA MEDIA	3 [hp_X]  in 1 mL
VERBASCUM THAPSUS (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172)	VERBASCUM THAPSUS	3 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50845-0058-2	1 in 1 CARTON	06/02/2014
1	NDC: 50845-0058-1	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/02/2014

Labeler - Liddell Laboratories, Inc. (832264241)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(50845-0058) , api manufacture(50845-0058) , label(50845-0058) , pack(50845-0058)