Label: TENSION HEADACHE- aconitum napellus, carduus marianus, coffea cruda, dioscorea villosa, gelsemium sempervirens, gnaphalium polycephalum, iris versicolor, passiflora incarnata, stellaria media, verbascum thapsus spray
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Contains inactivated NDC Code(s)
NDC Code(s): 50845-0058-1, 50845-0058-2 - Packager: Liddell Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated May 2, 2022
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENTS:
- USES:
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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:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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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 sprayProduct 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)
