Label: VALERIANAHEEL- valerian and trinitrophenol and prunus spinosa flower bud and hops and hypericum perforatum and melissa officinalis and avena sativa flowering top and matricaria recutita and ammonium bromide and potassium bromide and sodium bromide liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 50114-1165-4 - Packager: Heel 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 February 20, 2012
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- INDICATIONS AND USAGE
- WARNINGS
- DOSAGE AND ADMINISTRATION
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ACTIVE INGREDIENT
Each 50 ml contains as active ingredients: Valeriana officinalis 2X 32.5 ml; Picricum acidum 6X 5 ml; Prunus spinosa 2X 2.5 ml; Humulus lupulus 2X 2.5 ml; Hypericum perforatum 3X 2.5 ml; Melissa officinalis 2X 1.5 ml; Avena sativa 2X 1 ml; Chamomilla 2X 1 ml; Ammonium bromatum 2X 0.5 ml; Kali bromatum 2X 0.5 ml; Natrum bromatum 2X 0.5 ml.
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
VALERIANAHEEL
valerian and trinitrophenol and prunus spinosa flower bud and hops and hypericum perforatum and melissa officinalis and avena sativa flowering top and matricaria recutita and ammonium bromide and potassium bromide and sodium bromide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50114-1165 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 2 [hp_X] in 50 mL TRINITROPHENOL (UNII: A49OS0F91S) (TRINITROPHENOL - UNII:A49OS0F91S) TRINITROPHENOL 6 [hp_X] in 50 mL PRUNUS SPINOSA FLOWER BUD (UNII: 53Y84VPS2W) (PRUNUS SPINOSA FLOWER BUD - UNII:53Y84VPS2W) PRUNUS SPINOSA FLOWER BUD 2 [hp_X] in 50 mL HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS 2 [hp_X] in 50 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 3 [hp_X] in 50 mL MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS 2 [hp_X] in 50 mL AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 2 [hp_X] in 50 mL MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 2 [hp_X] in 50 mL AMMONIUM BROMIDE (UNII: R0JB3224WS) (AMMONIUM BROMIDE - UNII:R0JB3224WS) AMMONIUM BROMIDE 2 [hp_X] in 50 mL POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06, POTASSIUM CATION - UNII:295O53K152) POTASSIUM BROMIDE 2 mm in 50 mL SODIUM BROMIDE (UNII: LC1V549NOM) (SODIUM CATION - UNII:LYR4M0NH37, BROMIDE ION - UNII:952902IX06) SODIUM BROMIDE 2 [hp_X] in 50 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50114-1165-4 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/31/1986 Labeler - Heel Inc (102783016) Establishment Name Address ID/FEI Business Operations Heel Inc 102783016 manufacture