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 
Heel Inc

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.

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Valerianaheel Oral Drop

KEEP OUT OF REACH OF CHILDREN

Keep this and all medicines out of the reach of children.

INDICATIONS AND USAGE

For the temporary relief of:


WARNINGS

If symptoms persist or worsen, a physician should be consulted. As with any drug, if you are pregnant or nursing a baby, seek the advise of a health care professional before using this product.

DOSAGE AND ADMINISTRATION

Adults and children above 11 years: 10 drops orally, 3 times daily, or as directed by a physician. Consult a physician for use in children under 12 years of age.

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

Inactive ingredients: Ethanol, Purified Water USP.

PURPOSE

Sleeplessness, Restlessness, Nervous tension and exhaustion

Valerianaheel Oral Drop.jpg



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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50114-1165
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN2 [hp_X]  in 50 mL
TRINITROPHENOL (UNII: A49OS0F91S) (TRINITROPHENOL - UNII:A49OS0F91S) TRINITROPHENOL6 [hp_X]  in 50 mL
PRUNUS SPINOSA FLOWER BUD (UNII: 53Y84VPS2W) (PRUNUS SPINOSA FLOWER BUD - UNII:53Y84VPS2W) PRUNUS SPINOSA FLOWER BUD2 [hp_X]  in 50 mL
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS2 [hp_X]  in 50 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM3 [hp_X]  in 50 mL
MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS2 [hp_X]  in 50 mL
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP2 [hp_X]  in 50 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA2 [hp_X]  in 50 mL
AMMONIUM BROMIDE (UNII: R0JB3224WS) (AMMONIUM BROMIDE - UNII:R0JB3224WS) AMMONIUM BROMIDE2 [hp_X]  in 50 mL
POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06, POTASSIUM CATION - UNII:295O53K152) POTASSIUM BROMIDE2 mm  in 50 mL
SODIUM BROMIDE (UNII: LC1V549NOM) (SODIUM CATION - UNII:LYR4M0NH37, BROMIDE ION - UNII:952902IX06) SODIUM BROMIDE2 [hp_X]  in 50 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-1165-450 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/1986
Labeler - Heel Inc (102783016)
Establishment
NameAddressID/FEIBusiness Operations
Heel Inc102783016manufacture

Revised: 2/2012
Document Id: 9f8cf8e1-df0f-43c5-ad97-f3ae07f5c127
Set id: 89c84354-e423-415c-bb31-dba20e4cc95f
Version: 1
Effective Time: 20120220
 
Heel Inc