OVARIUM COMPOSITUM - aquilegia vulgaris, goldenseal, lilium lancifolium whole flowering, lycoperdon utriforme fruiting body, cypripedium parvifolum root, ipecac, apis mellifera venom, wood creosote, sus scrofa ovary, aconitic acid, (z)-, lachesis muta venom, magnesium phosphate, dibasic trihydrate, mercurius solubilis, sus scrofa placenta, sus scrofa fallopian tube, sepia officinalis juice, sus scrofa uterus, sus scrofa pituitary gland and pulsatilla vulgaris solution 
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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Ovarium compositum Oral Vial

DESCRIPTION

Ingredients Each 2.2 ml ampule contains:Apis venenum purum 8x, Aquilegia vulgaris 4X, Bovista 6X, cis-Aconiticum acidum 10X, Cypripedium pubescens 6X, Hydrastis canadensis 4X, Hypophysis suis 13X, Ipecacuanha 6X, Kreosotum 8X, Lachesis mutus 10X, Lillium tigrinum 4X, Magnesia phosphorica 10X, Mercurius solubilis 10X, Oophorinum 8X, Placenta suis 10X, Pulsatilla 18X, Salpinx suis 10X, Sepia 10X, Uterus suis 10X 22mcl each in a Isotonic sodium chloride solution base.

INDICATION AND USAGE

Ovarium compositum® Oral Vials is a homeopathic drug product indicated for the temporary relief of symptoms associated with dysmenorrhea: pain, nervous irritability, sleeplessness and irregular menses.

DOSAGE AND ADMINISTRATION

Dosage:

Adults and children above 6 years: 1 vial orally 1-3 times daily

Children up to 6 years: ½ vial orally 1-3 times daily

CONTRAINDICATIONS

Ovarium compositum® Oral Vials are contraindicated in patients with known hypersensitivity to Ovariumcompositum® or any of its ingredients

WARNINGS AND PRECAUTIONS

Warnings and Precautions

None

ADVERSE REACTIONS

No adverse events have been reported with a causal relationship to Ovarium compositum® Oral Vials.

OVERDOSAGE

Overdosage: No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions

CLINICAL PHARMACOLOGY

Mechanism of Action

The exact mechanism of Ovarium compositum® Oral Vials is not fully understood.

Pharmacodynamics

Not applicable for homeopathic medicinal products.

DOSAGE

1 oral vial containing 2.2 ml solution for oral administration




Ovarium compositum Oral Vial.jpg

OVARIUM COMPOSITUM 
aquilegia vulgaris, goldenseal, lilium lancifolium whole flowering, lycoperdon utriforme fruiting body,cypripedium parvifolum root, ipecac, apis mellifera venom, wood sus scrofa ovary,aconitic acid, (z)-,lachesis muta venom,magnesium phosphate, dibasic trihydrate,mercurius solubilis,sus scrofa placenta,sepia officinalis juice,, sus scrofa uterus,sus scrofa pituitary gland and pulsatilla vulgaris solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:50114-5290
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AQUILEGIA VULGARIS (AQUILEGIA VULGARIS) AQUILEGIA VULGARIS4 [hp_X]  in 2.2 mL
GOLDENSEAL (GOLDENSEAL) GOLDENSEAL4 [hp_X]  in 2.2 mL
LILIUM LANCIFOLIUM WHOLE FLOWERING (LILIUM LANCIFOLIUM WHOLE FLOWERING) LILIUM LANCIFOLIUM WHOLE FLOWERING4 [hp_X]  in 2.2 mL
LYCOPERDON UTRIFORME FRUITING BODY (CYPRIPEDIUM PARVIFOLUM ROOT) LYCOPERDON UTRIFORME FRUITING BODY6 [hp_X]  in 2.2 mL
CYPRIPEDIUM PARVIFOLUM ROOT (CYPRIPEDIUM PARVIFOLUM ROOT) CYPRIPEDIUM PARVIFOLUM ROOT6 [hp_X]  in 2.2 mL
IPECAC (IPECAC) IPECAC6 [hp_X]  in 2.2 mL
APIS MELLIFERA VENOM (APIS MELLIFERA VENOM) APIS MELLIFERA VENOM8 [hp_X]  in 2.2 mL
WOOD CREOSOTE (WOOD CREOSOTE) WOOD CREOSOTE8 [hp_X]  in 2.2 mL
SUS SCROFA OVARY (SUS SCROFA OVARY) SUS SCROFA OVARY8 [hp_X]  in 2.2 mL
ACONITIC ACID, (Z)- (ACONITIC ACID, (Z)-) ACONITIC ACID, (Z)-10 [hp_X]  in 2.2 mL
LACHESIS MUTA VENOM (LACHESIS MUTA VENOM) LACHESIS MUTA VENOM10 [hp_X]  in 2.2 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE10 [hp_X]  in 2.2 mL
MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS10 [hp_X]  in 2.2 mL
SUS SCROFA PLACENTA (SUS SCROFA PLACENTA) SUS SCROFA PLACENTA10 [hp_X]  in 2.2 mL
SUS SCROFA FALLOPIAN TUBE (SUS SCROFA FALLOPIAN TUBE) SUS SCROFA FALLOPIAN TUBE10 [hp_X]  in 2.2 mL
SEPIA OFFICINALIS JUICE (SEPIA OFFICINALIS JUICE) SEPIA OFFICINALIS JUICE10 [hp_X]  in 2.2 mL
SUS SCROFA UTERUS (SUS SCROFA UTERUS) SUS SCROFA UTERUS10 [hp_X]  in 2.2 mL
SUS SCROFA PITUITARY GLAND (SUS SCROFA PITUITARY GLAND) SUS SCROFA PITUITARY GLAND13 [hp_X]  in 2.2 mL
PULSATILLA VULGARIS (PULSATILLA VULGARIS) PULSATILLA VULGARIS18 [hp_X]  in 2.2 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-5290-610 in 1 CARTON
11.1 mL in 1 AMPULE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/31/199308/14/2014
Labeler - Heel Inc (102783016)

Revised: 12/2013
Document Id: ad1ddfc8-2020-4ed7-924c-c88b43683da6
Set id: 710a8f16-fca7-4f29-af21-1686390f9e54
Version: 2
Effective Time: 20131216
 
Heel Inc