DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

D3 ORGAN SUPPORT- conium maculatum, dulcamara, echinacea, aesculus hippocastanum, antimonium tartaricum, ascorbic acid, coccus cacti, galium aparine, gentiana lutea, geranium robertianum, pulsatilla (vulgaris), sarcolacticum acidum, lymph (suis), sulphur, glandula suprarenalis suis, phenylalanine, calcarea phosphorica, ferrum phosphoricum, hepar suis, hypothalamus (suis), spleen (suis), cortisone aceticum, mercurius solubilis, baryta carbonica, funiculus umbilicalis suis, tonsil (suis), gaertner bacillus (bach) liquid 
Restivo Chiropractic

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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DRUG FACTS

ACTIVE INGREDIENTS:

Conium Maculatum 4X, Dulcamara 4X, Echinacea 4X, Aesculus Hippocastanum 6X, Antimonium Tartaricum 6X, Ascorbic Acid 6X, Coccus Cacti 6X, Galium Aparine 6X, Gentiana Lutea 6X, Geranium Robertianum 6X, Pulsatilla (Vulgaris) 6X, Sarcolacticum Acidum 6X, Lymph (suis) 8X, Sulphur 8X, Glandula Suprarenalis Suis 8X, Phenylalanine 8X, Calcarea Phosphorica 10X, Ferrum Phosphoricum 10X, Hepar Suis 10X, Hypothalamus (suis) 10X, Spleen (suis) 10X, Cortisone Aceticum 13X, Mercurius Solubilis 13X, Baryta Carbonica 28X, Funiculus Umbilicalis Suis 6C, 30C, Tonsil (suis) 6C, 30C, Gaertner Bacillus (Bach) 9C, Triiodothyronine 10C, Medulla Ossis Suis 12C, Bisphenol A (BPA) 12C, 30C, 200C, 1000C, Bromium 12C, 30C, 200C, 1000C, Chlorinum 12C, 30C, 200C, 1000C, Hydrofluoricum Acidum 12C, 30C, 200C, 1000C, Iodium 12C, 30C, 200C, 1000C, Mutabile Bacillus (Bach) 30C

INDICATIONS:

For temporary relief of symptoms related to improper breakdown and excretion of allergenic substances, including chronic pain, fatigue, cramping and upper respiratory allergy.

WARNINGS

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

If pregnant or breast-feeding, ask a health professional before use.

Tamper seal: Sealed for your protection. Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS:

10 drops under the tongue, 3 to 6 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

INDICATIONS:

For temporary relief of symptoms related to improper breakdown and excretion of allergenic substances, including chronic pain, fatigue, cramping and upper respiratory allergy.

INACTIVE INGREDIENTS

Demineralized water, 25% Ethanol.

QUESTIONS:

Distributed by Restivo Chiropractic

822 South Lake Blvd. Mahopac, New York 10541

www.mahopacmassage.com

PACKAGE LABEL DISPLAY:

NDC: 61062-0003-1

HOMEOPATHIC

D3 ORGAN SUPPORT

1 FL OZ (30ml)

D3 Organ Support

D3 ORGAN SUPPORT 
conium maculatum, dulcamara, echinacea, aesculus hippocastanum, antimonium tartaricum, ascorbic acid, coccus cacti, galium aparine, gentiana lutea, geranium robertianum, pulsatilla (vulgaris), sarcolacticum acidum, lymph (suis), sulphur, glandula suprarenalis suis, phenylalanine, calcarea phosphorica, ferrum phosphoricum, hepar suis, hypothalamus (suis), spleen (suis), cortisone aceticum, mercurius solubilis, baryta carbonica, funiculus umbilicalis suis, tonsil (suis), gaertner bacillus (bach) liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 61062-0003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CONIUM MACULATUM FLOWERING TOP (UNII: Q28R5GF371) (CONIUM MACULATUM FLOWERING TOP - UNII:Q28R5GF371) CONIUM MACULATUM FLOWERING TOP4 [hp_X]  in 1 mL
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP4 [hp_X]  in 1 mL
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA4 [hp_X]  in 1 mL
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT6 [hp_X]  in 1 mL
ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE6 [hp_X]  in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID6 [hp_X]  in 1 mL
PROTORTONIA CACTI (UNII: LZB7TFX1LT) (PROTORTONIA CACTI - UNII:LZB7TFX1LT) PROTORTONIA CACTI6 [hp_X]  in 1 mL
GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488) GALIUM APARINE6 [hp_X]  in 1 mL
GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS) GENTIANA LUTEA ROOT6 [hp_X]  in 1 mL
GERANIUM ROBERTIANUM (UNII: R5I1HK0UBL) (GERANIUM ROBERTIANUM - UNII:R5I1HK0UBL) GERANIUM ROBERTIANUM6 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]  in 1 mL
LACTIC ACID, L- (UNII: F9S9FFU82N) (LACTIC ACID, L- - UNII:F9S9FFU82N) LACTIC ACID, L-6 [hp_X]  in 1 mL
SUS SCROFA LYMPH (UNII: 33A7VYU29L) (SUS SCROFA LYMPH - UNII:33A7VYU29L) SUS SCROFA LYMPH8 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR8 [hp_X]  in 1 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND8 [hp_X]  in 1 mL
PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R) PHENYLALANINE8 [hp_X]  in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION10 [hp_X]  in 1 mL
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE10 [hp_X]  in 1 mL
PORK LIVER (UNII: 6EC706HI7F) (PORK LIVER - UNII:6EC706HI7F) PORK LIVER10 [hp_X]  in 1 mL
SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79) SUS SCROFA HYPOTHALAMUS10 [hp_X]  in 1 mL
SUS SCROFA SPLEEN (UNII: 92AMN5J79Y) (SUS SCROFA SPLEEN - UNII:92AMN5J79Y) SUS SCROFA SPLEEN10 [hp_X]  in 1 mL
CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE13 [hp_X]  in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2) MERCURIUS SOLUBILIS13 [hp_X]  in 1 mL
BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN) BARIUM CARBONATE28 [hp_X]  in 1 mL
SUS SCROFA UMBILICAL CORD (UNII: 118OYG6W3H) (SUS SCROFA UMBILICAL CORD - UNII:118OYG6W3H) SUS SCROFA UMBILICAL CORD6 [hp_C]  in 1 mL
SUS SCROFA TONSIL (UNII: TB08NIC03W) (SUS SCROFA TONSIL - UNII:TB08NIC03W) SUS SCROFA TONSIL6 [hp_C]  in 1 mL
SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS (UNII: Y3V16D4PV4) (SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS - UNII:Y3V16D4PV4) SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS9 [hp_C]  in 1 mL
LIOTHYRONINE (UNII: 06LU7C9H1V) (LIOTHYRONINE - UNII:06LU7C9H1V) LIOTHYRONINE10 [hp_C]  in 1 mL
SUS SCROFA BONE MARROW (UNII: VP2CN2G7Y8) (SUS SCROFA BONE MARROW - UNII:VP2CN2G7Y8) SUS SCROFA BONE MARROW12 [hp_C]  in 1 mL
BISPHENOL A (UNII: MLT3645I99) (BISPHENOL A - UNII:MLT3645I99) BISPHENOL A12 [hp_C]  in 1 mL
BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE12 [hp_C]  in 1 mL
CHLORINE (UNII: 4R7X1O2820) (CHLORINE - UNII:4R7X1O2820) CHLORINE12 [hp_C]  in 1 mL
HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION12 [hp_C]  in 1 mL
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE12 [hp_C]  in 1 mL
ESCHERICHIA COLI (UNII: 514B9K0L10) (ESCHERICHIA COLI - UNII:514B9K0L10) ESCHERICHIA COLI30 [hp_C]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61062-0003-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/06/201407/01/2019
Labeler - Restivo Chiropractic (859048811)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(61062-0003) , api manufacture(61062-0003) , label(61062-0003) , pack(61062-0003)

Revised: 2/2016
Document Id: a4fa60ea-66e9-4295-acbd-7fb1fb10590a
Set id: 7d666dd4-24cb-493b-bd00-cc23d417f4b2
Version: 2
Effective Time: 20160223
 
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