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NDC 60986-1008-03 Cholenest 2; 1; 8; 1; 8; 2; 1; 6; 1; 2 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL Details

Cholenest 2; 1; 8; 1; 8; 2; 1; 6; 1; 2 [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL

Cholenest is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Marco Pharma International LLC.. The primary component is BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; COPPER; FRANGULA PURSHIANA BARK; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MORELLA CERIFERA ROOT BARK; SILYBUM MARIANUM SEED; SODIUM SULFATE; TARAXACUM OFFICINALE; VERONICASTRUM VIRGINICUM ROOT.

Product Information

NDC	60986-1008
Product ID	60986-1008_d2bfd2b8-d3b7-e3bf-e053-2995a90a2901
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Cholenest
Proprietary Name Suffix	n/a
Non-Proprietary Name	Rhamnus purshiana, Carduus marianus, Taraxacum officinale, Chelidonium majus, Leptandra virginica, Myrica cerifera, Berberis vulgaris, Natrum sulphuricum, Magnesia phosphorica, Cuprum metallicum
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	2; 1; 8; 1; 8; 2; 1; 6; 1; 2
Active Ingredient Units	[hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL; [hp_X]/100mL
Substance Name	BERBERIS VULGARIS ROOT BARK; CHELIDONIUM MAJUS; COPPER; FRANGULA PURSHIANA BARK; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; MORELLA CERIFERA ROOT BARK; SILYBUM MARIANUM SEED; SODIUM SULFATE; TARAXACUM OFFICINALE; VERONICASTRUM VIRGINICUM ROOT
Labeler Name	Marco Pharma International LLC.
Pharmaceutical Class	Calculi Dissolution Agent [EPC], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibit Ov
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 60986-1008-03 (60986100803)

Pricing Information	N/A
NDC Package Code	60986-1008-3
Billing NDC	60986100803
Package	50 mL in 1 BOTTLE, GLASS (60986-1008-3)
Marketing Start Date	2018-02-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 4b89ffcb-318b-416d-b13c-19fb94c2af70 Details

Active Ingredients

Cascara sagrada 1xHPUS

Milk thistle 1xHPUS

Dandelion 1xHPUS

Celadine 1xHPUS

Culver's root 2xHPUS

Bayberry 2xHPUS

Barberry 2xHPUS

Disodium sulfate 6xHPUS

Magnesium hydrogen phosphate 8xHPUS

Metallic copper 8XHPUS

The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United Sates.

Purpose

Relief of constipation, difficulty digesting fat.

Keep out of reach of children.

Suggested use

Adults: 30-40 drops in tepid water 3 times daily before meals. Children, 10 drops in tepid water 3 times daily before meals.

Warnings

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

(Read Suggested Use Section)

Inactive Ingredients

Ethyl Alcohol (63.3% by vol.) and Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHOLENEST

rhamnus purshiana, carduus marianus, taraxacum officinale, chelidonium majus, leptandra virginica, myrica cerifera, berberis vulgaris, natrum sulphuricum, magnesia phosphorica, cuprum metallicum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60986-1008
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FRANGULA PURSHIANA BARK (UNII: 4VBP01X99F) (FRANGULA PURSHIANA BARK - UNII:4VBP01X99F)	FRANGULA PURSHIANA BARK	1 [hp_X] in 100 mL
SILYBUM MARIANUM SEED (UNII: U946SH95EE) (SILYBUM MARIANUM SEED - UNII:U946SH95EE)	SILYBUM MARIANUM SEED	1 [hp_X] in 100 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	1 [hp_X] in 100 mL
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	1 [hp_X] in 100 mL
VERONICASTRUM VIRGINICUM ROOT (UNII: M2O62YTN42) (VERONICASTRUM VIRGINICUM ROOT - UNII:M2O62YTN42)	VERONICASTRUM VIRGINICUM ROOT	2 [hp_X] in 100 mL
MORELLA CERIFERA ROOT BARK (UNII: S46HJ3710D) (MORELLA CERIFERA ROOT BARK - UNII:S46HJ3710D)	MORELLA CERIFERA ROOT BARK	2 [hp_X] in 100 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	2 [hp_X] in 100 mL
SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM SULFATE	6 [hp_X] in 100 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	8 [hp_X] in 100 mL
COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5)	COPPER	8 [hp_X] in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60986-1008-3	50 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	02/27/2018
2	NDC:60986-1008-4	100 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	02/27/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/01/1992

Labeler - Marco Pharma International LLC. (161994277)

Registrant - Marco Pharma International LLC. (161994277)

Name	Address	ID/FEI	Business Operations
Establishment
Nestmann Pharma GmbH		323426262	manufacture(60986-1008)

Revised: 12/2021

Document Id: d2bfd2b8-d3b7-e3bf-e053-2995a90a2901

Set id: 4b89ffcb-318b-416d-b13c-19fb94c2af70

Version: 5

Effective Time: 20211209