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Plantago Pyrite

Plantago Pyrite

Approved
Approval ID

ce4ca5f0-1760-400a-b9bb-6efa3420ba19

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 16, 2025

Manufacturers
FDA

Uriel Pharmacy Inc.

DUNS: 043471163

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Plantago Pyrite

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code48951-8036
Product Classification
G
Generic Name
Plantago Pyrite
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 16, 2025
FDA Product Classification

INGREDIENTS (14)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
ECHINACEA, UNSPECIFIEDActive
Quantity: 3 [hp_X] in 1 mL
Code: 4N9P6CC1DX
Classification: ACTIB
ABIES ALBA LEAFY TWIGActive
Quantity: 6 [hp_X] in 1 mL
Code: CE3G3J56LR
Classification: ACTIB
SAGEActive
Quantity: 6 [hp_X] in 1 mL
Code: 065C5D077J
Classification: ACTIB
FERROSOFERRIC PHOSPHATEActive
Quantity: 7 [hp_X] in 1 mL
Code: 91GQH8I5F7
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 8 [hp_X] in 1 mL
Code: T7J046YI2B
Classification: ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOPActive
Quantity: 8 [hp_X] in 1 mL
Code: 1W0775VX6E
Classification: ACTIB
BEEF LUNGActive
Quantity: 17 [hp_X] in 1 mL
Code: 2I1RTO1MBR
Classification: ACTIB
PLANTAGO MAJOR LEAFActive
Quantity: 6 [hp_X] in 1 mL
Code: 7DC28K241X
Classification: ACTIB
THYROID, BOVINEActive
Quantity: 17 [hp_X] in 1 mL
Code: MN18OTN73W
Classification: ACTIB
FERROUS DISULFIDEActive
Quantity: 17 [hp_X] in 1 mL
Code: 132N09W4PR
Classification: ACTIB
BOS TAURUS NASAL MUCOSAActive
Quantity: 17 [hp_X] in 1 mL
Code: 343455G79K
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/16/2025

Plantago Pyrite Ampules

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/20/2014

Directions: FOR ORAL USE.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/20/2014

Use: Temporary relief of cough.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/20/2014

KEEP OUT OF REACH OF CHILDREN.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/20/2014

Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/20/2014

Active Ingredients: Echinacea e pl. tota (Purple coneflower) 3X, Abies e summ. (White fir) 6X, Plantago e fol. (Ribwort plantain) 6X, Salvia e fol. (Sage) 6X, Vivianite (Nat. ferrous phosphate) 7X, Bryonia e rad. (White bryony) 8X, Eupatorium can. ex herba (Hemp agrimony) 8X, Bronchi (Bovine bronchi) 17X, Larynx (Bovine larynx) 17X, Pyrite (Nat. Iron disulfide) 17X, Tunica mucosa nasi (Bovine nasal mucosa) 17X

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/16/2025

Inactive Ingredients: Water, Salt, Lactose

Prepared using rhythmical processes.

WARNINGS SECTION

LOINC: 34071-1Updated: 8/20/2014

Warnings: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Contains traces of lactose. Consult a doctor before use for serious conditions or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/20/2014

Questions? Call 866.642.2858
Uriel, East Troy, WI 53120
shopuriel.com

Lot:

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Plantago Pyrite - FDA Drug Approval Details