FDA.reportPublic FDA data

FERRUM PHOSPHORICUM

Manufacturer
SEVENE USA
Effective date
2025-02-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:32:06

Label at a glance#

ProductFERRUM PHOSPHORICUM 6X
Active ingredientFERROSOFERRIC PHOSPHATE
Label structure11 sections

Indications and uses

Low grade fever, head cold, sore throat**.

Dosage and administration

(adults/children) Dissolve 5 pellets under the tongue three times a day until symptoms are relieved or as directed by a doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

FERRUM PHOSPHORICUM 6X**

**C, K, CK & X are homeopathic dilutions.

Traditionally used for temporary relief from:

OTC - PURPOSE SECTION

Low grade fever, head cold, sore throat*

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

  • (adults/children) Dissolve 5 pellets under the tongue three times a day until symptoms are relieved or as directed by a doctor.

USES:

INDICATIONS & USAGE SECTION

Low grade fever, head cold, sore throat**.

WARNINGS:

WARNINGS SECTION

  • Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.
  • In case of overdose, get medical help.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

  • Store at room temperature.
  • Do not use if tamper-evidence seal is broken.
  • Organic verified by Alpes Control 2021/A03M216K/1.

INACTIVE INGREDIENT:

INACTIVE INGREDIENT SECTION

ORGANIC SUCROSE

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Email us at: info@ollois.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Ferrum Phosphoricum_6X_80ct01b LBL_Ferrum Phosphoricum_6X_80ct

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76472-4091-12025-02-11C16284748780-12cef2736-8239-d83d-e063-dadaa90ab31fSEVENE USA (as PLD) - FERRUM PHOSPHORICUM 6X (76472-4091)
76472-4091-12025-01-30C16284748780-12cef2736-8239-d83d-e063-dadaa90ab31fSEVENE USA (as PLD) - FERRUM PHOSPHORICUM 6X (76472-4091)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76472-4091-1FERRUM PHOSPHORICUM6X80 in 1 CYLINDERPELLET804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76472-4091FERRUM PHOSPHORICUM 6X (FERRUM PHOSPHORICUM) PELLET [SEVENE USA]4Current NDC, 1 package rows20250213_ff0d3c90-5ed7-bcfc-e053-6294a90aee8d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-409176472-4091-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FERRUM PHOSPHORICUM 6XFERRUM PHOSPHORICUMSEVENE USAff0d3c90-5ed7-bcfc-e053-6294a90aee8d2025-02-11WarningsExact identifier
ndc (package): 76472-4091-1
ndc (product): 76472-4091
ndc11 (package): 76472409101
spl id: 2ddc4524-8118-e7c3-e063-6394a90ac147
spl set id: ff0d3c90-5ed7-bcfc-e053-6294a90aee8d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.