MedPath

Influenzinum

INFLUENZINUM 30X

Approved
Approval ID

3dfd0bfa-9ca9-a5ea-e063-6394a90ad25f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 4, 2025

Manufacturers
FDA

Boiron

DUNS: 282560473

Products 1

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

INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0220-5105
Product Classification
G
Generic Name
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED), INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 4, 2025
FDA Product Classification

INGREDIENTS (5)

LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
INFLUENZA A VIRUS A/CROATIA/10136RV/2023 X-425A (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 30 [hp_X] in 1 1
Code: HQW9FZS4YK
Classification: ACTIB
INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 30 [hp_X] in 1 1
Code: TZK7Q3545Q
Classification: ACTIB
INFLUENZA A VIRUS A/VICTORIA/4897/2022 IVR-238 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED)Active
Quantity: 30 [hp_X] in 1 1
Code: AU5C98U4BB
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/4/2025

Uses: See symptoms on front panel.

Relieves after effects of flu or flu-like symptoms *

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/4/2025

Active ingredient**: See product name on front panel (contains 0.443 mg of the active ingredient per pellet).

INFLUENZINUM 30X HPUS

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/4/2025

Relieves after effects of flu or flu-like symptoms *

WARNINGS SECTION

LOINC: 34071-1Updated: 9/4/2025

Warnings

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/4/2025

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 9/4/2025

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/4/2025

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/4/2025

Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/4/2025

lactose, sucrose

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/4/2025

BoironUSA.com Info@boiron.com
** 1-800-BOIRON-1**(1-800-264-7661)
Distributed by Boiron, Inc.
Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/4/2025

Do not use if pellet dispenser seal is broken.
Contains approx.80 pellets.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

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