MedPath

Cold Flu Relief Elderberry

Cold + Flu Relief Elderberry Syrup

Approved
Approval ID

27ec0362-b762-442e-ad82-1f17fe15858e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

Schwabe North America

DUNS: 831153908

Products 1

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

Cold Flu Relief Elderberry

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code53499-2845
Product Classification
G
Generic Name
Cold Flu Relief Elderberry
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (18)

PELARGONIUM SIDOIDES ROOTActive
Quantity: 1 [hp_X] in 120 mL
Code: H6J53HEX8E
Classification: ACTIB
ACONITUM NAPELLUSActive
Quantity: 4 [hp_X] in 120 mL
Code: U0NQ8555JD
Classification: ACTIB
EUCALYPTUS GLOBULUS LEAFActive
Quantity: 2 [hp_X] in 120 mL
Code: S546YLW6E6
Classification: ACTIB
SAMBUCUS NIGRA FLOWERING TOPActive
Quantity: 3 [hp_X] in 120 mL
Code: CT03BSA18U
Classification: ACTIB
BRYONIA ALBA ROOTActive
Quantity: 4 [hp_X] in 120 mL
Code: T7J046YI2B
Classification: ACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOPActive
Quantity: 6 [hp_X] in 120 mL
Code: 1W0775VX6E
Classification: ACTIB
GELSEMIUM SEMPERVIRENS ROOTActive
Quantity: 4 [hp_X] in 120 mL
Code: 639KR60Q1Q
Classification: ACTIB
IPECACActive
Quantity: 3 [hp_X] in 120 mL
Code: 62I3C8233L
Classification: ACTIB
PHOSPHORUSActive
Quantity: 6 [hp_X] in 120 mL
Code: 27YLU75U4W
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
EUROPEAN ELDERBERRYInactive
Code: BQY1UBX046
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

LH15845_B04_Umcka_ColdFluRelief_Syrup_LBL_4oz_FNL.jpg

LHBN15845_B04_Umcka_ColdFluRelief_Syrup_CTN_4oz_FNL.jpg

INDICATIONS & USAGE SECTION

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

Indications & Usage

Temporarily relieves flu symptoms.

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chills/fever, chest congestion, cough, headache, hoarseness, body aches, sore throat, sneezing, stuffy/runny nose, nasal congestion.

OTC - ACTIVE INGREDIENT SECTION

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

Active Ingredients

Pelargonium sidoides 1x

Aconitum napellus 4x

Eucalyptus globulus 2x

Sambucus nigra 3x

Bryonia 4x

Eupatorium perfoliatum 6x

Gelsemium sempervirens 4x

Phosphorus 6x

Ipecacuanha 3x

INACTIVE INGREDIENT SECTION

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

Inactive Ingredients

Citric Acid

Elderberry Extract

Ethyl Alcohol

Glycerin

Lactose Monohydrate

Maltodextrin

Natural Flavor

Potassium Sorbate

Purified Water

Sorbitol

DOSAGE & ADMINISTRATION SECTION

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

Dosage & Administration

Directions:

For best results, use at the first sign of symptoms and continue to use for an additional 48 hours after symptoms cease.

Shake well before each use.

Use only with enclosed dosage cup.

Adults & children 13 years of age and older: take 1½ teaspoons (tsp) (7.5 mL) three times daily.

Children 6 to 12 years of age: take 1 teaspoon (tsp) (5mL) three times daily.

Children under 6 years of age: consult a doctor.

OTC - PURPOSE SECTION

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

Purpose

Temporarily relieves flu symptoms.

Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chills/fever, chest congestion, cough, headache, hoarseness, body aches, sore throat, sneezing, stuffy/runny nose, nasal congestion.

WARNINGS SECTION

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

Warnings

Sore throat warning: if sore throat is severe or persists more than 2 days, is accompanied or followed by a fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 9/9/2025

Ask Doctor

Ask a doctor before use if you have: a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, a cough that is accompanied by excessive phlegm (mucus), been taking any medications, an allergy to plants of the Geraniaceae family.

OTC - STOP USE SECTION

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

Stop Use

Stop use and ask a doctor if new symptoms occur, symptoms get worse or last more than 7 days, fever worsens or lasts more than 3 days, cough lasts more then 7 days or occurs with rash or persistent headache.

These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Pregnancy or Breastfeeding

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Keep out of reach of children

Keep out of reach of children.

OVERDOSAGE SECTION

LOINC: 34088-5Updated: 9/9/2025

Overdose

In case of overdose, seek medical help or contact a Poison Control Center right away.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Cold Flu Relief Elderberry - FDA Drug Approval Details