FDA.reportPublic FDA data

Natures Way Cold Flu Relief Fastactives Berry Flavored

Manufacturer
Universal Synergetics, Inc | Schwabe North America, Inc.
Effective date
2025-08-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:34:53

Label at a glance#

ProductNatures Way Cold Flu Relief Fastactives Berry Flavored
Active ingredientPELARGONIUM SIDOIDES WHOLE, ACONITUM NAPELLUS WHOLE, EUCALYPTUS GLOBULUS LEAF, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, GELSEMIUM SEMPERVIRENS ROOT, PHOSPHORUS, IPECAC
Label structure8 sections

Indications and uses

shortens duration and reduces severity of symptoms associated with the common cold and throat/ nasal/bronchial irritations  temporarily relieves flu symptoms chills/fever chest congestion nasal congestion cough headache hoarseness body aches sneezing/runny nose sore throat

Dosage and administration

tear packet open, pour contents into mouth and swallow for best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease  age  Dose  adults & children 13 years of age and older  take contents of 1 packet three times daily  children 6 -12 years of age  take contents of 1 packet two times daily  children under 6 years of age  consult a doctor

Label contents#

Full prescribing information#

Active ingredients (in each packet)

OTC - ACTIVE INGREDIENT SECTION

Pelargonium sidoides 1X

Aconitum napellus 4X, Eucalyptus globulus 2X

Bryonia 4X, Eupatorium perfoliatum 6X

Gelsemium sempervirens 4X, Phosphorus 6X

Ipecacuanha 3X

Purpose

OTC - PURPOSE SECTION

Shortens duration/reduces severity of upper respiratory symptoms

Pain reliever/fever reducer

Cough suppressant

Sneezing/runny nose/sore throat

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • shortens duration and reduces severity of symptoms associated with the common cold and throat/ nasal/bronchial irritations 
  • temporarily relieves flu symptoms
  • chills/fever
  • chest congestion
  • nasal congestion
  • cough
  • headache
  • hoarseness
  • body aches
  • sneezing/runny nose
  • sore throat

Warnings

WARNINGS SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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 Geraniaceaefamily

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • new symptoms occur, symptoms get worse or last more than 7 days
  • fever worsens or lasts more than 3 days
  • cough lasts more than 7 days or occurs with rash or persistent headache. These could be signs of a serious condition.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • tear packet open, pour contents into mouth and swallow
  • for best results, use at first sign of symptoms and continue to use for an additional 48 hours after symptoms cease
 age Dose
 adults & children 13 years of age and older take contents of 1 packet three times daily
 children 6 -12 years of age take contents of 1 packet two times daily
 children under 6 years of age consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • TAMPER EVIDENT.Packaged in individually sealed packets. Do not use if open or torn
  • store at room temperature 20-25°C (68-77°F) in a dry place out of direct sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, lactose monohydrate, malic acid, maltodextrin, natural flavor, silica, xylitol

Questions?

OTC - QUESTIONS SECTION

1-800-962-8873/ naturesway.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80228-0349-0Natures Way Cold Flu Relief Fastactives Berry Flavored0.9 g in 1 PACKETPOWDER0.92
80228-0349-0Natures Way Cold Flu Relief Fastactives Berry Flavored10 in 1 CARTONPOWDER102

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80228-034980228-0349-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MALIC ACID817L1N4CKPIACT
MALTODEXTRIN7CVR7L4A2DIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
XYLITOLVCQ006KQ1EIACT
PELARGONIUM SIDOIDES WHOLE4FY2944729ACTIM
ACONITUM NAPELLUS WHOLEU0NQ8555JDACTIB
EUCALYPTUS GLOBULUS LEAFS546YLW6E6ACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
PHOSPHORUS27YLU75U4WACTIB
IPECAC62I3C8233LACTIB

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
Natures Way Cold Flu Relief Fastactives Berry FlavoredPELARGONIUM SIDOIDES WHOLE, ACONITUM NAPELLUS WHOLE, EUCALYPTUS GLOBULUS LEAF, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM TOP, SEMPERVIRENS ROOT, PHOSPHORUS, IPECACUniversal Synergetics, Inc444081b1-c78f-4474-a084-e7bd2cc2eb3f2025-08-14WarningsExact identifier
ndc (package): 80228-0349-0
ndc (product): 80228-0349
ndc11 (package): 80228034900
spl id: 3c57cd26-bdc9-a26f-e063-6294a90a2c45
spl set id: 444081b1-c78f-4474-a084-e7bd2cc2eb3f

Reported adverse events (FAERS/openFDA)#

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