FDA.reportPublic FDA data

COLD and FLU RELIEF

Manufacturer
Clineva Management Services, LLC | HomeoCare Laboratories Inc. | HomeoCare Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:36:48

Label at a glance#

ProductCOLD and FLU RELIEF
Active ingredientGELSEMIUM SEMPERVIRENS ROOT, ATROPA BELLADONNA, EUPATORIUM CANNABINUM WHOLE, ALLIUM CEPA WHOLE, ACONITUM NAPELLUS, ARNICA MONTANA, SOLANUM DULCAMARA WHOLE
Label structure10 sections

Indications and uses

*For the temporary relief of minor fever, chills, runny nose, congestion, body aches adn fatigue due to the common cold or the flu.

Dosage and administration

Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissilve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.

Label contents#

Full prescribing information#

Inactive Ingredients

INACTIVE INGREDIENT SECTION


Sucrose

Lactose

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Acon. nap 14X, Allium cepa 8X, Arnica m. 8X, Belladonna 8X, Dulcamara 8X, Eupatorium cann. 8X, Gelsemium 18X

Directions:

DOSAGE & ADMINISTRATION SECTION

Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissilve under your tongue 3 times a day or as needed. Take apart from food or drinks. To preserve purity avoid touching pellets with fingers.

Warnings:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Uses:

OTC - PURPOSE SECTION

*For the temporary relief of minor fever, chills, runny nose, congestion, body aches adn fatigue due to the common cold or the flu.

Warnings:

OTC - ASK DOCTOR SECTION

If symptoms persist or worsen, or if pregnant or nursing, consult a doctor. Do not use if cap seal is broken or missing.

Question, Comments?

OTC - QUESTIONS SECTION

Call 1-844-254-6382

INDICATIONS & USAGE SECTION

For the temporary relief of minor fever, chills, runny nose, congestion, body aches and fatigue due to the common cold or the flu

WARNINGS SECTION

If symptoms persist or worsen, or if pregnant or nursing, consult a doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COLD&FLU RELIEFCOLD&FLU RELIEF

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71409-303-80COLD and FLU RELIEF80 in 1 VIAL, DISPENSINGPELLET804

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71409-30371409-303-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSEJ2B2A4N98GIACT
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
EUPATORIUM CANNABINUM WHOLE1UEC056CS0ACTIB
ALLIUM CEPA WHOLE8P2VLG2456ACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
ARNICA MONTANAO80TY208ZWACTIB
SUCROSEC151H8M554IACT
SOLANUM DULCAMARA WHOLEG72JA9DHK5ACTIB

Source Document#

Source XML · Source PDF

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
COLD and FLU RELIEFCOLD AND FLU RELIEFClineva Management Services, LLC544c918d-86cc-1f8d-e054-00144ff8d46c2026-01-12WarningsExact identifier
ndc (package): 71409-303-80
ndc (product): 71409-303
ndc11 (package): 71409030380
spl id: 4836bcd2-72fb-eb06-e063-6294a90ac032
spl set id: 544c918d-86cc-1f8d-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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