SEVENE USA - Cold Confort - Cold and Cough

Manufacturer
SEVENE USA
Effective date
2026-08-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-08-21 02:00:51

Label at a glance#

ProductCold Comfort Cold and Cough
Active ingredientSAMBUCUS NIGRA FLOWERING TOP, ALLIUM CEPA WHOLE, STRYCHNOS NUX-VOMICA SEED, SCHOENOCAULON OFFICINALE SEED, RUMEX CRISPUS ROOT, PULSATILLA VULGARIS WHOLE, EUPHRASIA OFFICINALIS LEAF, HYDRASTIS CANADENSIS WHOLE
Label structure11 sections

Dosage and administration

Adults/Children above 6 : spray 2 shots directly under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Storage and handling

Store at 59-77°F.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Allium Cepa 5C - Euphrasia Officinalis 5C - Hydrastis Canadensis 5C - Nux Vomica 5C - Pulsatilla 5C - Rumex Crispus 5C – Sabadilla 5C - Sambucus Nigra 5C.

TRADITIONALLY USED FOR

OTC - PURPOSE SECTION

This homeopathic medicine is made from a combination of ingredients traditionally used to relieve symptoms of:

- Mild Dry Teasing Cough

- Runny, Stuffy, Congested, Nose with Watery, Thick, or Yellow Discharges

- Loss Of Smell

- Sneezing

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults/Children above 6 : spray 2 shots directly under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

USE

INDICATIONS & USAGE SECTION

ALLIUM CEPA

Runny Nose with Clear Discharge - Sneezing - Watery Eyes .*

EUPHRASIA OFFICINALIS

Allergies with Abundant and Irritating Eye Discharge .*

HYDRASTIS CANADENSIS

Postnasal Drip - Stomach Ache with Constipation .*

NUX VOMICA

Indigestion, Heartburn, Drowsiness, Nausea from Overindulgence/Overeating .*

PULSATILLA

Ocular or Nasal Yellow Discharge Associated with Cold .*

RUMEX CRISPUS

Dry, Tickling, Persistent Cough Worsened by Cold Air .*

SABADILLA

Allergic Rhinitis (Hay Fever): Frequent Sneezing, Runny Nose, Nasal Itching, and Watery Eyes .*

SAMBUCUS NIGRA

Respiratory Disorders: Nasal congestion - Spasmodic/Suffocative Cough (nocturnal) - Croup - Asthma-like breathing difficulties .*

WARNINGS

WARNINGS SECTION

Consult a physician for use in children under 6 years of age.

Contact a doctor if symptoms persist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

STORAGE AND HANDLING SECTION

Store at 59-77°F.

OTC - DO NOT USE SECTION

Do not use if seal is broken or missing.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Organic Alcohol 20%

Purified Water

QUESTIONS?

OTC - QUESTIONS SECTION

Distributed by Sevene USA

East Troy, WI 53120 USA

1-855 - OLLOMED

QUESTIONS? info@ollois.com

www.ollois.com

MADE IN FRANCE.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. No guarantee to be effective. A homeopathic dilution may not to be susceptible to scientific measurement. The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-700376472-7003-1, 76472-7003-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
Cold Comfort Cold and CoughALLIUM CEPA 5C, EUPHRASIA OFFICINALIS 5C, HYDRASTIS CANADENSIS 5C, NUX VOMICA 5C, PULSATILLA 5C, RUMEX CRISPUS 5C,SABADILLA 5C, SAMBUCUS NIGRA 5CSEVENE USA54e9282a-604d-4acd-e063-6394a90a59ff2026-08-18WarningsExact identifier
ndc (package): 76472-7003-2
ndc (package): 76472-7003-1
ndc (product): 76472-7003
ndc11 (package): 76472700301
ndc11 (package): 76472700302
spl id: 594f5d57-799c-8ef0-e063-6294a90a1761
spl set id: 54e9282a-604d-4acd-e063-6394a90a59ff

Reported adverse events (FAERS/openFDA)#

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