FDA.reportPublic FDA data

Hedera Helix Flowering Twig, Thyme, Marrubium Vulgare, and Glycyrrhiza Glabra

Manufacturer
Phytodyne Inc.
Effective date
2023-12-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:16:32

Label at a glance#

ProductHedera comp.
Active ingredientHEDERA HELIX FLOWERING TWIG, THYME, MARRUBIUM VULGARE WHOLE, GLYCYRRHIZA GLABRA
Label structure7 sections

Dosage and administration

Adults and children above 12 years: 2-5 drops 1-3 times daily in pure water before meals. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

Use

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

For the temporary relief of cough and sinus congestion

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children above 12 years: 2-5 drops 1-3 times daily in pure water before meals. Consult a physician for use in children under 12 years of age.

Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hedera helix Ø (N) 40%, Thymus vulgaris Ø (N) 35%, Marrubium vulgare Ø (N) 15%, Glycyrrhiza glabra Ø (N) 10%

INACTIVE INGREDIENT SECTION

Alcohol: 65

TAMPER-EVIDENT

SPL UNCLASSIFIED SECTION

Do not use if tamper evident strip is broken from base of cap.

WARNING

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a doctor if you are pregnant or nursing.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep away from children. In case of overdose, call a medical professional.

PRINCIPAL DISPLAY PANEL - 20 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CERES®
Homeopathic Medicine

Hedera comp.

Use: For the temporary relief of cough and
sinus congestion

Directions : Adults and children above 12 years: 2-5
drops 1-3 times daily in pure water before meals. Consult
a physician for use in children under 12 years of age.

0.67 fl. oz. (20ml)
Lot#: 1234567A
EXP: 99.9999

Principal Display Panel - 20 ml Bottle Label
Principal Display Panel - 20 ml Bottle Label

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13838-143213838-1432-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEDERA HELIX FLOWERING TWIG3D10KUA6BMACTIB
THYMECW657OBU4NACTIB
MARRUBIUM VULGARE WHOLE7A72MUN24ZACTIB
GLYCYRRHIZA GLABRA2788Z9758HACTIB
ALCOHOL3K9958V90MIACT

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
ce9a90fa-f444-4a3d-8b22-4294f2e259630dc44983-bf1f-43dd-8eaa-41e7c0781c9f2023-12-27WarningsExact identifier
spl id: ce9a90fa-f444-4a3d-8b22-4294f2e25963
spl set id: 0dc44983-bf1f-43dd-8eaa-41e7c0781c9f

Reported adverse events (FAERS/openFDA)#

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