apo-TUSS

Manufacturer
PEKANA Naturheilmittel GmbH
Effective date
2022-12-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:18:48

Label at a glance#

Productapo-TUSS
Active ingredientArum Maculatum Root, Bryonia Dioica Root, Protortonia Cacti, Cupric Acetate, Gelsemium sempervirens Root, Hedera helix Flowering Twig, LACTUCA VIROSA WHOLE, Horseradish
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ingredients:
Armoracia rusticana4X
Arum maculatum4X
Bryonia cretica4X
Dactylopius coccus (Coccus cacti)2X
Cuprum aceticum4X
Gelsemium sempervirens4X
Hedera helix6X
Lactuca virosa4X

Selected ingredients prepared by spagyric processes.

INACTIVE INGREDIENT SECTION

Contains 20% alcohol by volume.

Indications

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

For relief of minor coughs. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.

Dosage

DOSAGE & ADMINISTRATION SECTION

Unless otherwise prescribed, adults take 15-20 drops, 3 times per day. For pediatric dosages, consult your practitioner.

Warning

WARNINGS SECTION

If symptoms persist, contact a licensed practitioner. If you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. If you are pregnant or nursing a baby, seek the advice of a health care professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

STORAGE AND HANDLING SECTION

Protect from light and heat.

Tamper Evident

SPL UNCLASSIFIED SECTION

Do not use this product if tamper evident strip is broken or removed from base of cap.

OTC - QUESTIONS SECTION

To report adverse events, contact BioResource at 321B Blodgett Street, Cotati, CA 94931

SPL UNCLASSIFIED SECTION

Distributed by:
BioResource Inc.
Cotati, CA 94931

Manufactured by:
PEKANA® GmbH
D-88353 Kisslegg

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

apo-TUSS™
Oral Drops

Homeopathic Medicine

For relief of
minor coughs

1.7 FL OZ
(50 ml)

PEKANA®

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box
PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59469-104-10apo-TUSS50 mL in 1 BOTTLE, GLASSSOLUTION/ DROPS505
59469-104-10apo-TUSS1 in 1 BOXSOLUTION/ DROPS15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59469-104APO-TUSS (ARUM MACULATUM ROOT, BRYONIA DIOICA ROOT, PROTORTONIA CACTI, CUPRIC ACETATE, GELSEMIUM SEMPERVIRENS ROOT, HEDERA HELIX FLOWERING TWIG, LACTUCA VIROSA, AND HORSERADISH) SOLUTION/ DROPS [PEKANA NATURHEILMITTEL GMBH]5Current NDC, Legacy NDC, 2 package rows20221208_eebfdf25-1beb-4e31-b62d-967c8f1b9844.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59469-10459469-104-10

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
apo-TUSSARUM MACULATUM ROOT, BRYONIA DIOICA ROOT, PROTORTONIA CACTI, CUPRIC ACETATE, GELSEMIUM SEMPERVIRENS ROOT, HEDERA HELIX FLOWERING TWIG, LACTUCA VIROSA, AND HORSERADISHPEKANA Naturheilmittel GmbHeebfdf25-1beb-4e31-b62d-967c8f1b98442022-12-06WarningsExact identifier
ndc (package): 59469-104-10
ndc (product): 59469-104
ndc11 (package): 59469010410
spl id: d0974a83-5638-481c-8b47-77c313f15dd1
spl set id: eebfdf25-1beb-4e31-b62d-967c8f1b9844

Reported adverse events (FAERS/openFDA)#

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