FDA.reportPublic FDA data

Cough Tonic

Manufacturer
Professional Complementary Health Formulas | Natural Pharmaceutical Manufacturing LLC
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:50:03

Label at a glance#

ProductCough Tonic 2995
Active ingredientSPONGIA OFFICINALIS SKELETON, ROASTED, ACONITUM NAPELLUS WHOLE, AMARYLLIS BELLADONNA WHOLE, BRYONIA ALBA ROOT, PULSATILLA MONTANA WHOLE, IPECAC, ARSENIC TRIOXIDE, DROSERA ROTUNDIFOLIA WHOLE
Label structure9 sections

Dosage and administration

Place liquid under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take one teaspoon up to 2 times per day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Spongia tosta 2X
Aconitum napellus 3X
Belladonna 3X
Bryonia 3X
Pulsatilla 4X
Ipecacuanha 5X
Arsenicum album 6X
Drosera rotundifolia 6X

QUESTIONS

OTC - QUESTIONS SECTION

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

INDICATIONS & USAGE SECTION

Temporarily reduces the intensity of coughing and congestion.*

OTC - PURPOSE SECTION

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS

WARNINGS SECTION

A persistent cough may be a sign of a serious condition. If cough persists, tends to recur, or is accompanied by a fever, rash, or other symptoms, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a healthcare professional before use.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Place liquid under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take one teaspoon up to 2 times per day. Consult a physician for use in children under 12 years of age.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Glycyrrhiza glabra root extract (1:1), polygala tenuifolia root extract (1:1), grindelia camporum aerial parts extract (1:1), inula helenium root extract (1:1), thymus vulgaris leaves extract (1:1), verbascum thapsus leaves extract (1:2), asclepias tuberosa root extract (1:1), zingiber officinale root extract (1:1), pimpinella anisum seed extract (1:1), 15% vegetable glycerin (from soy), 10% ethanol, 5% cherry extract, purified water.

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Est 1985

Professional Formulas

Complementary Health

Cough Tonic

Homeopathic Remedy

4 FL. OZ. (118 mL)

Label imageLabel image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63083-2995-42026-01-08C16284748780-11030e365-0956-111a-e063-dadaa90a10e2CCT
63083-2995-42026-01-08C16284748780-11030e365-0956-111a-e063-dadaa90a10e2CCT
63083-2995-42024-01-30C16284748780-11030e365-0956-111a-e063-dadaa90a10e2CCT
63083-2995-42024-01-30C16284748780-11030e365-0956-111a-e063-dadaa90a10e2CCT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63083-2995-4Cough Tonic2995118 mL in 1 BOTTLE, DROPPERLIQUID1182

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
63083-299563083-2995-4

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
ACONITUM NAPELLUS WHOLEU0NQ8555JDACTIB
AMARYLLIS BELLADONNA WHOLE11B89M58UNACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
PULSATILLA MONTANA WHOLE24K790T39BACTIB
IPECAC62I3C8233LACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
DROSERA ROTUNDIFOLIA WHOLEQR44N9XPJQACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12019-08-15full-release2026-06-01 02:16:20

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
Cough Tonic 2995COUGH TONICProfessional Complementary Health Formulas71d46da9-9e1d-43da-8664-b5579e9fd4e32026-01-08WarningsExact identifier
ndc (package): 63083-2995-4
ndc (product): 63083-2995
ndc11 (package): 63083299504
spl id: 0e1d6fa8-32a5-4ade-b9e2-5d67ac9eac56
spl set id: 71d46da9-9e1d-43da-8664-b5579e9fd4e3

Reported adverse events (FAERS/openFDA)#

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