FDA.reportPublic FDA data

Cough

Manufacturer
Deseret Biologicals, Inc. | Apotheca Company
Effective date
2024-02-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:26:06

Label at a glance#

ProductCough
Active ingredientIPECAC, LOBARIA PULMONARIA, PHOSPHORUS, ANTIMONY POTASSIUM TARTRATE, WOOD CREOSOTE, ACONITUM NAPELLUS WHOLE, BRYONIA ALBA ROOT, HYOSCYAMUS NIGER, SILICON DIOXIDE, TOBACCO LEAF, HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED, TETANUS TOXIN
Label structure9 sections

Indications and uses

• For the temporary relief of symptoms including: • cough • fever • congestion These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Dosage and administration

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Aconitum Napellus 8X, Antimonium Tartaricum 6X, Bryonia (Alba) 8X, Hyoscyamus Niger 8X, Ipecacuanha 4X, Kreosotum 6X, Pertussinum 30X, Phosphorus 5X, Silicea 8X, Sticta Pulmonaria 4X, Tabacum 8X, Tetanus Toxin 30X.

PURPOSE:

OTC - PURPOSE SECTION

Aconitum Napellus - Cough, Antimonium Tartaricum - Congestion, Bryonia (Alba) - Fever, Hyoscyamus Niger - Cough, Ipecacuanha - Cough, Kreosotum - Congestion, Pertussinum - Fever, Phosphorus - Congestion, Silicea - Cough, Sticta Pulmonaria - Congestion, Tabacum - Fever, Tetanus Toxin - Fever

USES:

INDICATIONS & USAGE SECTION

• For the temporary relief of symptoms including:

• cough • fever • congestion

These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.

Tamper Evident: Sealed for your protection.

Do not use if seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, contact a physician or Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized water, 25% ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. By: Deseret Biologicals, Inc.
469 W. Parkland Drive
Sandy, UT 84070

www.desbio.com

800-827-8204

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DesBio

Cough

Homeopathic
NDC 43742-1968-1
1 FL OZ (30 ml)

CoughCough

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43742-1968-1Cough30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43742-1968COUGH (IPECACUANHA, STICTA PULMONARIA, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, ACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, SILICEA, TABACUM, PERTUSSINUM, TETANUS TOXIN) LIQUID [DESERET BIOLOGICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20240220_4a8deb4a-9f26-46a9-8d99-99df36407f22.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43742-196843742-1968-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
IPECAC62I3C8233LACTIB
LOBARIA PULMONARIAD1YM0P5Z2TACTIB
PHOSPHORUS27YLU75U4WACTIB
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
ACONITUM NAPELLUS WHOLEU0NQ8555JDACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
TOBACCO LEAF6YR2608RSUACTIB
HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTEDU364V64HUNACTIB
TETANUS TOXINRS7296A9LBACTIB
WATER059QF0KO0RIACT
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
CoughIPECACUANHA, STICTA PULMONARIA, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, ACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, SILICEA, TABACUM, PERTUSSINUM, TETANUS TOXINDeseret Biologicals, Inc.4a8deb4a-9f26-46a9-8d99-99df36407f222024-02-19WarningsExact identifier
ndc (package): 43742-1968-1
ndc (product): 43742-1968
ndc11 (package): 43742196801
spl id: dab7095e-395e-4075-bfcc-d9460c674c5f
spl set id: 4a8deb4a-9f26-46a9-8d99-99df36407f22

Reported adverse events (FAERS/openFDA)#

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