FDA.reportPublic FDA data

Father Johns Cough Medicine Plus

Manufacturer
Humco Holding Group, Inc
Effective date
2020-06-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:16:57

Label at a glance#

ProductFather Johns Cough Medicine Plus
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Each 30 mL (2 tablespoonfuls) contain:

Dextromethorphan HBr, 10mg

Phenylephrine HCl, 10mg

Chlorpheniramine Maleate, 4mg

INACTIVE INGREDIENT SECTION

Citric acid

FD&C Red #40

FD&C Blue #1

Glycerin

Purified water

Sodium benzoate

Sodium chloride

Sodium citrate

Sodium saccharin

Sucrose

DOSAGE & ADMINISTRATION SECTION

DO NOT take more than 12 tablespoonfuls in 24 hours

Adults and Children 12 years and older: take 2 tablespoons every 4 hours

Children under 12 years old: ask a doctor

INDICATIONS & USAGE SECTION

For temporarily relief of couch and allergy symptoms, including coughing, nasal congestion, and runny nose.

WARNINGS SECTION

WARNINGS: Do not excees recommended dosage

OTC - PURPOSE SECTION

Cough Supressant

Nasal Decongestant

Anthihistamine

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

fatherplusfatherplus'

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2167740chlorpheniramine maleate 4 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 10 MG in 30 mL Oral SolutionPSN1
2167740chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 0.333 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCD1
2167740chlorpheniramine maleate 0.133 MG/ML / dextromethorphan HBr 0.333 MG/ML / phenylephrine HCl 0.333 MG/ML Oral SolutionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
DEXTROMETHORPHAN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0395-9127-942022-07-29C16284748780-1e4f33bdf-ac01-d8a0-e053-dadaa90a6e4ePrivate Label Father John's Medicine Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0395-9127-94Father Johns Cough Medicine Plus118 mL in 1 CONTAINERLIQUID1181
0395-9127-94Father Johns Cough Medicine Plus1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0395-9127FATHER JOHNS COUGH MEDICINE PLUS (NASAL DECONGESTANT) LIQUID [HUMCO HOLDING GROUP, INC]1Legacy NDC, 2 package rows20200610_a7b05fbb-200e-2433-e053-2995a90a5275.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0395-91270395-9127-94

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHARIN SODIUMSB8ZUX40TYIACT
DEXTROMETHORPHAN HYDROBROMIDE9D2RTI9KYHACTIB
SUCROSEC151H8M554IACT
GLYCERINPDC6A3C0OXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM CHLORIDE451W47IQ8XIACT
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM BENZOATEOJ245FE5EUIACT

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
a7b08ca6-638b-beb0-e053-2a95a90a9bd3a7b05fbb-200e-2433-e053-2995a90a52752020-06-09WarningsExact identifier
spl id: a7b08ca6-638b-beb0-e053-2a95a90a9bd3
spl set id: a7b05fbb-200e-2433-e053-2995a90a5275

Reported adverse events (FAERS/openFDA)#

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