Father Johns Medicine Cough syrup Original

Manufacturer
Prime Labs LLC dba Quality CDMO
Effective date
2025-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-06-03 17:45:11

Label at a glance#

ProductFather Johns Medicine Cough syrup Original
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Shake well before using. Do not take more than six doses in 24 hours.

Adults and children 12 years of age and over | 2 teaspoons every 4 hours

Children 6 years to under 12 years of age | 1 teaspoon every 4 hours

Children under 6 years of age | ask a doctor

WARNINGS SECTION

Do not use:

If youa re now taking a prescription monoamine oxidase inhibitor (MAOI) (Certain drugs for depression, psychiatric or emotional conditions, or parkinsons disease), or for 2 weeks after stopping the maoi drug. if you are uncertain whether your prescription contains a MAOI, consult a health professional before taking this product.

INACTIVE INGREDIENT SECTION

Carmael Color

Citric Acid

Cod liver oil

Flavors

Glycerin

Gum Arabic

Licorice

Purified Water

Sodium Benzoate

Sodium Citrate

Sugar

OTC - ACTIVE INGREDIENT SECTION

Dextromethorphan HBr....... 10 mg per teaspoon

INDICATIONS & USAGE SECTION

Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants.

OTC - PURPOSE SECTION

Cough Suppresant

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

Father Johns Original 8oz 2022Father Johns Original 8oz 2022Father Johns Original 4oz 2022Father Johns Original 4oz 2022fatherfather

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80587-18080587-180-01, 80587-180-02, 80587-180-03, 80587-180-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
43f43a50-7d06-f9d0-e063-6394a90aa23a43f43a39-514a-ab14-e063-6294a90afa992025-11-19WarningsExact identifier
spl id: 43f43a50-7d06-f9d0-e063-6394a90aa23a
spl set id: 43f43a39-514a-ab14-e063-6294a90afa99

Reported adverse events (FAERS/openFDA)#

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