EXCAUGH - FORTUNE PHARMACAL COMPANY, LIMITED

Manufacturer
FORTUNE PHARMACAL COMPANY, LIMITED
Effective date
2026-09-17
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-09-22 03:02:27

Label at a glance#

ProductEXCAUGH
Active ingredientGUAIFENESIN
Label structure13 sections

Storage and handling

Other information 
Phenylketonurics: Contains Phenylalanine 3.929 mg Per Tablet keep tightly sealed 
store between 20 to 25º C (68 to 77º F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)
Guaifenesin 100 mg

OTC - PURPOSE SECTION

Purpose
Expectorant

INDICATIONS & USAGE SECTION

Uses
helps loosen phlegm (mucus) and thin bronchial secretions to:
   rid the bronchial passageways of bothersome mucus
   make coughs more productive

WARNINGS SECTION

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the user has
a persistent or chronic cough such as occurs with:
   smoking
   asthma
   chronic bronchitis
   emphysema
a cough that is accompanied by excessive phlegm (mucus)
a high fever

OTC - STOP USE SECTION

Stop use and ask a doctor if
any of the following occurs (these could be signs of a serious condition):
   cough persists for more than 1 week
   cough tends to recur
   cough is accompanied by a fever, rash, or persistent headache

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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.

DOSAGE & ADMINISTRATION SECTION

Directions
adults and children 12 years of age and over: take 2 to 4 tablets every 4 hours, not to exceed 24 tablets (2,400 mg) in 24 hours
children 6 to under 12 years of age: take 1 to 2 tablets every 4 hours, not to exceed 12 tablets (1,200 mg) in 24 hours
children under 6 years of age: consult a doctor

STORAGE AND HANDLING SECTION

Other information

Phenylketonurics: Contains Phenylalanine 3.929 mg Per Tablet
keep tightly sealed

store between 20 to 25º C (68 to 77º F)

INACTIVE INGREDIENT SECTION

Inactive ingredientsaspartame, colloidal silicon dioxide, corn starch, D&C yellow no.10 aluminum lake, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate.

OTC - QUESTIONS SECTION

Questions or comments?(888) 221-3496 M-F 9 am to 5 pm
you may also report serious side effects to this phone number

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXCAUGH
Guaifenesin - Expectorant
NDC 51467-009-02
36 Tablets
IMAGE OF CARTONIMAGE OF CARTON

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51467-00951467-009-01, 51467-009-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-11-13full-release2026-06-01 01:16:07

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
438103e3-da3d-16c8-e063-6394a90ad7f360803d28-ea6e-4ab9-9cc9-4909b4681ecd2025-11-13WarningsExact identifier
spl set id: 60803d28-ea6e-4ab9-9cc9-4909b4681ecd

Reported adverse events (FAERS/openFDA)#

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