Guaifenesin

Manufacturer
Innovida Pharmaeutique Corporation
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:46:50

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure8 sections

Indications and uses

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

Dosage and administration

• Adults and children 12 years of age and over : take 1 tablet every 4 hours as needed • Children 6 to 10 under 12 years of age : take 1/2 tablet every 4 hours as needed • Children under 6 years of age : consult a doctor Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Label contents#

Full prescribing information#

Active Ingredient ( in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Ask doctor before use ifyou have
• persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysema
• cough is accompanied by excessive phlegm (mucus)
Stop use and ask doctor if
• Symptoms are accompanied by fever, rash or persistent headache
• cough persists for more than 1 week or tends to recur
A persistent cough may be a sign of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
• Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed
• Children under 6 years of age: consult a doctor

Do not exceed 6 doses in a 24 hour period or as directed by a doctor

Other information

SPL UNCLASSIFIED SECTION

store at 15°-30°C (59°-86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71800-049-06EA - Each71800-0492ca84755-9abf-4ada-a7d2-047d2a53267312025-05-14

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71800-04971800-049-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
46e119c4-d3aa-eefc-e063-6294a90a94f1e2889673-a8aa-4cb1-ba52-fb94b7b057ab2025-12-26WarningsExact identifier
spl id: 46e119c4-d3aa-eefc-e063-6294a90a94f1
spl set id: e2889673-a8aa-4cb1-ba52-fb94b7b057ab

Reported adverse events (FAERS/openFDA)#

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