Guaifenesin Tablets, USP 400 mg

Manufacturer
Health Pharma USA LLC | Elysium Pharmaceuticals Ltd. | HHH Pharmaceuticals
Effective date
2025-12-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:20:14

Label at a glance#

ProductGuaifenesin
Active ingredientGUAIFENESIN
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Guaifenesin 400 mg

OTC - PURPOSE SECTION

Purpose

Expectorant

INDICATIONS & USAGE SECTION

Uses

  • Temporary symptomatic relief from congested chests and cough.

WARNINGS SECTION

​Warnings

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache, consult a doctor.

OTC - ASK DOCTOR SECTION

ask a doctor before use if you have

  • Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.
  • Cough accompanied by excessive phlegm (mucus).

OTC - WHEN USING SECTION

When using this product

  • Do not exceed recommended dosage.
  • Do not consume alcohol, benzodiazepines or opioids.

OTC - STOP USE SECTION

Stop use and ask a doctor if

cough lasts for more than 7 days please consult your physician or healthcare provider.

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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 12 years of age and over:take 1 caplet a day.
  • Children under 12 years:Do not use.
  • Do not exceed 4 doses in 24 hours.

OTHER SAFETY INFORMATION

Other information
■ Store at 25°C (77°F) excursions between 15°-30°C (59°-86°F).
■ Keep in a dry place and do not expose to heat.
■ Read all product information before use.
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

INACTIVE INGREDIENT SECTION

Inactive ingredients
Croscarmellose sodium, Maltodextrin, PVP K30, Silicon dioxide, Microcrystalline cellulose, stearic acid, Purified water.

OTC - QUESTIONS SECTION

Questions or comments?

Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

71679-309-02-MucusRelief-Guai 400mg-200s-FINAL71679-309-02-MucusRelief-Guai 400mg-200s-FINALLabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359601guaiFENesin 400 MG Oral TabletPSN5
359601guaifenesin 400 MG Oral TabletSCD5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GUAIFENESIN Pharmacologic Class Indexing1Indexing - Pharmacologic Class20211129

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130371679309023GTIN-13: 0371679309023
EAN-13: 0371679309023
GTIN-12: 371679309023
UPC-A: 371679309023
GTIN storage (14 digits): 00371679309023
71679-309-02-MucusRelief-Guai 400mg-200s-FINAL.jpg

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71679-309-002025-12-05C16284748780-13b156c62-32c5-fb37-e063-e6dba90a4e07Guaifenesin Tablets, USP 400 mg
71679-309-022025-12-05C16284748780-13b156c62-32c5-fb37-e063-e6dba90a4e07Guaifenesin Tablets, USP 400 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71679-309-00Guaifenesin38500 in 1 BOTTLETABLET385005
71679-309-02Guaifenesin200 in 1 BOTTLETABLET2005

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71679-30971679-309-00, 71679-309-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
GuaifenesinGUAIFENESINHealth Pharma USA LLC31755594-3e1c-b290-e063-6394a90aba612025-12-05WarningsExact identifier
ndc (package): 71679-309-00
ndc (package): 71679-309-02
ndc (product): 71679-309
ndc11 (package): 71679030900
ndc11 (package): 71679030902
spl id: 45395c54-4eb3-fd26-e063-6294a90a9f93
spl set id: 31755594-3e1c-b290-e063-6394a90aba61

Reported adverse events (FAERS/openFDA)#

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