FDA.reportPublic FDA data

Guaifenesin 400 mg Caplets

Manufacturer
Health Pharma USA LLC
Effective date
2026-07-07
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
weekly-update
Hydrated at
2026-07-17 21:43:41

Label at a glance#

ProductMucus Relief
Active ingredientGUAIFENESIN
Label structure10 sections

Indications and uses

Temporary symptomatic relief from congested chests and cough.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400 mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Uses

INDICATIONS & USAGE SECTION

  • Temporary symptomatic relief from congested chests and cough.

Warnings

WARNINGS SECTION

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.

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).

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 information

OTHER SAFETY 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 using.
  • TEMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose sodium, Maltodextrin, PVP K30, Silicon dioxide, Microcrystalline cellulose, Stearic acid, Purified water.

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel-60 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Principal Display Panel-200 count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

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
71679-11971679-119-60, 71679-119-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MALTODEXTRIN7CVR7L4A2DIACT
POVIDONE K30U725QWY32XIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARIC ACID4ELV7Z65APIACT
GUAIFENESIN495W7451VQACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112025-06-18full-release2026-06-01 01:03:27

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
Mucus ReliefGUAIFENESIN 400 MGHealth Pharma USA LLCd60a3e9d-e88e-3b19-e053-2995a90a3e8d2026-07-07WarningsExact identifier
ndc (package): 71679-119-60
ndc (package): 71679-119-02
ndc (product): 71679-119
ndc11 (package): 71679011960
ndc11 (package): 71679011902
spl id: 55feab68-a22d-b260-e063-6294a90ad86a
spl set id: d60a3e9d-e88e-3b19-e053-2995a90a3e8d

Reported adverse events (FAERS/openFDA)#

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