FDA.reportPublic FDA data

Guaifenesin 200mg

Manufacturer
HEALTHLIFE OF USA LLC | HHH PHARMA USA, LLC dba/HHH Pharmaceuticals | Elysium Pharmaceuticals Ltd
Effective date
2026-10-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-10-07 01:03:12

Label at a glance#

ProductGuaifenesin 200mg
Active ingredientGUAIFENESIN
Label structure9 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 tablet 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 tablet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 200 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 too much phlegm (mucus)

When using this product

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

Stop use and ask a doctor ifcough lasts for more than 7 days please consult your physicain or healthcare provider.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 tablet a day.
  • Children under 12 years:Do not use.
  • Do not exceed 4 doses in 24 hours.

Other Information

SAFE HANDLING WARNING SECTION

  • 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 Ingredients

INACTIVE INGREDIENT SECTION

Croscarmellose Sodium, Maltodextrin, Polyvinyl Pyrrolidone (PVPK30), Colloidal Silicon Dioxide, Microcrystalline Cellulose (PH-102), Stearic Acid Powder

Questions or comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

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 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69517-14869517-148-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GUAIFENESIN495W7451VQACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MALTODEXTRIN7CVR7L4A2DIACT
POVIDONE K30U725QWY32XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STEARIC ACID4ELV7Z65APIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-08-22full-release2026-06-01 01:11:33

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
3cf7d8e6-a2ef-d0be-e063-6294a90a84efd6aa1493-bc22-a318-e053-2995a90a63812025-08-22WarningsExact identifier
spl set id: d6aa1493-bc22-a318-e053-2995a90a6381

Reported adverse events (FAERS/openFDA)#

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