GUAIFENESIN

Manufacturer
Sam's West Inc | Aurohealth LLC | APL HEALTHCARE LIMITED
Effective date
2023-08-02
Label type
Human OTC Drug Label
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:27:48

Label at a glance#

ProductGUAIFENESIN
Active ingredientGUAIFENESIN
Label structure13 sections

Indications and uses

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

Dosage and administration

do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for the timing of meals adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. children under 12 years of age: do not use

Storage and handling

store between 20 - 25°C (68 - 77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each extended-release tablet)

Guaifenesin, USP 1200 mg

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 and make coughs more productive

Warnings

WARNINGS SECTION


Do not use

  • for children under 12 years of age

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION


  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)

Stop use and ask a doctor if

OTC - STOP USE SECTION


  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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 right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not crush, chew, or break tablet
  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.
  • children under 12 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

  • store between 20 - 25°C (68 - 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION


colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinised starch (maize)

Questions?

OTC - QUESTIONS SECTION

call toll-free Monday to Friday 8:30 am to 5:00 pm EST at 1-800-406-7984.

DISTRIBUTED BY:
SAM’S WEST, INC.
BENTONVILLE, AR 72716

PRODUCT OF INDIA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg (56 Extended-Release Tablets Blister Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Maximum Strength Mucinex®
active ingredient*

NDC 68196-941-56

Member's Mark™

Maximum Strength
Mucus Relief
Guaifenesin Extended-Release
Tablets, 1200 mg
Expectorant

  • Relieves chest congestion
  • Thins and loosens mucus

12
HOUR

69
actual size

56
Extended-
Release
Tablets


PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg (20 Tablet Label)PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg (20 Tablet Label) 


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
68196-94168196-941-56

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
06451fe8-6692-4ed4-985f-528acc3e0933fd97e38b-c3f9-2aac-e053-6294a90a2c262023-09-08WarningsExact identifier
spl set id: fd97e38b-c3f9-2aac-e053-6294a90a2c26

Reported adverse events (FAERS/openFDA)#

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