365 Whole Foods Market Guaifenesin Tablet, Extended Release
FDA Label NDC 42681-0057

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Whole Foods Market, Inc. for the product 365 Whole Foods Market Guaifenesin (NDC 42681-0057). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each extended-release tablet)
 Guaifenesin USP 600 mg

Purpose

Expectorant

Uses


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

Warnings

Do not use


  • for children under 12 years of age

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)

Stop Use And Ask A Doctor If


  • 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,

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 right away (1-800-222-1222).

Directions

  • do not crush, chew, or break extended-release 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 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours
  • children under 12 years of age: do not use

Other Information

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

Inactive Ingredients


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

Questions?

1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)


DISTRIBUTED BY:
WHOLE FOODS MARKET
550 BOWIE STREET, AUSTIN, TX 78703
©2025 WHOLE FOODS MARKET IP, INC.
www.wholefoodsmarket.com

PRODUCT OF INDIA

Package Label-Principal Display Panel - 600 Mg (20 Tablets Container Label)

365
WHOLE FOODS
MARKET

NDC 42681-0057-1

Expectorant

Mucus Relief

Guaifenesin
Extended-Release Tablets 600mg
Guaifenesin 600mg- Expectorant
Relieves Chest Congestion
Thins & Loosens Mucus

12                        20
Hour               Extended-Release 
                        TABLETS

Fig (Guaifenesin Fig1)

Fig (Guaifenesin Fig1)


Package Label-Principal Display Panel - 600 Mg (20 Tablets Container Carton)

365
WHOLE FOODS
MARKET

NDC 42681-0057-1

Expectorant

Mucus Relief

Guaifenesin
Extended-Release Tablets 600mg
Guaifenesin 600mg - Expectorant

Compare to the Active Ingredient in Mucinex®**

 

Relieves Chest Congestion
Thins & Loosens Mucus

12 Hour

for Day or Night

 

ACTUAL SIZE               20

                          Extended-Release 
                                  TABLETS

Fig (Guaifenesin Fig2)

Fig (Guaifenesin Fig2)


* Please review the disclaimer below.