Guaifenesin Extended-release 600 Mg Tablet, Extended Release
FDA Label NDC 53041-233

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Guardian Drug Company for the product Guaifenesin Extended-release 600 Mg (NDC 53041-233). 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(in each extended-release tablet), purpose, use(s), warning, do not use, ask a doctor before use if you have, stop use and a ask doctor if, if pregnant or breast-feeding,, 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 600 mg

Purpose

Expectorant

Expectorant

Use(S)

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

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

Warning

.

Do Not Use

for children under 12 years of age


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)

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

Stop Use And A Ask 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. 

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).

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 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 tablets every 12 hours.  
  • Do not exceed 4 tablets in 24 hours.
  • children under 12 years of age: do not use

    • 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

  • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
  • store between 20 to 25°C (68 to 77°F)
    • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
    • store between 20 to 25°C (68 to 77°F)

Inactive Ingredients

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

Questions?

1-609-860-2600 
Hours: 8am - 4pm, EST 
You may also report side effects to this phone number.

1-609-860-2600

Hours: 8am - 4pm, EST

You may also report side effects to this phone number. 

Active Ingredient (In Each Extended-Release Tablet)

Guaifenesin 1200 mg  

Warnings

.

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.

Principal Display Panel 600 Mg

NDC 53041-233-32

GUARDIAN

12 HOUR

Guaifenesin

Extended-Release

Tablets 600 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucus

20 EXTENDED-RELEASE TABLETS

600 (600mg)

600 (600mg)

Principal Display Panel 1200 Mg

NDC 53041-234-58

GUARDIAN

12 HOUR

MAXIMUM STRENGTH

Guaifenesin

Extended-Release

Tablets 1200 mg

Expectorant

Relieves Chest Congestion

Thins and Loosens Mucuc

14 EXTENDED-RELEASE TABLETS

1200 (1200mg)

1200 (1200mg)

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