Mucus Relief

Mucus Relief
SPL v2
SPL
SPL Set ID 01af03f1-5d1b-4893-b7db-7092ba66e842
Route
ORAL
Published
Effective Date 2020-11-20
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg)
Inactive Ingredients
Carbomer Homopolymer, Unspecified Type Hypromellose, Unspecified Cellulose, Microcrystalline Povidone, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: G233 Shape: capsule Color: white Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2019-09-23
Description

Guaifenesin 600 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 600 mg

Use(s)

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

Warning

.

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 Use

for children under 12 years of age

Questions?

1-800-616-2471

You may also report side effects to this phone number. 

Other Information
  • tamper evident: do not use if seal on the bottle printed "SEALED for YOU PROTECTION" is broken or missing. 
  • store between 20 to 25°C (68 to 77°F)
Inactive Ingredients

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 600 mg
12 71610-499-12
60 71610-499-53

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20201217JH

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.
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).

If Pregnant Or Breast Feeding,

ask a health professional before use.

Principal Display Panel 600 Mg

NDC 71610-499 - Guaifenesin ER 600 mg Tablets

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)
Active Ingredient(in Each Extended Release Tablet)

Guaifenesin 600 mg

Structured Label Content

Use(s) (USE(S))

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

Purpose (PURPOSE)

Expectorant

Warning (WARNING)

.

Directions (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 Use (DO NOT USE)

for children under 12 years of age

Questions? (QUESTIONS?)

1-800-616-2471

You may also report side effects to this phone number. 

Other Information (OTHER INFORMATION)
  • tamper evident: do not use if seal on the bottle printed "SEALED for YOU PROTECTION" is broken or missing. 
  • store between 20 to 25°C (68 to 77°F)
Inactive Ingredients (INACTIVE INGREDIENTS)

carbomer homopolymer, hypromellose, microcrystalline cellulose, povidone

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count 600 mg
12 71610-499-12
60 71610-499-53

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:



Cookeville, TN 38506



20201217JH

Stop Use and Ask A Doctor If (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.
Keep Out of Reach of Children (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).

If Pregnant Or Breast Feeding, (IF PREGNANT OR BREAST-FEEDING,)

ask a health professional before use.

Principal Display Panel 600 Mg (PRINCIPAL DISPLAY PANEL - 600 mg)

NDC 71610-499 - Guaifenesin ER 600 mg Tablets

Ask A Doctor Before Use If You Have (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)
Active Ingredient(in Each Extended Release Tablet) (ACTIVE INGREDIENT(in each extended-release tablet))

Guaifenesin 600 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:32.885800 · Updated: 2026-03-14T22:59:33.610229