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  5. Label Information: Mucus Relief

FDA Label for Mucus Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT(IN EACH EXTENDED-RELEASE TABLET)
    2. PURPOSE
    3. USE(S)
    4. WARNING
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. REPACKAGING INFORMATION
    15. PRINCIPAL DISPLAY PANEL - 600 MG

Mucus Relief Product Label

The following document was submitted to the FDA by the labeler of this product Aphena Pharma Solutions - Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient(In Each Extended-Release Tablet)



Guaifenesin 600 mg


Purpose



Expectorant


Use(S)



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


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 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

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


Questions?



1-800-616-2471

You may also report side effects to this phone number. 


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:

Count600 mg
6071610-499-53

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:

Aphena Pharma Solutions - TN - Aphena

Aphena Pharma Solutions - TN - Aphena


Cookeville, TN 38506

20201217JH


Principal Display Panel - 600 Mg



NDC 71610-499 - Guaifenesin ER 600 mg Tablets

Bottle Label 600 mg - 71610 0499 53

Bottle Label 600 mg - 71610 0499 53


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