FDA Label for Mucinex

View Indications, Usage & Precautions

Mucinex Product Label

The following document was submitted to the FDA by the labeler of this product Bryant Ranch Prepack. 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.

Other



Drug Facts


Active Ingredient (In Each Extended-Release Bi-Layer Tablet)



Guaifenesin 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

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.

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - 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.


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



  • store at 20-25°C (68-77°F)

Inactive Ingredients



carbomer homopolymer type B; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF


Questions?



1-866-MUCINEX (1-866-682-4639)

You may also report side effects to this phone number.


How Supplied



Product: 63629-7886

NDC: 63629-7886-1 20 TABLET, EXTENDED RELEASE in a BOTTLE

NDC: 63629-7886-2 40 TABLET, EXTENDED RELEASE in a BOTTLE


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