FDA Label for Mucus

View Indications, Usage & Precautions

Mucus Product Label

The following document was submitted to the FDA by the labeler of this product Amerisourcebergen Drug Corporation. 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.

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Drug Facts

Distributed By:
AmerisourceBergen,
1300 Morris Drive
Chesterbrook, PA 19087


Active Ingredient (In Each Extended-Release 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 (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 carton is open or if printed seal on blister is broken or missing.
  • •store between 20-25°C (68-77°F)

Inactive Ingredients



carbomer homopolymer type B; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF


Questions?



(1-800-406-7984)

You may also report side effects to this phone number.


Principal Display Panel - 600 Mg Tablet Blister Pack Carton



NDC 46122-416-60

Compare to
active ingredient in
Mucinex® †

GOOD
NEIGHBOR
PHARMACY®

12 HOUR

Mucus • ER
Guaifenesin Extended-Release
Tablets, 600 mg

Expectorant

  • •Relieves Chest Congestion
  • •Thins and Loosens Mucus
  • •Immediate and Extended Release
  •  20 Extended-Release Tablets

* Please review the disclaimer below.