FDA Label for Gnp Mucus Relief PE

View Indications, Usage & Precautions

Gnp Mucus Relief PE Product Label

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

Otc - Active Ingredient



Active ingredient - (per tablet)

Guaifenesin   400 mg

Phenylephrine HCl  10 mg


Purpose



Guaifenesin.......................Expectorant

Phenylephrine HCl..............Nasal decongestant


Uses



Temporarily relieves symptoms associated with a cough ,the common cold,hay fever or other upper respiratory allergies.

  • helps loosen phlegm (mucus)
  • clear nasal passageways
  • loosens nasal congestion
  • drain bronchial tubes
  • shrinks swollen membranes
  • clears stuffy nose
  • makes coughs more productive
  • thin bronchial secretions

Warnings



Do not exceed recommended dosage


Do Not Use



This product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression,
psychiatric or emotional conditions, or Parkinson’s Disease), or for 2 weeks after stopping the
MAOI drug. If you are uncertain whether your prescription drug contains an MAOI, ask a health
professional.


Ask A Doctor Before Use If You Have



  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • excessive phlegm;mucus
  • difficulty in urination due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking,asthma,chronic bronchitis or emphysema

Stop Use And Ask A Doctor If



  • nervousness, dizziness or sleeplessness occurs
  • symptoms are accompanied by fever, rash, persistent headache or excessive phlegm (mucus)
  • cough and congestion do not improve within 7 days or tend to recur.
  • These could be signs of a serious condition.


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 the reach of children. In case of overdose, get medical help or contact a Poison
Control Center immediately.


Directions



  • adults and children 12 years and over: take 1 caplet every 4 hours as needed
  • children 6 to under 12 years: take 1/2 caplet every 4 hours as needed
  • children under 6 years: consult a doctor
  • Do not exceed 6 doses in a 24 hour period or as directed by a doctor.


Inactive Ingredients



croscarmellose sodium, Hypromellose, lactose, magnesium silicate, magnesium stearate maltodextrin, microcrystalline cellulose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide, triacetin


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