FDA Label for Foster And Thrive Chest Congestion Relief Pe PE

View Indications, Usage & Precautions

Foster And Thrive Chest Congestion Relief Pe PE Product Label

The following document was submitted to the FDA by the labeler of this product active Ingredient - (per Tablet)

dextromethorphan Hydrobromide�� 20mg

guaifenesin� 400mg

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


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



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


Package Label.Principal Display Panel




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