FOSTER AND THRIVE CHEST CONGESTION RELIEF PE PE- guaifenesin/phenylephrine tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)

Available from:

Strategic Sourcing Services LLC

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Guaifenesin.......................Expectorant Phenylephrine HCl..............Nasal decongestant 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 ■ 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. ■ 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 ■ nervousness, dizziness

Authorization status:

OTC monograph final

Summary of Product characteristics

FOSTER AND THRIVE CHEST CONGESTION RELIEF PE PE-
GUAIFENESIN/PHENYLEPHRINE TABLET
STRATEGIC SOURCING SERVICES LLC
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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DRUG FACTS
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.
IF PREGNANT OR BREAST-FEEDING, ask a health
professional before use.
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 y