GUAIFENESIN D- guaifenesin and pseudoephedrine hydrochloride tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ), Pseudoephedrine Hydrochloride (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)

Available from:

Walgreen Company

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive - temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies - common cold - hay fever - upper respiratory allergies - temporarily restores freer breathing through the nose - promotes nasal and/or sinus drainage - temporarily relieves sinus congestion and pressure

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GUAIFENESIN D- GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET,
EXTENDED RELEASE
WALGREEN COMPANY
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GUAIFENESIN D
_DRUG FACTS_
_ACTIVE INGREDIENTS (IN EACH_
_EXTENDED-RELEASE TABLET)_
_PURPOSES_
Guaifenesin 600 mg
Expectorant
Pseudoephedrine HCl 60 mg
Nasal Decongestant
USES
helps loosen phlegm (mucus) and thin bronchial secretions to rid the
bronchial
passageways of bothersome mucus and make coughs more productive
temporarily relieves nasal congestion due to:
common cold
hay fever
upper respiratory allergies
temporarily restores freer breathing through the nose
promotes nasal and/or sinus drainage
temporarily relieves sinus congestion and pressure
WARNINGS
DO NOT USE 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 do not
know if your
prescription drug contains an MAOI, ask a doctor or pharmacist before
taking this
product.
ASK A DOCTOR BEFORE USE IF YOU HAVE
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland
persistent or chronic cough such as occurs with smoking, asthma,
chronic
bronchitis, or emphysema
cough accompanied by too much phlegm (mucus)
WHEN USING THIS PRODUCT
do not use more than directed
STOP USE AND ASK A DOCTOR IF
you get nervous, dizzy, or sleepless
symptoms do not get better within 7 days, come back or occur with a
fever, rash, or
persistent headache. These could be signs of a serious illness.
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
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 extended-release tablet
take with a full glass of water
this product can be administered without regard for timing of meals
adults and children 12 years and older: 2 extended-release tablets
every 12 hours;
not more than 4 exte