Guaifenesin and Pseudoephedrine HCl Extended-Release Tablets 600 mg and 60 mg; 1200 mg and 120 mg Drug Facts

ACTIVE INGREDIENS

(in each extended-release tablet)

Guaifenesin USP, 600 mg Pseudoephedrine HCL USP, 60 mg Guaifenesin USP, 1200 mg Pseudoephedrine HCL USP, 120 mg

PURPOSES

Expectorant 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 Centre 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 timing of meals • adults and children 12 years and older: For 600mg and 60mg: 2 tablets every 12 hours; not more than 4 tablets in 24 hours For 1200mg and 120mg: 1 tablet every 12 hours; not more than 2 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, cellulose microcrystalline, hypromellose, lake of FD&C yellow 6, magnesium stearate, sodium starch glycolate Type A