Guaifenesin And Pseudoephedrine Hcl Tablet, Extended Release
FDA Label NDC 62207-828

(in each extended-release tablet)

Guaifenesin USP, 600 mg

Pseudoephedrine HCL USP, 60 mg



Guaifenesin USP, 1200 mg

Pseudoephedrine HCL USP, 120 mg

Expectorant

Nasal Decongestant

• 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

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.

• 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)

• do not use more than directed

• 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.

ask a health professional before use.

 In case of overdose, get medical help or contact a Poison Control Centre right away (1-800 222-1222).

• 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

• 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)

carbomer homopolymer Type B, cellulose microcrystalline, hypromellose, lake of FD&C yellow 6, magnesium stearate, sodium starch glycolate Type A

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

You may also report side effects to this phone number.

Keep the carton.
It contains important information. See end panel for
expiration date.

Manufactured By:

Granules India Limited

Hyderabad – 500 081, INDIA

MADE IN INDIA

Distributed By:

Granules USA, Inc.

Parsippany, NJ 07054