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Generic: guaifenesin and pseudoephedrine hcl is used for the treatment of Bronchitis Common Cold Cough Laryngitis Pharyngitis Rhinitis, Allergic, Perennial Sinusitis Whooping Cough Asthma


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Active Ingredients (in Each Extended-release Tablet)


(For 600 mg/60 mg)

Guaifenesin USP, 600 mg

Pseudoephedrine HCL USP, 60 mg (For 1200 mg/120 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION


If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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 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: For 600 mg/60 mg: 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours For 1200 mg/120 mg: 1 extended-release tablet every 12 hours; not more than 2 extended-release 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 buler 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

Questions Or Comments?


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

Principal Display Panel 600 Mg And 60 Mg - Blister Foil Label




Principal Display Panel 600 Mg And 60 Mg - Blister Carton Label


NDC 62207-827-72 Compare To the active ingredients of Mucinex ® D

Guaifenesin and Pseudoephedrine Hydrochloride FOR DAY OR NIGHT

Extended-Release Tablets 12HR

600 mg and 60 mg

Guaifenesin 600 mg - Expectorant • Clears Nasal & Sinus Congestion Pseudoephedrine HCl 60 mg - Nasal Decongestant • Thins & Loosens Mucus • Immediate & Extended Release

RELIEVES NASAL & CHEST CONGESTION

90 (9x10) Extended-Release Tablets



Principal Display Panel 1200 Mg And 120 Mg - Blister Foil Label




Principal Display Panel 1200 Mg And 120 Mg - Blister Carton Label


NDC 62207-828-71 Compare To the active ingredients of Mucinex ® D

Guaifenesin and Pseudoephedrine Hydrochloride FOR DAY OR NIGHT Extended-Release Tablets 12HR

1200 mg and 120 mg

Guaifenesin 1200 mg - Expectorant • Clears Nasal & Sinus Congestion Pseudoephedrine HCl 120 mg - Nasal Decongestant • Thins & Loosens Mucus • Immediate & Extended Release

RELIEVES NASAL & CHEST CONGESTION

70 (7x10) Extended-Release Tablets



DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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