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Guaifenesin and Pseudoephedrine HCl (guaifenesin 600 mg pseudoephedrine hcl 60 mg tablet, extended release) Dailymed


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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guaifenesin 1200 mg pseudoephedrine hcl 120 mg tablet, extended release - 057 oval white

guaifenesin 600 mg pseudoephedrine hcl 60 mg tablet, extended release - 058 oval white

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Otc - Active Ingredient Section


OTC - PURPOSE SECTION


Active ingredients (in each extended-release bi-layer tablet)

Purposes

Guaifenesin 600 mg

Expectorant

Pseudoephedrine HCl 60 mg

Nasal Decongestant

Active ingredients (in each extended-release bi-layer tablet)

Purposes

Guaifenesin 1200 mg

Expectorant

Pseudoephedrine HCl 120 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 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 tablet
  • •take with a full glass of water
  • •this product can be administered without regard for timing of meals
  • • For 600 mg/60 mg: adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours
  • • For 1200 mg/120 mg: adults and children 12 years and older: 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 buler is broken or missing.
  • •store between 20-25°C (68-77°F)

Inactive Ingredients


carbomer homopolymer, NF; FD&C Yellow #6; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF

Questions?


call 1-800-406-7984

You may also report side effects to this phone number.

Keep the carton. It contains important information.

See end panel for expiration date.

†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

Distributed by:Ohm Laboratories Inc.New Brunswick, NJ 08901

0219

Guaifenesin 600 Mg And Pseudoephedrine Hcl 60 Mg Extended-release Bi-layer Tablets - Carton Label


NDC 51660-058-18

†Compare To the active ingredients of Mucinex® D

ohm®

Guaifenesin 600 mg & Pseudoephedrine HCl 60 mg Extended-Release Bi-Layer Tablets

Expectorant & Nasal Decongestant

12 Hour
  • • Clears Nasal/Sinus Congestion
  • • Thins and Loosens Mucus
  • • Immediate and Extended Release

18 Extended-Release Bi-Layer Tablets

†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

Guaifenesin 1200 Mg And Pseudoephedrine Hcl 120 Mg Extended-release Bi-layer Tablets - Carton Label


NDC 51660-057-12

†Compare To the active ingredients of Mucinex® D

ohm®

Maximum Strength Guaifenesin 1200 mg & Pseudoephedrine HCl 120 mg Extended-Release Bi-Layer Tablets

Expectorant & Nasal Decongestant

12 Hour
  • • Clears Nasal/Sinus Congestion
  • • Thins and Loosens Mucus
  • • Immediate and Extended Release

12 Extended-Release Bi-Layer Tablets

†Ohm® is a registered trademark of Sun Pharmaceutical Industries, Inc. All other trademarks are property of their respective owners.

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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