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


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guaifenesin and dextromethorphan hbr tablet, extended release - 053 oval white

guaifenesin and dextromethorphan hbr tablet, extended release - 054 oval white

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Active Ingredients


Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

Purposes


Cough suppressant

Expectorant

Uses

  • •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
  • •temporarily relieves:
  • •cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • •the intensity of coughing
  • •the impulse to cough to help you get to sleep

Warnings


Do not use
  • •for children under 12 years of age
  • •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

  • •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

  • •cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Pregnancy or Breast Feeding


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: 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

  • •Store between 20-25°C (68-77°F)

Inactive Ingredients


carbomer homopolymer, colloidal silicon dioxide, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), stearic acid

Package/label Principal Display Panel


NDC 63304-110-14

Maximum Strength

Guaifenesin & Dextromethorphan HBr Extended-Release Tablets

1200 mg/60 mg

Expectorant & Cough Suppressant

12 Hour

• Controls Cough

• Thins and Loosens Mucus

• Immediate and Extended Release

14 Extended-Release Tablets

SUN PHARMA

Package/label Principal Display Panel


NDC 63304-106-21

Guaifenesin & Dextromethorphan HBr Extended-Release Tablets

600 mg/30 mg

Expectorant & Cough Suppressant

12 Hour

• Controls Cough

• Thins and Loosens Mucus

• Immediate and Extended Release

20 Extended-Release Tablets

SUN PHARMA

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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