Guaifenesin And Dextromethorphan Hbr Tablet, Extended Release
FDA Label NDC 63304-106

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sun Pharmaceutical Industries, Inc. for the product Guaifenesin And Dextromethorphan Hbr (NDC 63304-106). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients (in each extended-release tablet), purposes, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (In Each Extended-Release Tablet)

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

Spl-guai-dextro-label (Image 01)

Spl-guai-dextro-label (Image 01)

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

Spl-guai-dextro-label2 (Spl Guai Dextro Label2)

Spl-guai-dextro-label2 (Spl Guai Dextro Label2)

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