Guaifenesin And Dextromethorphan Hbr Tablet, Extended Release
FDA Label NDC 43598-115

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr. Reddy's Laboratories Inc. for the product Guaifenesin And Dextromethorphan Hbr (NDC 43598-115). 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, purposes, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, 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)

Guaifenesin USP, 600 mg

Dextromethorphan Hydrobromide USP, 30 mg

Guaifenesin USP, 1200 mg

Dextromethorphan Hydrobromide USP, 60 mg

Purposes

Expectorant

Cough suppressant

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.

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
  • children under 12 years of age: do not use

    • For 600 mg/30 mg:

    • adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours.

      • For 1200 mg/60 mg:

      • adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours.

Other Information

  • store at 20°C to 25°C (68°F to 77°F)

Inactive Ingredients

carbomer homopolymer type B, colloidal silicon dioxide, FD & C Blue #1, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.

Questions

call 1-888-375-3784 Weekdays (9am - 8pm EST)

You may also report side effects to this phone number.

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