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

Boxed Warning

Boxed Warning Section

Caution: do not use if imprinted seal under cap is broken or missing


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Boxed Warning Section


Caution: do not use if imprinted seal under cap is broken or missing

Otc - Active Ingredient Section


Drug Facts

Active Ingredients (per tablet)

Guaifenesin USP...................................... 400 mg

Dextromethorphan Hydrobromide USP...... 20 mg

Otc - Purpose Section


Purpose

Expectorant

Cough suppressant

Indications & Usage Section


Uses:
  • Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • Helps make coughs more productive.

Warnings Section


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 using 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 excessive phegm (mucus)

Stop use and ask a doctor if
  • Symptons are accompanied by fever, rash or persistent headache
  • cough persists for more than 1 week or tends to recur
  • A persistent cough may be a sign of a serious condition

If pregnant or breast-feeding, ask a healthcare 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 poison control center immediately

Dosage & Administration Section


Directions
  • Adults and children 12 years of age and over: take 1 tablet every 4 hours as needed
  • Children 6 to 12 years of age: take 1/2 tablet every 4 hours as needed
  • Children under 6 years of age: consult a doctor.

Do not exceed 6 doses in 24 hour period or as directed by a doctor

Storage And Handling Section


Other Information
  • store at 15°-30°C (59°-86°F)

Inactive Ingredient Section


Inactive Ingredients

Microcrystalline cellulose, Croscarmellose sodium, Povidone, silicon dioxide, magnesium stearate

Otc - Questions Section


Questions or concerns?
  • 1-855-642-2594


Distributed by:

APNAR PHARMA LP

CHINO, CA, 91710

Rev.: 04/2022

Package Label.principal Display Panel


APNAR PHARMA LP

NDC 24689-123-01

Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 + 20mg- 20s tablets



APNAR PHARMA LP

NDC 24689-123-02

Guaifenesin and Dextromethorphan Hydrobromide Tablets 400 + 20mg- 500s tablets



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"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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