Cough Suppressant And Expectorant Dm
FDA Label NDC 70005-044

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by We Care Distributor Inc. for the product Cough Suppressant And Expectorant Dm (NDC 70005-044). 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, purpose, uses, warnings, ask a doctor before use if, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 100 mg

Purpose

Cough suppressant
Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with cold. It helps helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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 taking this product.

Ask A Doctor Before Use If

  • cough that occurs with too much phlegm (mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Stop Use And Ask A Doctor If

cough lasts more than 7 days, comes back, or accompanied by fever, rash, or persistant headache.

These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of The Reach Of Children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Directions

  • Do not take more than 6 doses in a 24-hour period
  • Repeat dose every 4 hours while symptoms last

    •           AGE                                     DOSE

    adults and children

    12 years of age and over               10 mL    

    children 6 years to

    under 12 years of age                    5 mL

    children 2 years to

    under 6 years of age                      2.5 mL

    children under

    under 2 years of age                      ask a doctor

Other Information

  • Store at 15-30°C (59-86°F)
  • Protect from freezing
  • Alcohol free
  • Protect from light
  • Each teaspoon 5mL contains: Sodium 3 mg

Inactive Ingredients

citric acid, dextrose**, flavor, FD&C red #40, glucose, glycerin, high fructose corn syrup, menthol, purified water, saccharin sodium,
sodium benzoate

** contains one or more of these ingredients

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Compare to the Active Ingredients in Robitussin DM

Dextromethorphan HBr, 10 mg - guaifenesin, 100 mg

cough suppressant, expectorant

Non-Drowsy

Alcohol Free

Relieves- coughs, chest congestion and mucus

2 FL Oz (60 mL)

* Please review the disclaimer below.