Cough And Congestion Dm
FDA Label NDC 58805-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Agile Pharmachem for the product Cough And Congestion Dm (NDC 58805-007). 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 ingredient, purpose, uses, directions, warnings, keep out of reach of children., other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

(in each liquid filled capsule)

Dextromethorphan Hydrobromide, USP 10mg

Guaifenesin, USP 200mg

Purpose

Cough Suppressant

Expectorant

Uses

  • Temporarily relieves cough due minor throat and bronchial irritation as may occur with a cold
  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Directions

  • Do not take more than 12 capsules in any 24 hour period
  • This adult product is not intend for use in children under 12 years of age
                               Age              dose
    Adults and children 12 years and over2 capsules every 4 hours
    Children under 12 yearsDo not use

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 you have

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

    Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. This could be signs of a serious condition.

    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.

Other Information

  • store at 20-25 °C(68-77 °F)
  • avoid excessive heat above 40 °C (104°F)

Inactive Ingredients

FD&C Red No 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, providone (PVP K-30), purified water, special sorbitol, titanium dioxide

Questions Or Comments

Toll free 1-855-314-1850

Package Label.Principal Display Panel

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4e88b254-figure-01 (4e88b254 Figure 01)

Cough and Congestion DM,

NDC:58805-007-75  25*300 Softgel Liquid filled

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