Severe Congestion And Cough Relief
FDA Label NDC 21130-817

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Safeway for the product Severe Congestion And Cough Relief (NDC 21130-817). 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 20 ml), purpose, uses, otc - keep out of reach of children, warnings, 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 20 Ml)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Phenylephrine HCl 10 mg


Purpose

Cough suppressant

Expectorant

Nasal decongestant

Uses

  • helps loosen phelgm (mucus) and thin bronchial secretions to drain bronchial tubes 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
  • nasal congestion due to a cold

Otc - Keep Out Of Reach Of Children


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 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

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

When Using This Product

  • do not use more than directed

Stop Use And Ask A Doctor If

  • nervousness, dizziness or sleeplessness occur
  • symptoms do not get better within 7 days or occur with fever
  • cough comes back, or occurs with rash or persistent headache. These 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.

Directions

  • do not take more than 6 doses in 24-hour period
  • measure only with dosing cup provided
  • do not use dosing cup  with other products
  • dose as follows or as directed by a doctor
  • Adults and children 12 years and older: 20 mL  in dosing cup provided every 4 hours
  • Children under 12 years of age: Do not use

Other Information

  • each 20 mL contains: sodium 20 mg
  • store between 15-30oC(59-86oF)
  • do not refrigerate
  • dosing cup provided

Inactive Ingredients

citric acid anhydrous, edetate disodium, FD&C blue 1, FD&C red 40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Principal Display Panel

compare to Mucinex Fast-Max Severe Congestion and Cough active ingredients

Maximum Strength severe congestion and cough relief

Dextromethorphan HBr 20 mg - cough suppressant

Guaifenesin 400 mg - expectorant

Phenylephrine HCl 10 mg - nasal decongestant

Relieves nasal and chest congestion,

Soothes cough,

Thins and loosens mucus

for ages 12 plus

6 fl oz (177 mL)

Label (Swsc617)

Label (Swsc617)

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