First Aid Direct Cough Relief Dm
FDA Label NDC 42961-121

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cintas Corporation for the product First Aid Direct Cough Relief Dm (NDC 42961-121). 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 (each 5ml/1 teaspoon), purposes, uses, warnings, stop use and ask doctor if, if pregnant or breast-feeding,, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients (Each 5Ml/1 Teaspoon)

  • Dextromethorphan HBr 10mg
  • Guaifenesin 100 mg

Purposes

cough suppressant

expectorant

Uses

temporarily:

  • relieves coughing due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Do not use

this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. 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 are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product.

Stop Use And Ask Doctor If

  • cough persists for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign 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 hours, or as directed by a doctor.

  • adults and children 12 years and over, take one premeasured single dose dispenser (2 teaspoons) every 4 hours
  • children 6-11 years, measure out and take only 1 teaspoon every 4 hours
  • children 2 to 5 years, measure out and take only 1/2 teaspoon every 4 hours
  • children under 2 years, consult your doctor

Other Information

  • do not use if dispenser is torn, cut or opened
  • store at room temperature
  • avoid excessive heat and humidity

Inactive Ingredients

citric acid, FD&C red 40, flavor, glycerin, methyl paraben, propylene glycol, propyl paraben, purified water, sodium citrate, sucralose

Questions?

1-800-327-2704

Package Label Principal Display Panel Single Dose Pack

BEND HERE 

AND TEAR

Cough Relief DM

COUGH SUPPRESSANT EXPECTORANT

1/3 FL OZ (10 mL)

(2 Teaspoons)

Pouch (Pouch)

Pouch (Pouch)

Pouch (Pouch)

Pouch (Pouch)

Package Label Principal Display Panel Box

Cough Relief DM

COUGH SUPPRESSANT

EXPECTORANT

LIQUID COUGH FORMULA

  • CONTROLS COUGHS
  • LOOSENS and RELIEVES CHEST CONGESTIONS
  • ALCOHOL-FREE
  • NON DROWSY FORMULA

    • 6-10mL Doses per Box

    Box (Box)

    Box (Box)

* Please review the disclaimer below.