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  5. Label Information: First Aid Direct Cough Relief Dm

FDA Label for First Aid Direct Cough Relief Dm

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (EACH 5ML/1 TEASPOON)
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. STOP USE AND ASK DOCTOR IF
    6. IF PREGNANT OR BREAST-FEEDING,
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS?
    12. PACKAGE LABEL PRINCIPAL DISPLAY PANEL SINGLE DOSE PACK
    13. PACKAGE LABEL PRINCIPAL DISPLAY PANEL BOX

First Aid Direct Cough Relief Dm Product Label

The following document was submitted to the FDA by the labeler of this product Cintas Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.