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  5. Label Information: Dometuss-dmx

FDA Label for Dometuss-dmx

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTSACTIVE INGREDIENTS (IN EACH 5 ML TEASPOONFUL) CONTAINS
    2. PURPOSE
    3. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
    4. USES
    5. WARNINGS - DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. IF PREGNANT OR BREAST-FEEDING
    8. STOP USE AND ASK A DOCTOR IF
    9. DIRECTIONS
    10. INACTIVE INGREDIENTS
    11. OTHER INFORMATION
    12. QUESTIONS OR COMMENTS?
    13. DOMETUSS-DMX PRODUCT LABEL

Dometuss-dmx Product Label

The following document was submitted to the FDA by the labeler of this product Domel Laboratories. 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.

Drug Factsactive Ingredients (In Each 5 Ml Teaspoonful) Contains



Guaifenesin 200mg

Dextromethorphan HBr, USP 30 mg

Phenylephrine HCL, USP 10 mg


Purpose



Expectorant

Cough suppressant

Nasal decongestant


Keep This And All Drugs Out Of The Reach Of Children.



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


Uses



  • Helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
  • Temporarily relieves these symptoms occuring with a cold: nasal congestion, cough due to minor throat and bronchial irritation

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



  • Heart Disease
  • High Blood Pressure
  • Thyroid Disease
  • Diabetes
  • Trouble urinating due to an enlarged prostate gland
  • Cough that occurs with too much phlegm (mucus)
  • Cough that lasts or is chronic such as bronchitis or emphysema

If Pregnant Or Breast-Feeding



as a health professional before use.


Stop Use And Ask A Doctor If



  • You get nervous, dizzy, or sleepless
  • Symptoms do not get better within 7 days or are accompanied by a fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistant headache.

    • These could be signs of a serious condition.


Directions



  Do not exceed recommended dosage

Do not take more than 4 doses in any 24-hour period

 

 
 age dose
 Adults and children 12 years of age and older 1 teaspoon every 6 hours
 Children under 12 years of age ask a doctor

 


Inactive Ingredients



Artificial grape flavor, citric acid, D&C red #33, FD&C blue #1, glycerin, methyl paraben, propylene glycol, propyl paraben, purified water, sodium citrate, sucralose.


Other Information



• Store at 15°-30° C (59°-86°F)


Questions Or Comments?



Please call (787) 767-3246


Dometuss-Dmx Product Label



NDC 53809-203-01

DOMETUSS-DMX

COUGH SUPPRESSANT/EXPECTORANT/NASAL DECONGESTANT

Alcohol and Sugar

FREE

Grape Flavor

1 Fl. Oz. (30 mL)

Rev: 12/12

Tamper-Evident Disclosure: Do not use if there is evidence of tampering.

LOT#:/EXP.DATE:

Manufactured for:

DOMEL

SAN JUAN, PUERTO RICO 00924


* Please review the disclaimer below.