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  5. Label Information: Trispec Dmx Pediatric Drops Cough Suppressant Expectorant Cherry Raspberry Flavor

FDA Label for Trispec Dmx Pediatric Drops Cough Suppressant Expectorant Cherry Raspberry Flavor

View Indications, Usage & Precautions

Table of Contents

    1. TRISPEC DMX PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR
    2. ACTIVE INGREDIENTS (IN EACH 5 ML TEASPOONFUL)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. ASK A DOCTOR BEFORE USE IF THE CHILD HAS
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. TRISPEC DMX PEDIATRIC DROPS COUGH SUPPRESSANT EXPECTORANT CHERRY RASPBERRY FLAVOR 2OZ/60ML (58238-229-02)

Trispec Dmx Pediatric Drops Cough Suppressant Expectorant Cherry Raspberry Flavor Product Label

The following document was submitted to the FDA by the labeler of this product Deliz Pharmaceutical Corp. 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.

Trispec Dmx Pediatric Drops Cough Suppressant Expectorant Cherry Raspberry Flavor





Active Ingredients (In Each 5 Ml Teaspoonful)



Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 187 mg


Purpose



Cough suppressant
Expectorant


Uses



  • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold or inhaled irritants
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings





Do Not Use




in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.


Ask A Doctor Before Use If The Child Has



  • persistent or chronic cough such as occurs with asthma
  • cough accompanied by excessive phlegm (mucus)

Stop Use And Ask A 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.

Keep Out Of Reach Of Children.



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


Directions



  • For children under 6 years of age, use enclosed dropper
  • do not use enclosed dropper for any other drug product
    • Children 2 to under 6 years of age:
    		2.5 mL every 4 hours not to exceed 15 mL in 24 hours, or as directed by a doctor
    Children under 2 years of age:
    		Consult a doctor.

Other Information



  • Store at room temperature 15°C-30°C (59°F-86°F)

Inactive Ingredients



cherry flavor, citric acid, glycerin, methylparaben, monoammonium glycyrrhizinate, potassium citrate, potassium sorbate, propylparaben, propylene glycol, purified water, raspberry flavor, sorbitol, sucralose


Questions?



Call 1-787-701-3312. You may also report serious side effects to this phone number.


Trispec Dmx Pediatric Drops Cough Suppressant Expectorant Cherry Raspberry Flavor 2Oz/60Ml (58238-229-02)



Trispec DMX 1 - TrispecDMX1

Trispec DMX 1 - TrispecDMX1


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