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  5. Label Information: Pecgen Pse Cough Suppressant Expectorant Nasal Decongestant Grape Flavor

FDA Label for Pecgen Pse Cough Suppressant Expectorant Nasal Decongestant Grape Flavor

View Indications, Usage & Precautions

Table of Contents

    1. PECGEN PSE COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT
    2. ACTIVE INGREDIENTS (IN EACH 5 ML TEASPOONFUL)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE IF
    7. ASK A DOCTOR BEFORE USE IF
    8. WHEN USING THIS PRODUCT
    9. STOP USE AND ASK A DOCTOR IF
    10. IF PREGNANT OR BREAST-FEEDING,
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. PECGEN PSE COUGH SUPPRESSANT EXPECTORANT NASAL DECONGESTANT

Pecgen Pse Cough Suppressant Expectorant Nasal Decongestant Grape Flavor Product Label

The following document was submitted to the FDA by the labeler of this product Kramer Novis. 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.

Pecgen Pse Cough Suppressant Expectorant Nasal Decongestant




Active Ingredients (In Each 5 Ml Teaspoonful)



Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 187 mg
Pseudoephedrine HCl, USP 30 mg


Purpose



Cough suppressant
Expectorant
Nasal decongestant


Uses



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

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
  • difficulty in urination due to enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

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 improve within 7 days or are acompanied by fever
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could 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 4 doses in any 24-hour period

EVERY 4 HOURS

 Adults and children 12 years of age and older:

10 mL (2 tsp.)

 Children 6 to under 12 years of age:

5 mL (1 tsp.)

 Children 2 to under 6 years of age:

2.5 mL (½ tsp)

 Children under 2 years of age:

Consult physician


Other Information



  • Tamper evident: Do not use this product if breakaway band on cap is broken or missing.
  • Store at room temperature 15°C-30°C (59°F-86°F)
  • Avoid excessive heat or humidity.
  • Each teaspoon (5 mL) contains: Sodium 16 mg

Inactive Ingredients



Citric acid, Flavor, Glycerin, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol.


Pecgen Pse Cough Suppressant Expectorant Nasal Decongestant




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