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  5. Label Information: Pharbinex-pe

FDA Label for Pharbinex-pe

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH CAPLET)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pharbinex-pe Product Label

The following document was submitted to the FDA by the labeler of this product Pharbest Pharmaceuticals, Inc.. 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 (In Each Caplet)



Guaifenesin 400mg

Phenylephrine HCl 10mg


Purpose



Expectorant

Nasal Decongestant


Uses



Temporarily relieves symptoms associated with cough, the common cold, hay fever or upper respiratory allergies

  • helps loosen phlegm(mucus)
  • thin bronchial secretions
  • drain bronchial tubes
  • make coughs more productive
  • loosen nasal congestion
  • clear stuffy nose
  • clear nasal passageways
  • shrinks swollen membranes

Warnings



Do not exceed recommended dosage.

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 MAOI drug. If you do not know whether your prescription drug contains an MAOI, ask your doctor or pharmacist before using this product.


Ask A Doctor Before Use If You Have



  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • excessive phlegm (mucus)
  • difficulty in urination due to enlargement of prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop Use And Ask A Doctor If



  • nervousness, dizziness or sleeplessness occurs
  • symptoms are accompanied by fever, rash or persistent headache
  • cough and congestion do not improve within 7 days or tend to recur

    • These could be signs of a serious illness.


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 (1-800-222-1222).


Directions



  • take with a full glass of water
  • this product can be administered without regard for the timing of meals
  • do not exceed 6 doses in 24 hours or as directed by doctor

    • adults and children 12 years of age and over

    take 1 caplet every 4 hours as needed

    children 6 to under 12 years of age

    take ½ caplet every 4 hours as needed

    children under 6 years of age

    consult a doctor


Other Information



  • store at room temperature (15°-30°C)

Inactive Ingredients



croscarmellose sodium, hypromellose, lactose, magnesium stearate, maltodextrin, microcrystalline celluclose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide, triacetin


Questions?



Adverse drug event call (866) 562-2756 Mon-Fri: 8 AM to 4 PM


Package Label.Principal Display Panel



PHARBEST 

NDC 16103-0389-04

Manufactured in the USA

Immediate Release

PHARBINEX-PE

Guaifenesin 400mg & Phenylephrine HCl 10mg

Expectorant & Nasal Decongestant

30 CAPLETS


* Please review the disclaimer below.