FDA Label for Pharbinex-pe

View Indications, Usage & Precautions

Pharbinex-pe Product Label

The following document was submitted to the FDA by the labeler of this product Ulai Health Llc. 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



  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
  • helps to make cough more productive
  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • promotes nasal and/or sinus drainage
  • temporarily relieves sinus congestion and pressure

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 an enlarged prostate gland
  • cough accompanied by too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - When Using



When using this product do not exceed recommended dosage.


Stop Use And Ask A Doctor If



  • nervousness, dizziness or sleeplessness occurs
  • symptoms do not improve within 7 days, or are accompanied by a fever
  • cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, persistent headache
  • These could be sings 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 the meals
  • do not exceed 6 doses in 24 hours or as directed by a 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

    ask a doctor


Other Information



store at 200- 250C (680-770F)


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 Or Comments?



(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)


Other



TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:

ULAI HEALTH LLC.

Alexandria, VA 22312


Package Label.Principal Display Panel



PHARBEST 

NDC 73057-389-04

Manufactured in the USA

Immediate Release

PHARBINEX-PE

Guaifenesin 400mg

Phenylephrine HCl 10mg

Expectorant & 

Nasal Decongestant

30 CAPLETS


* Please review the disclaimer below.