FDA Label for Pharbedryl

View Indications, Usage & Precautions

Pharbedryl 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 Ingredient(In Each Banded Capsule)



Diphenhydramine HCl 50 mg


Purpose



Antihistamine


Uses:



  • Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies:
  •                     -Sneezing
                        -Nasal congestion
                        -Runny nose
                        -Itchy, watery eyes

Do Not Use



  • With any other product containing diphenhydramine, even one used on skin.

Ask A Doctor Before Use If You Have



  • Trouble urinating due to enlarged prostate gland
  • A breathing problem such as emphysema or chronic bronchitis
  • Glaucoma

Ask Doctor Or Pharmacist Before Use If You Are



Taking sedatives or tranquilizers

When Using This Product



  • Avoid alcoholic drinks
  • Marked drowsiness may occur.
  • Excitability may occur, especially in children
  • Alcohol, sedatives and tranquilizers may increase drowsiness
  • Be careful when driving a motor vehicle or operating machinery

If Pregnant Or Breast-Feeding,



Ask a health professional before use.

Keep Out Of Reach Of Children.



In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Directions:



  • Take every 4-6 hours
  • Do not take more than 6 doses in 24 hours.
  • Adults and children 12 years or over
    1 capsule                                     
    Children under 12 years
    ask a doctor

Other Information:



  • Tamper Evident: Do not use if safety seal under cap is broken or missing
  • Store at room temperature 15°-30°C (59°-86°F)
  • Protect from moisture
  • Use by expiration date on package

Questions? Adverse Drug Event Call:



(866) 562-2756


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