FDA Label for Allergy Relief

View Indications, Usage & Precautions

Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Kareway Product, 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 Tablet)



Diphenhydramine HCL 25mg


Purpose



Antihistamine


Uses



  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
      • sneezing
      • itchy, watery eyes
      • itching of the nose or throat
      • temporarily relieves these symptoms due to the common cold
        • runny nose
          • sneezing

Warnings



Do not use with any other product containing diphenhydramine, even one used on skin


Ask A Doctor Before Use If You Have



  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are



taking sedatives or tranquilizers


When Using This Product



  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • excitability may occur, especially in children
  • 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 right away.


Directions



  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
  • adults and children 12 years of age and over25 mg to 50 mg (1 to 2 tablets)
    children 6 to under 12 years of age12.5** to 25 mg (1 tablet)
    children under 6 years of ageask a doctor

    **12.5 mg dosage strength is not available in this package. Do not attempt to break tablets.


Other Information



  • each tablet contains:calcium 0.1mg
  • store at 59° to 77°F in a dry place
  • protect from light

Inactive Ingredients



microcrystalline cellulose, lactose anhydrous, sodium starch glycolate, pregelatinized starch, dibasic calcium phosphate dihydrate, crospovidone, stearic acid, magnesium stearate, hypromellose, polyethyleneglycol, titanium dioxide, ethanol


Package Label



Allergy Relief


* Please review the disclaimer below.