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  5. Label Information: Allergy Relief

FDA Label for Allergy Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    2. PURPOSE
    3. USES
    4. DO NOT USE
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. OVERDOSE WARNING
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. QUESTIONS OR COMMENTS?
    12. PRINCIPAL DISPLAY PANEL - CARTON LABEL

Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Puracap Pharmaceutical 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 Ingredient (In Each Softgel)



Diphenhydramine HCl 25 mg


Purpose



Antihistamine


Uses



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


Do Not Use



  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask A Doctor Before Use If You Have



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

When Using This Product



  • avoid alcoholic beverages and other drugs that cause drowsiness
  • drowsiness will occur
  • be careful when driving a motor vehicle or operating machinery

Overdose Warning



Taking more than directed can cause serious health problems. In case of 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 overtake 1 to 2 softgels 
    children 6 to under 12 years of agetake 1 softgel
    children under 6 years of age do not take this product in children under 6 years of age 


Other Information



  • store at room temperature 15°-30° C (59°-86° F) in a dry place
  • protect from heat, humidity, and light

Inactive Ingredients



gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, and white edible ink


Questions Or Comments?



Call toll free: 1-855-215-8180


Principal Display Panel - Carton Label



PuraVation Allergy Relief 

Diphenhydramine HCl - 25 mg EACH

12 LIQUID-FILLED SOFTGELS

NDC 51013-108-02


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