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  5. Label Information: Dye-free Allergy

FDA Label for Dye-free Allergy

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. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?
    11. PRINCIPAL DISPLAY PANEL

Dye-free Allergy 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:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
    • temporarily relieves these symptoms due to the common cold:
      • runny nose
      • 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



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

When Using This Product



  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Directions



  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours

    • adults and children 12 years and over

         1 to 2 softgels

    children 6 to under 12 years

         1 softgel

    children under 6 years

         do not use 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: 1-800-833-6278


Principal Display Panel



DYE-FREE ALLERGY 24 SOFTGELS

Diphenhydramine HCl 25mg

NDC 51013-144-04

*Compare to the active ingredient in Benadryl® Dye-Free Allergy Liqui-Gels®


* Please review the disclaimer below.