Dye-free Allergy
FDA Label NDC 51013-144

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puracap Pharmaceutical Llc for the product Dye-free Allergy (NDC 51013-144). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each softgel), purpose, uses, do not use, ask a doctor before use if you have, when using this product, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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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.