Allergy Relief
FDA Label NDC 51013-108

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 Allergy Relief (NDC 51013-108). 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, overdose warning, directions, 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:
   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?

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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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