Valurx Dye Free Allergy Relief Capsule, Liquid Filled
FDA Label NDC 83059-0080

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Valurx Dye Free Allergy Relief (NDC 83059-0080). 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 drug facts, active ingredient (in each soft gel), purpose, uses, do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient (In Each Soft Gel)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose 
  • itchy, watery eyes
  • sneezing 
  • 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 
  • trouble urinating due to an enlarged
  • prostate gland 
  • glaucoma

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you aretaking sedatives or tranquilizers

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours

    adults and children 12 years and over1 to 2 softgels
    children 6 to under 12 years1 softgel
    children under 6 years do not use

Other Information

  • store between 20-25° C (68-77° F)
  • Avoid high humidity and excessive heat
  • protect from moisture and light

Inactive Ingradient

gelatin, glycerin, polyethylene glycol-400, propylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions Or Comments?

1-800-373-6981

Other

Distributed by:

Shield Pharmaceuticals Corp.

Ronkonkoma, NY 11779

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