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  5. Label Information: Valurx Dye Free Allergy Relief

FDA Label for Valurx Dye Free Allergy Relief

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH SOFT GEL)
    3. PURPOSE
    4. USES
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGRADIENT
    14. QUESTIONS OR COMMENTS?
    15. OTHER
    16. PRINCIPAL DISPLAY

Valurx Dye Free Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Shield Pharmaceuticals Corp. 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.

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, isopropyl alcohol*, light mineral oil*, polyethylene glycol-400, propylene glycol, povidone, purified water, sorbitol sorbitan solution *may contain this ingredient


Questions Or Comments?



1-800-373-6981


Other



Distributed by:

Shield Pharmaceuticals Corp.

Ronkonkoma, NY 11779


* Please review the disclaimer below.