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  5. Label Information: Valumeds Allergy Relief

FDA Label for Valumeds Allergy Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    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 INGREDIENTS
    14. QUESTIONS OR COMMENTS?
    15. PRINCIPAL DISPLAY PANEL - 600 CT BOTTLE LABEL

Valumeds Allergy Relief Product Label

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

Other



Drug Facts

*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Benadryl®.

Distributed By:

Spirit Pharmaceuticals, LLC

Ronkonkoma, NY 11779

ORIG 06/17


Active Ingredient (In Each Tablet)



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 are

taking 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 of age and over1 to 2 tablets
    children 6 to under 12 years of age1 tablet
    children under 6 years of agedo not use this product in children under 6 years of age


Other Information



  • each tablet contains calcium 24 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • protect from moisture and light

Inactive Ingredients



colloidal silicon dioxide, croscarmellose sodium, D&C red No 27, dicalcium phosphate, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide


Questions Or Comments?



1-888-333-9792


Principal Display Panel - 600 Ct Bottle Label



VALUMEDS™

Compare to the active ingredient in  Benadryl® Allergy Tablets*

ALLERGY RELIEF 

Antihistamine 
Diphenhydramine HCl 25 mg

For the temporary relief of:

  • Runny Nose 
  • Sneezing,
  • Itchy Throat 
  • Itchy, Watery Eyes

    • 600 TABLETS


* Please review the disclaimer below.