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  5. Label Information: Dye Free Allergy Relief

FDA Label for Dye Free Allergy Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH SOFTGEL)
    3. PURPOSE
    4. USES
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. QUESTIONS OR COMMENTS?
    14. INACTIVE INGREDIENTS
    15. PRINCIPAL DISPLAY PANEL

Dye Free Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Topco Associates, 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

Distributed by:
Topco Associates LLC
Itasca, IL 60143


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
  • itchy, watery eyes
  • sneezing
  • itching of the nose or throat
  • temporarily relieves these symptoms due to the common cold: 
  • runny nose
  • sneezing

Otc - Do Not Use



Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Otc - Ask Doctor



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


Otc - When Using



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 & children 12 yrs & over1 to 2 Softgels
    children 6 to under 12 yrs1 Softgel
    children under 6 yrsdo not use


Other Information



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

Questions Or Comments?



1-800-373-6981 (toll-free)


Inactive Ingredients



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


Principal Display Panel



TopCare health

Dye-Free
Allergy Relief

Diphenhydramine HCl 25 mg


Relieves

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

    • Diphenhydramine HCl 25 mg
    No artificial flavors
    No synthetic colors
    Gluten free*
    Non-GMO

    Carton


* Please review the disclaimer below.