1. Home
  2. Labeler Index
  3. Shield Pharmaceuticals Corp
  4. 83059-0021
  5. Label Information: Allergy Relief

FDA Label for Allergy Relief

View Indications, Usage & Precautions

Table of Contents

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

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.

Other



Drug Facts

Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788


Active Ingredient (In Each Liquid-Filled Capsule)



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


Warnings




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 useif you are taking 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 (1-800-222-1222) right away.


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 tablets
    children 6 to under 12 years1 tablet
    children under 6 yearsdo not use


Other Information



  • each tablet contains:calcium 25 mg
  • store between 20-25° C (68-77° F)
  • protect from moisture and light

Inactive Ingredients



  • each tablet contains: calcium 60 mg
  • store in a dry place at 15° – 30°C (59° – 86°F)
  • do not use if imprinted seal under cap is broken or missing

    • dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, FD&C red #3, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide


Questions Or Comments?



1-800-373-6981


Principal Display Panel



Allergy Relief

Diphenhydramine HCl 25 mg


Carton

Label


* Please review the disclaimer below.