1. Home
  2. Labeler Index
  3. Safrel Pharmaceuticals, Llc.
  4. 71309-009
  5. Label Information: Allergy Relief

FDA Label for Allergy Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. IF PREGNANT OR BREAST-FEEDING;
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Allergy Relief Product Label

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

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

Warnings



Do not use

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

    • Ask a doctor before use if you have

    • trouble urinating due to an enlarged prostate gland
    • glaucoma ? a breathing problem such as emphysema or chronic bronchitis

      • Ask a doctor or pharmacist before use if youare taking sedatives or tranquilizers

      When using this product

      • marked drowsiness may occur
      • avoid alcoholic drinks
      • excitability may occur, especially in children ? alcohol, sedatives and tranquilizers may increase drowsiness
      • be careful when driving a motor vehicle or operating machinery

If Pregnant Or Breast-Feeding;



ask a health professional before use


Keep Out Of Reach Of Children.



In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage.


Directions



  • take every 4 to 6 hours, not more than 6 doses in 24 hours
  • Adults and children 12 years of age and older: 1 or 2 tablets
  • children 6 to under 12 years of age: 1 tablet
  • children 4 to under 6 years of age: do not use unless directed by a doctor
  • children under 4 years of age: do not use

Other Information



  • each tablet contains : calcium 20 mg
  • store at controlled room temperature 20°-25°C (68°-77°F).
  • read all product information before using.
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Inactive Ingredients



Colloidal silicon Dioxide, Croscarmellose Sodium, Dicalcium Phosphate, D & C Red, Magnesium stearate, Microcrystalline cellulose, Polyvinyl alcohol, Titanium dioxide, Talc


* Please review the disclaimer below.