FDA Label for Equate Allergy Relief

View Indications, Usage & Precautions

Equate Allergy Relief Product Label

The following document was submitted to the FDA by the labeler of this product Wal-mart Stores, Inc.. 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)



Cetirizine HCl 10 mg


Purpose



Antihistamine


Uses



temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy throat or nose

Otc - Do Not Use



Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.


Otc - Ask Doctor



Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.


Otc - Ask Doctor/Pharmacist



Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.


When Using This Product



  • drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery.

Stop Use And Ask A Doctor If



an allergic reaction to this product occurs. Seek medical help right away.


If Pregnant Or Breast-Feeding:



  • if breast-feeding: not recommended
  • if pregnant: 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



adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and over ask a doctor
children under 6 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

Other Information



  • do not use if printed foil under cap broken or missing
  • store between 20° to 25°C (68° to 77°F)

Inactive Ingredients



Colloidal silicon dioxide, Hypromellose, lactose monohydrate, low-substituted hydroxyporpyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and titanium dioxide.


Questions Or Comments?



1-888-287-1915


Principal Display Panel - Carton Label



NDC 49035-312-56

equate

Allergy Relief

Cetirizine Hydrochloride Tablets USP, 10 mg
Antihistamine

Indoor and Outdoor Allergies

24 Hour Relief of:

  • Sneezing
  • Runny nose
  • Itchy, watery eyes
  • Itchy throat or nose
  • 24
    HOUR
    SYMPTOM

    RELIEF

    Original Prescription Strength

    10 mg

    14 TABLETS

    NDC 49035-312-57

    equate

    Allergy
    Relief

    Cetirizine Hydrochloride
    Tablets USP, 10 mg/Antihistamine

    Indoor and Outdoor Allergies

    24 Hour Relief of:

    • Sneezing
    • Runny nose
    • Itchy, watery eyes
    • Itchy throat or nose
    • 24
      HOUR
      SYMPTOM

      RELIEF

      Original
      Prescription Strength

      10 mg

      45 TABLETS

      NDC 49035-312-05

      equate

      Allergy
      Relief

      Cetirizine Hydrochloride
      Tablets USP, 10 mg/Antihistamine

      Indoor and Outdoor Allergies

      24 Hour Relief of:

      • Sneezing
      • Runny nose
      • Itchy, watery eyes
      • Itchy throat or nose
      • 24
        HOUR
        SYMPTOM

        RELIEF

        Original
        Prescription Strength

        10 mg

        90 TABLETS

        NDC 49035-312-58

        equate

        Allergy Relief

        Cetirizine Hydrochloride
        Tablets USP,
        10 mg/Antihistamine

        Indoor and
        Outdoor Allergies

        24 Hour Relief of:

        • Sneezing
        • Runny nose
        • Itchy, watery eyes
        • Itchy throat or nose
        • 24
          HOUR
          SYMPTOM

          RELIEF

          Original Prescription Strength

          10 mg

          180 TABLETS


Principal Display Panel - Bottle Label



equate

NDC 49035-312-57

Allergy Relief

Cetirizine Hydrochloride
Tablets USP, 10 mg

Antihistamine

Original
Prescription
Strength

45 Tablets

equate

NDC 49035-312-05

Allergy Relief

Cetirizine Hydrochloride
Tablets USP, 10 mg

Antihistamine

Original
Prescription
Strength

90 Tablets


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