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  5. Label Information: Cetirizine Hydrochloride

FDA Label for Cetirizine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH TABLET)
    2. PURPOSE
    3. USES
    4. WARNINGS:
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - ASK DOCTOR/PHARMACIST
    8. WHEN USING THIS PRODUCT
    9. OTC - STOP USE
    10. IF PREGNANT OR BREAST-FEEDING:
    11. KEEP OUT OF REACH OF CHILDREN.
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS?
    16. OTHER
    17. CETIRIZINE HYDROCHLORIDE TABLETS USP 5 MG

Cetirizine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Rising Pharma Holdings, 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 Ingredients (In Each Tablet)



Cetirizine HCl USP 5 mg


Purpose



Antihistimine


Uses



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

  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat

Warnings:




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



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

Otc - Stop Use



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.

Keep Out Of Reach Of Children.



In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222)


Directions



Adults and children 6
 years and over		1 to 2 tablets once daily depending upon severity of symptoms; do not take more than 2 tablets in 24 hours.
Adults 65 years and over1 tablet once a day; do not take more than 1 tablet in 24 hours.
Children under 6 years of ageAsk a doctor
Consumers with liver or kidney diseaseAsk a doctor


Other Information



Store at 20° to 25°C (68° to 77°F)

[See USP Controlled Room Temperature].


Inactive Ingredients



hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.


Questions?



Call 1-866-562-4597


Other



Manufactured for:

Rising Pharmaceuticals, Inc.

Allendale, NJ 07401

Manufactured by:

Unique Pharmaceutical Labs,

(A Div. of J. B. Chemicals & Pharmaceuticals Ltd.),

Mumbai, INDIA.

M.L G/1430 Nov. 2016

120004


Cetirizine Hydrochloride Tablets Usp 5 Mg



Rising NDC 16571-401-10


Original Prescription Strength
Cetirizine Hydrochloride
Tablets 5 mg

Antihistamine 24 Hour Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose

100 Tablets
Allergy
Indoor & Outdoor
Allergies


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