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  5. Label Information: Cetirizine Hydrochloride

FDA Label for Cetirizine Hydrochloride

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT (IN EACH TABLET)
    3. PURPOSE
    4. USES
    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. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. QUESTIONS?
    16. PRINCIPAL DISPLAY PANEL - 10 MG TABLET BOTTLE LABEL

Cetirizine Hydrochloride Product Label

The following document was submitted to the FDA by the labeler of this product Redpharm Drug. 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: Ohm Laboratories Inc., New Brunswick, NJ 08901


Active Ingredient (In Each Tablet)



Cetirizine HCl, USP 10 mg


Purpose



Antihistamine


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

Otc - Do Not Use



Do not useif 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 haveliver 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 aretaking 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

Otc - Stop Use



Stop use and ask a doctor ifan 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 overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other Information



  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
  • store between 20° to 25° C (68° to 77° F)

Inactive Ingredients



corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide


Questions?



call 1-800-406-7984


Principal Display Panel - 10 Mg Tablet Bottle Label



NDC 51660-939-53

†Compare To
the active ingredient of
Zyrtec ®

ohm ®
Allergy Relief
Cetirizine HCl Tablets, USP 10 mg
ANTIHISTAMINE
Indoor & Outdoor Allergies

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

300 TABLETS
10 mg EACH

24
Hours

Original Prescription Strength

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label - ohm cetrizine 01

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label - ohm cetrizine 01


* Please review the disclaimer below.