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CETIRIZINE HYDROCHLORIDE (cetirizine hydrochloride 10 mg) Dailymed

  1. Human OTC
  2. Histamine-1 Receptor Antagonist
  3. Aphena Pharma Solutions - Tennessee, LLC

Generic: cetirizine hydrochloride is used for the treatment of Rhinitis, Allergic, Perennial Urticaria

CETIRIZINE HYDROCHLORIDE tablet, film coated - (cetirizine hydrochloride 10 mg) image

IMPRINT: 10MG APO     SHAPE: rectangle
    COLOR: white

  1. FDA Adverse Reactions

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Active Ingredient (in Each Tablet)


Cetirizine HCl, USP 10

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

Warnings


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.

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 SECTION


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 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.

.


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

  • store between 20° and 25°C (68° - 77°F)
  • do not use if seal under bottle cap is broken or missing
  • meets USP Dissolution Test 3

Inactive Ingredients


carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, starch (corn) and titanium dioxide.

Otc - Questions Section


Call 1-800-706-5575, weekdays, 8:30am - 5:00pm Eastern Standard Time

Repackaging Information


Please reference the How Supplied section uled above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are uled below:
Count 10 mg
90 71610-048-60

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by: Cookeville, TN 38506 20180418JH

Principal Display Panel - 10 Mg


NDC 71610-048 - Cetirizine HCl 10 mg

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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