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


IMPRINT: M C37     SHAPE: round
    COLOR: white

All Imprints

cetirizine hydrochloride 10 mg - m c37 round white

cetirizine hydrochloride 5 mg - m c35 round white

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CETIRIZINE HCl 10 mg TABLETS, USP

Antihistamine

Indoor & Outdoor Allergies

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Active Ingredient (in Each Tablet)


Cetirizine Hydrochloride, 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

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.

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.

Keep out of reach of children.


In case of overdose, get medical help or contact a Poison Control Center right away.

Directions (24 Hour Relief)


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 at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Inactive Ingredients


Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin

Questions? 1-800-848-0462

  • Serious side effects associated with use of this product may be reported to this number.

How Supplied


Cetirizine Hydrochloride Tablets, USP are available as follows:

10 mg - White, film-coated, round, biconvex, beveled edge, unscored tablets debossed with M on one side of the tablet and C37 on the other side.

NDC 51079-597-20 - Unit dose buler packages of 100 (10 cards of 10 tablets each).

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Made in India

Code No.: MH/DRUGS/25/NKD/89

Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A.

S-12769 10/21

Package Label.principal Display Panel


PRINCIPAL DISPLAY PANEL - 10 mg

NDC 51079-597-20

Cetirizine HCl Tablets, USP 10 mg

Antihistamine

Indoor & Outdoor Allergies

24 Hour Relief (See Uses section of enclosed leaflet)

TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Made in India

S-12721
  • This unit dose package is not child resistant.
  • For institutional use only.
  • Keep this and all drugs out of the reach of children.
  • This container provides light-resistance.
  • See window for lot number and expiration date.

Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A.

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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