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| Product NDC Code | 71205-093 | ||||||||||
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| Drug Name | Cetirizine hydrochloride |
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| Type | Generic | ||||||||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||||||
| Dosage Form | TABLET | ||||||||||
| RxCUI drug identifier | 1014676 | ||||||||||
| Application Number | ANDA077829 | ||||||||||
| Labeler Name | Proficient Rx LP | ||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS (IN EACH TABLET) Cetirizine HCl USP 5 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS Adults and children 6years 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 over 1 tablet once a day; do not take more than 1 tablet in 24 hours Children under 6 years of age Ask a doctor Consumers with liver or kidney disease Ask a doctor
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS hypromellose, lactose, magnesium stearate, maize starch, polyethylene glycol, povidone, titanium dioxide.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.PURPOSE Antihistimine
Spl product data elements
Usually a list of ingredients in a drug product.Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine Hydrochloride Cetirizine HYPROMELLOSE, UNSPECIFIED LACTOSE, UNSPECIFIED FORM magnesium stearate starch, corn POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED titanium dioxide White Barrel Shaped CTN;5
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Cetirizine Hydrochloride Tablets USP 5 mg NDC 71205-093-30 Original Prescription Strength Cetirizine Hydrochloride Tablets 5 mg 30 Tablets 71205-093-30
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.OTHER INFORMATION Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Manufactured by: Unique Pharmaceutical Labs, (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 M. L. G/1430 May 2018 120004 Repackaged By; Proficient Rx LP Thousand Oaks 91320
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN In case of overdose, get medical help or contact Poison Control Center right away. (1-800-222-1222)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS Call 1-866-562-4597
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS: 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. ASK DOCTOR Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. 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. 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)
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API