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| Product NDC Code | 72657-128 | ||||||||||||||||||||||||||||||||||||
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| Drug Name | Cetirizine hcl |
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| Type | Brand | ||||||||||||||||||||||||||||||||||||
| 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, 1014678 |
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| Application Number | ANDA078427 | ||||||||||||||||||||||||||||||||||||
| Labeler Name | GLENMARK THERAPEUTICS INC., USA | ||||||||||||||||||||||||||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Cetirizine HCl 5 mg Cetirizine HCl 10 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.Cetirizine Hydrochloride Tablets, USP 5 mg adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10) once daily depending upon severity of symptoms; do not take more than 2 tablets (10) in 24 hours. adults 65 years and over 1 tablet (5 mg) once a day; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor Cetirizine Hydrochloride Tablets, USP 10 mg 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, 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.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.Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Cetirizine HCl Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE C;13 Cetirizine HCl Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE C;17 Cetirizine HCl Cetirizine Cetirizine HCl Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE C;13 Cetirizine HCl Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE C;13 Cetirizine HCl Cetirizine Cetirizine HCl Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE C;17 Cetirizine HCl Cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A TITANIUM DIOXIDE C;17
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.Principal Display Panel 5mg365label
Principal Display Panel 10mg365label
Principal Display Panel NDC 72657-130-89 5 mg - 150 Tablets (contains one bottle of 60 Tablets and one bottle of 90 Tablets 5mgkit
Principal Display Panel 10mgkit
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 between 20°C to 25°C (68°F to 77°F) • do not use of imprinted foil inner seal on bottle is broken or missing. • FDA approved organic impurities test procedure differs from USP
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 a Poison Control Center right away (1-800-222-1222)
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Questions or comments? call toll-free weekdays 9 AM to 5 PM EST at 1 (888) 721-7115 Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India Distributed by: Glenmark Therapeutics Inc., USA Mahwah, NJ 07430 Product of India February 2024
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.Do not use if you have ever had an allergic reaction to this product or any of its ingredients or an antihistamine containing hydroxyzine Ask a doctor before useif 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 (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