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| Product NDC Code | 69230-321 | ||||||||||||||
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| Drug Name | Levocetirizine dihydrochloride |
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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, FILM COATED | ||||||||||||||
| RxCUI drug identifier | 855172 | ||||||||||||||
| Application Number | ANDA213513 | ||||||||||||||
| Labeler Name | Camber Consumer Care Inc | ||||||||||||||
| 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 INGREDIENT(S) Levocetirizine dihydrochloride 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 65 years of age and older ask a doctor adults and children 12 to 64 years of age take 1 tablet (5 mg) once daily in the evening do not take more than 1 tablet (5 mg) in 24 hours ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6 to 11 years of age take ½ tablet (2.5 mg) once daily in the evening do not take more than ½ tablet (2.5 mg) in 24 hours children under 6 years of age do not use consumers with kidney disease do not use
| adults 65 years of age and older |
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| adults and children 12 to 64 years of age |
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| children 6 to 11 years of age |
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| children under 6 years of age |
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| consumers with kidney disease |
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, 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.USE(S) temporarily relieves these symptoms due to hay fever or other 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 Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE SILICON DIOXIDE MAGNESIUM STEARATE TITANIUM DIOXIDE HYPROMELLOSE 2910 (3 MPA.S) HYPROMELLOSE 2910 (6 MPA.S) POLYETHYLENE GLYCOL 400 POLYSORBATE 80 White to off white H;LL
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 Levocetirizine Dihydrochloride Tablets USP 5 mg-35's Container carton Compare to XYZAL ® Allergy 24HR Active Ingredient* Allergy Relief Levocetirizine Dihydrochloride Tablets, USP 5 mg Antihistamine 24 HOUR Relief of Sneezing Runny Nose Itchy Nose or Throat Itchy, Watery Eyes Original Prescription Strength 35 TABLETS Levocetirizine Dihydrochloride Tablets USP 5 mg - 35's Container label Compare to XYZAL ® Allergy 24HR Active Ingredient* Allergy Relief Levocetirizine Dihydrochloride Tablets, USP 5 mg Antihistamine 24 HOUR Relief of •Sneezing •Runny Nose •Itchy Nose or Throat •Itchy, Watery Eyes Original Prescription Strength 35 TABLETS carton bottle label
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° and 25°C (68° and 77°F) • safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing • safety sealed: do not use if carton was opened or if individual blister unit is open or torn
QUESTIONS or COMMENTS? call 1-888-588-1418. Distributed by: Camber Consumer Care, Inc. Piscataway, NJ 08854, USA.
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.ASK A DOCTOR BEFORE USE IF YOU HAVE ever had trouble urinating or emptying your bladder
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.DO NOT USE • if you have kidney disease • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine
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).
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.STOP USE AND ASK A DOCTOR IF • you have trouble urinating or emptying your bladder • an allergic reaction to this product occurs. Seek medical help right away.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIF PREGNANT OR BREAST-FEEDING if breast-feeding: not recommended if pregnant: ask a health professional before use
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