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Cetirizine hydrochloride (allergy) - Medication Information

Product NDC Code 58602-716
Drug Name

Cetirizine hydrochloride (allergy)

Type Brand
Pharm Class Histamine H1 Receptor Antagonists [MoA],
Histamine-1 Receptor Antagonist [EPC]
Active Ingredients
Cetirizine hydrochloride 10 mg/1
Route ORAL
Dosage Form CAPSULE
RxCUI drug identifier 1014675
Application Number ANDA209107
Labeler Name Aurohealth LLC
Packages
Package NDC Code Description
58602-716-16 1 bottle in 1 carton (58602-716-16) / 65 capsule in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient (in each capsule) Cetirizine HCI USP 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.
Directions adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule 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
adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule 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.
Inactive ingredients gelatin, glycerin, polyethylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution

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 Antihistamine

Spl product data elements

Usually a list of ingredients in a drug product.
Cetirizine Hydrochloride (Allergy) Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 400 WATER SODIUM HYDROXIDE SORBITOL Clear colourless to pale yellow viscous liquid CZ10

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.
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (65's Capsule Container Label) Healthy Living TM Allergy Original Prescription Strength CETIRIZINE HCl Capsules 10 mg Antihistamine Indoor + Outdoor Allergies READ AND KEEP THE OUTER PACKAGE FOR 65 LIQUID GELS * COMPLETE WORNINGS AND INFORMATION *liquid-filled capsules PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (25's Capsule Container Label) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (65's Capsule Container Carton Label) Healthy Living TM Allergy Original Prescription Strength CETIRIZINE HCl Capsules 10 mg Antihistamine Indoor + Outdoor Allergies *Compare to the Active Ingredient in CZ10 Zyrtec® (Actual Size) 24 Hour Relief of: • Sneezing • Runny Nose 65 Liquid Gels* • Itchy, Watery Eyes • Itchy Throat or Nose *liquid-filled capsules figure

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.
Cetirizine HCl Capsules 10 mg (Allergy) Drug Facts

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 liver or kidney disease. Your doctor should determine if you need a different dose.

Ask doctor or pharmacist

Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

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)

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: TS/DRUGS/16/2014

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 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 feeding
If pregnant or breast-feeding: If breast-feeding: not recommended if pregnant: ask a health professional before use.

Storage and handling

Information about safe storage and handling of the drug product.
Other information store at 20°-25°C (68°-77°F) avoid high humidity and excessive heat above 40°C (104°F) protect from light do not use if seal imprinted with SEALED for YOUR PROTECTION under the bottle cap is broken or missing.

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 if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

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