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NDC 49483-0682-01 Cetirizine Hydrochloride 5 mg/1 Details
Cetirizine Hydrochloride 5 mg/1
Cetirizine Hydrochloride is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by TIME CAP LABORATORIES, INC.. The primary component is CETIRIZINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Cetirizine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and allergy to other substances (such as dust mites, animal dander, cockroaches, and molds). These symptoms include sneezing; runny nose; itchy, red, watery eyes; and itchy nose or throat. Cetirizine is also used to treat itching and redness caused by hives. However, cetirizine does not prevent hives or other allergic skin reactions. Cetirizine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Cetirizine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of cetirizine alone. If you are taking the cetirizine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.
Related Packages: 49483-0682-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine
Product Information
| NDC | 49483-0682 |
|---|---|
| Product ID | 49483-682_dfbdaf6a-c5e8-c5f9-e053-2995a90ae2c6 |
| Associated GPIs | 41550020100310 |
| GCN Sequence Number | 024484 |
| GCN Sequence Number Description | cetirizine HCl TABLET 5 MG ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 49292 |
| HICL Sequence Number | 006544 |
| HICL Sequence Number Description | CETIRIZINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Cetirizine Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Cetirizine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | CETIRIZINE HYDROCHLORIDE |
| Labeler Name | TIME CAP LABORATORIES, INC. |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078933 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49483-0682-01 (49483068201)
| NDC Package Code | 49483-682-01 |
|---|---|
| Billing NDC | 49483068201 |
| Package | 100 TABLET in 1 BOTTLE (49483-682-01) |
| Marketing Start Date | 2022-05-30 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.04849 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | ALLERGY RLF (CETRZN) 5 MG TAB |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL dfbddafb-9455-5805-e053-2a95a90ad0d9 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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.
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.
SPL UNCLASSIFIED SECTION
Directions
| adults and children 6 years and over | 1 or 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 |
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet |
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| Labeler - TIME CAP LABORATORIES, INC. (037052099) |
| Registrant - TIME CAP LABORATORIES, INC. (037052099) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| MARKSANS PHARMA LIMITED | 925822975 | manufacture(49483-682) | |