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NDC 51079-0597-20 Cetirizine Hydrochloride 10 mg/1 Details
Cetirizine Hydrochloride 10 mg/1
Cetirizine Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Mylan Institutional 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: 51079-0597-20Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine
Product Information
| NDC | 51079-0597 |
|---|---|
| Product ID | 51079-597_df2722c0-f75d-2bb6-e053-2a95a90ad3e5 |
| Associated GPIs | 41550020100320 |
| GCN Sequence Number | 017037 |
| GCN Sequence Number Description | cetirizine HCl TABLET 10 MG ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 49291 |
| 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, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | CETIRIZINE HYDROCHLORIDE |
| Labeler Name | Mylan Institutional Inc. |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076677 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51079-0597-20 (51079059720)
| NDC Package Code | 51079-597-20 |
|---|---|
| Billing NDC | 51079059720 |
| Package | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-597-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-597-01) |
| Marketing Start Date | 2012-03-30 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.06399 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | CETIRIZINE HCL 10 MG TABLET |
| 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 bd0dc7f6-5fb9-4381-bd81-b150b75a2c68 Details
SPL UNCLASSIFIED SECTION
Uses
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.
Directions (24 Hour Relief)
|
adults and children
|
one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.
|
|
adults 65 years
|
ask a doctor |
|
children under
|
ask a doctor |
|
consumers with liver
|
ask a doctor |
Inactive ingredients
Questions? 1-800-848-0462
HOW SUPPLIED
Cetirizine Hydrochloride Tablets, USP are available as follows:
10 mg - White, film-coated, round, biconvex, beveled
edge, unscored tablets debossed with
M on one side of
the tablet and
C37 on the other side.
NDC 51079-597-20 - Unit dose blister packages
of 100 (10 cards of 10 tablets each).
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Made in India
Code No.: MH/DRUGS/25/NKD/89
Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.
S-12769
10/21
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 10 mg
NDC 51079-597-20
Cetirizine HCl
Tablets, USP
10 mg
Antihistamine
Indoor & Outdoor Allergies
24 Hour Relief
(See Uses section of enclosed leaflet)
TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE
TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.
Made in India
S-12721
- This unit dose package is not child resistant.
- For institutional use only.
- Keep this and all drugs out of the reach of children.
- This container provides light-resistance.
- See window for lot number and expiration date.
Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.
INGREDIENTS AND APPEARANCE
| CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coated |
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| Labeler - Mylan Institutional Inc. (039615992) |