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NDC 50580-0728-12 ZYRTEC-D 5; 120 mg/1; mg/1 Details
ZYRTEC-D 5; 120 mg/1; mg/1
ZYRTEC-D is a ORAL TABLET, FILM COATED, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Johnson & Johnson Consumer Inc.. The primary component is CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE 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: 50580-0728-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Cetirizine
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
Related Packages: 50580-0728-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 50580-0728 |
|---|---|
| Product ID | 50580-728_f767ddcc-8ce5-1940-e053-6294a90aedec |
| Associated GPIs | 43993002277420 |
| GCN Sequence Number | 048415 |
| GCN Sequence Number Description | cetirizine HCl/pseudoephedrine TAB ER 12H 5 MG-120MG ORAL |
| HIC3 | Z2O |
| HIC3 Description | 2ND GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION |
| GCN | 13866 |
| HICL Sequence Number | 022864 |
| HICL Sequence Number Description | CETIRIZINE HCL/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | ZYRTEC-D |
| Proprietary Name Suffix | Allergy Plus Congestion |
| Non-Proprietary Name | Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 5; 120 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Johnson & Johnson Consumer Inc. |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021150 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 50580-0728-12 (50580072812)
| NDC Package Code | 50580-728-12 |
|---|---|
| Billing NDC | 50580072812 |
| Package | 2 BLISTER PACK in 1 CARTON (50580-728-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2008-01-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |