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NDC 11523-7162-03 Claritin-D 5; 120 mg/1; mg/1 Details
Claritin-D 5; 120 mg/1; mg/1
Claritin-D is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Bayer HealthCare LLC.. The primary component is LORATADINE; PSEUDOEPHEDRINE SULFATE.
MedlinePlus Drug Summary
Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include sneezing, runny nose, and itchy eyes, nose, or throat. Loratadine is also used to treat itching and redness caused by hives. However, loratadine does not prevent hives or other allergic skin reactions. Loratadine 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. Loratadine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of loratadine alone. If you are taking the loratadine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.
Related Packages: 11523-7162-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine
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: 11523-7162-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 11523-7162 |
|---|---|
| Product ID | 11523-7162_0b61c541-d061-9abf-e063-6294a90a7574 |
| Associated GPIs | 43993002597430 |
| GCN Sequence Number | 017181 |
| GCN Sequence Number Description | loratadine/pseudoephedrine TAB ER 12H 5 MG-120MG ORAL |
| HIC3 | Z2O |
| HIC3 Description | 2ND GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION |
| GCN | 63570 |
| HICL Sequence Number | 006605 |
| HICL Sequence Number Description | LORATADINE/PSEUDOEPHEDRINE SULFATE |
| Brand/Generic | Brand |
| Proprietary Name | Claritin-D |
| Proprietary Name Suffix | 12 Hour |
| Non-Proprietary Name | Loratadine and pseudoephedrine sulfate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 5; 120 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | LORATADINE; PSEUDOEPHEDRINE SULFATE |
| Labeler Name | Bayer HealthCare LLC. |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA019670 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 11523-7162-03 (11523716203)
| NDC Package Code | 11523-7162-3 |
|---|---|
| Billing NDC | 11523716203 |
| Package | 3 BLISTER PACK in 1 CARTON (11523-7162-3) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2009-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |