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NDC 62011-0455-01 Allergy and Congestion 60; 120 mg/1; mg/1 Details
Allergy and Congestion 60; 120 mg/1; mg/1
Allergy and Congestion is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services, LLC. The primary component is FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
The combination of fexofenadine and pseudoephedrine is used in adults and children 12 years of age and older to relieve the allergy symptoms of seasonal allergic rhinitis ('hay fever'), including runny nose; sneezing; congestion (stuffy nose); red, itchy, or watery eyes; or itching of the nose, throat, or roof of the mouth. Fexofenadine is in a class of medications called antihistamines. It works by blocking the effects of histamine, a substance in the body that causes allergy symptoms. Pseudoephedrine is in a class of medications called decongestants. It works by drying up the nasal passages.
Related Packages: 62011-0455-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Fexofenadine and Pseudoephedrine
Product Information
| NDC | 62011-0455 |
|---|---|
| Product ID | 62011-0455_a651e527-95f4-2565-3ea0-dd5173944cd8 |
| Associated GPIs | |
| GCN Sequence Number | 036868 |
| GCN Sequence Number Description | fexofenadine/pseudoephedrine TAB ER 12H 60MG-120MG ORAL |
| HIC3 | Z2O |
| HIC3 Description | 2ND GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION |
| GCN | 63565 |
| HICL Sequence Number | 016846 |
| HICL Sequence Number Description | FEXOFENADINE HCL/PSEUDOEPHEDRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Allergy and Congestion |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Fexofenadine HCl and Pseudoephedrine HCI |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 60; 120 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
| Labeler Name | Strategic Sourcing Services, LLC |
| 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 | ANDA |
| Application Number | ANDA076667 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 62011-0455-01 (62011045501)
| NDC Package Code | 62011-0455-1 |
|---|---|
| Billing NDC | 62011045501 |
| Package | 4 BLISTER PACK in 1 CARTON (62011-0455-1) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2020-07-27 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.47685 |
| Pricing Unit | EA |
| Effective Date | 2023-08-23 |
| NDC Description | HM ALLERGY-CONGEST ER 60-120 MG |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |