Home NDC 30142-447 Fexofenadine HCl and Pseudoephedrine HCI
Product NDC 30142-447
11-digit product format 301420447
Labeler code 30142
Product ID 30142-447_87210e6e-8312-9d26-4381-b6836b9ab254
Type HUMAN OTC DRUG
Nonproprietary name Fexofenadine HCl and Pseudoephedrine HCI
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler The Kroger Co.
Application ANDA076667
Marketing category ANDA
Marketing start 2015-04-22
Substance FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength 60; 120 mg/1; mg/1
Pharmacologic classes Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076667-001 FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 60MG;120MG TABLET, EXTENDED RELEASE / ORAL 2014-11-18
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have difficulty swallowing Ask a doctor before use if you have heart disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) the tablet coating may be seen in the stool (this is normal). Continue to takeas directed (see Directions). Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever you get nervous, dizzy, or sleepless Pregnancy/Breastfeeding ask a health professional before use. Keep out of reach of children In case of overdose, get medical help or contacta Poison Control Center right away.
Additional Listing Data#
Finished product Yes
Brand name base Fexofenadine HCl and Pseudoephedrine HCI
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FEXOFENADINE HYDROCHLORIDE 60 mg/1 PSEUDOEPHEDRINE HYDROCHLORIDE 120 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 2S068B75ZU, 6V9V2RYJ8N Rxcui 997406
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 30142-447-14 Fexofenadine HCl and Pseudoephedrine HCI 4 in 1 CARTON TABLET, EXTENDED RELEASE 4 2 30142-447-14 Fexofenadine HCl and Pseudoephedrine HCI 5 in 1 BLISTER PACK TABLET, EXTENDED RELEASE 5 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FEXOFENADINE HYDROCHLORIDE ACTIVE INGREDIENT 2S068B75ZU FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [THE KROGER CO.] 1 PSEUDOEPHEDRINE HYDROCHLORIDE ACTIVE INGREDIENT 6V9V2RYJ8N FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [THE KROGER CO.] 1 FEXOFENADINE ACTIVE MOIETY E6582LOH6V FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [THE KROGER CO.] 1 PSEUDOEPHEDRINE ACTIVE MOIETY 7CUC9DDI9F FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [THE KROGER CO.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [THE KROGER CO.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [THE KROGER CO.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [THE KROGER CO.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [THE KROGER CO.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [THE KROGER CO.] 1 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [THE KROGER CO.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [THE KROGER CO.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [THE KROGER CO.] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [THE KROGER CO.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 30142-447 FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [THE KROGER CO.] 2 Current NDC, Legacy NDC, 2 package rows 20171208_cb9e98a9-74e6-7a3e-9c5e-3bc35c4bbca6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 30142-447-14 30142044714 4 BLISTER PACK in 1 CARTON (30142-447-14) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 4 blister pack 2015-04-22 0000-00-00 No No Current