Fexofenadine HCl and Pseudoephedrine HCI

Product NDC
59779-508
11-digit product format
597790508
Labeler code
59779
Product ID
59779-508_aac03106-806f-bc8c-056c-bed65497dd54
Type
HUMAN OTC DRUG
Nonproprietary name
Fexofenadine HCl and Pseudoephedrine HCI
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA076667
Marketing category
ANDA
Marketing start
2014-11-19
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076667-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2014-11-18

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCICVS Pharmacy3e295047-1a46-a0d8-2e3f-ec4086f5aedb2015-08-24WarningsExact identifier

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
IngredientStrength
FEXOFENADINE HYDROCHLORIDE60 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2S068B75ZU, 6V9V2RYJ8N
Rxcui997406

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-508-14Fexofenadine HCl and Pseudoephedrine HCI5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE52
59779-508-14Fexofenadine HCl and Pseudoephedrine HCI4 in 1 CARTONTABLET, EXTENDED RELEASE42
59779-508-31Fexofenadine HCl and Pseudoephedrine HCI5 in 1 BLISTER PACKTABLET, EXTENDED RELEASE52
59779-508-31Fexofenadine HCl and Pseudoephedrine HCI6 in 1 CARTONTABLET, EXTENDED RELEASE62

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FEXOFENADINE HYDROCHLORIDEACTIVE INGREDIENT2S068B75ZUFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [CVS PHARMACY]1
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [CVS PHARMACY]1
FEXOFENADINEACTIVE MOIETYE6582LOH6VFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [CVS PHARMACY]1
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [CVS PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [CVS PHARMACY]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [CVS PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [CVS PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [CVS PHARMACY]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [CVS PHARMACY]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [CVS PHARMACY]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [CVS PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [CVS PHARMACY]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-508FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI TABLET, EXTENDED RELEASE [CVS PHARMACY]2Current NDC, Legacy NDC, 4 package rows20171206_3e295047-1a46-a0d8-2e3f-ec4086f5aedb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997406fexofenadine HCl 60 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSN3e295047-1a46-a0d8-2e3f-ec4086f5aedb2
99740612 HR fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCD3e295047-1a46-a0d8-2e3f-ec4086f5aedb2
997406fexofenadine hydrochloride 60 MG / pseudoephedrine hydrochloride 120 MG 12 HR Extended Release Oral TabletSY3e295047-1a46-a0d8-2e3f-ec4086f5aedb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-508-14597790508144 BLISTER PACK in 1 CARTON (59779-508-14) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2014-11-190000-00-00NoNoCurrent
59779-508-31597790508316 BLISTER PACK in 1 CARTON (59779-508-31) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK6 blister pack2014-11-190000-00-00NoNoCurrent