Allergy Relief
CVS Pharmacy, Inc. Allergy Relief Drug Facts
Approved
Approval ID
7cac266a-4de8-4af1-8324-b01823a3989a
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 16, 2025
Manufacturers
FDA
CVS Pharmacy
DUNS: 062312574
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fexofenadine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69842-914
Application NumberANDA212971
Product Classification
M
Marketing Category
C73584
G
Generic Name
fexofenadine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 16, 2025
FDA Product Classification
INGREDIENTS (13)
FEXOFENADINE HYDROCHLORIDEActive
Quantity: 180 mg in 1 1
Code: 2S068B75ZU
Classification: ACTIB
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C RED NO. 40 ALUMINUM LAKEInactive
Code: 6T47AS764T
Classification: IACT
FD&C YELLOW NO. 6 ALUMINUM LAKEInactive
Code: GYP6Z2JR6Q
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/2/2025
Package/Label Principal Display Panel
CVS Health®
Compare to the active ingredient in Allegra® Allergy
Non-Drowsy
Allergy Relief
FEXOFENADINE HYDROCHLORIDE TABLETS, 180 mg
Antihistamine
INDOOR/OUTDOOR ALLERGY RELIEF
24 HOUR
● Sneezing
● Runny nose
● Itchy, watery eyes
● Itchy nose or throat
Actual Bottle Size on Side Panel
45 TABLETS
Actual Size
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 5/15/2025
Other information
•
do not use if printed foil under cap is broken or missing
•
store between 20° -25°C (68° -77°F)
•
protect from excessive moisture
•
this product meets the requirements of USP Dissolution Test 2
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 5/15/2025
Questions or comments?
1-800-719-9260