careone acid relief
Retail Business Services, LLC. Acid Relief Drug Facts
Approved
Approval ID
2f74462a-96ec-bc81-e063-6294a90abfad
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Sep 18, 2025
Manufacturers
FDA
Sixarp, LLC
DUNS: 016329513
FDA
Praxis, LLC
DUNS: 016329513
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
famotidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59368-284
Application NumberANDA077351
Product Classification
M
Marketing Category
C73584
G
Generic Name
famotidine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2025
FDA Product Classification
INGREDIENTS (11)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FAMOTIDINEActive
Quantity: 20 mg in 1 1
Code: 5QZO15J2Z8
Classification: ACTIB
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: 6/7/2022
Package/Label Principal Display Panel
CAREone ™
Compare to the active ingredient in Maximum Strength Zantac 360° ™
MAXIMUM STRENGTH
ACID RELIEF
Famotidine Tablets, 20mg
Acid Reducer
Just one tablet prevents & relieves heartburn due to acid indigestion
Gluten Free
Actual Size
OUR PHARMACISTS RECOMMEND
25 TABLETS
