Label: FEXOFENADINE HCL tablet
- NDC Code(s): 68788-7449-1, 68788-7449-3, 68788-7449-6, 68788-7449-9
- Packager: Preferred Pharmaceuticals, Inc.
- This is a repackaged label.
- Source NDC Code(s): 69230-300
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 24, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S), in each tablet
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
60 mg
adults and children 12 years of age and over
take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of age
do not use
adults 65 years of age and older
ask a doctor
consumers with kidney disease
ask a doctor
180 mg
adults and children 12 years of age and over
take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of age
do not use
adults 65 years of age and older
ask a doctor
consumers with kidney disease
ask a doctor
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
FEXOFENADINE HCL
fexofenadine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7449(NDC:69230-300) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V) FEXOFENADINE HYDROCHLORIDE 180 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6) LIGHT MINERAL OIL (UNII: N6K5787QVP) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STARCH, CORN (UNII: O8232NY3SJ) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE) Product Characteristics Color PINK Score no score Shape CAPSULE Size 18mm Flavor Imprint Code J;44 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-7449-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2019 2 NDC:68788-7449-6 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2019 3 NDC:68788-7449-9 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2019 4 NDC:68788-7449-1 100 in 1 BOTTLE; Type 0: Not a Combination Product 12/27/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204097 08/19/2016 Labeler - Preferred Pharmaceuticals, Inc. (791119022) Registrant - Preferred Pharmaceuticals, Inc. (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals, Inc. 791119022 REPACK(68788-7449)