Fexofenadine HCL by Meijer, Inc. FEXOFENADINE HCL tablet

Fexofenadine HCL by

Drug Labeling and Warnings

Fexofenadine HCL by is a Otc medication manufactured, distributed, or labeled by Meijer, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each tablet)

Fexofenadine HCl USP, 180mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
 runny nose  itchy, watery eyes  sneezing  itching of the nose or throat

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

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)

Stop use and ask a doctor if

an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

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 ask a doctor
and older

consumers with kidney ask a doctor
disease

Other information

 safety sealed: do not use if imprinted foil under bottle cap is opened or torn
 store between 20° and 25°C (68° and 77°F)
 protect from excessive moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, pregelatinized starch, titanium dioxide

Questions or comments?

contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Principal Display Panel

INGREDIENTS AND APPEARANCE

FEXOFENADINE HCL 
fexofenadine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79481-6230
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
D&C RED NO. 28 (UNII: 767IP0Y5NH)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
GELATIN (UNII: 2G86QN327L)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)

Product Characteristics
Color	gray (White band in the middle)	Score	no score
Shape	OVAL (capsule shaped tablet)	Size	20mm
Flavor		Imprint Code	G18
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79481-6230-6	60 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2024
2	NDC: 79481-6230-2	24 in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211075	07/01/2024

Labeler - Meijer, Inc. (006959555)