CRCLE FEXOFENADINE HYDROCHLORIDE- fexofenadine hydrochloride tablet

Crcle Fexofenadine Hydrochloride by

Drug Labeling and Warnings

Crcle Fexofenadine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Innovus Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient 

Fexofenadine HCl USP 60 mg (for 60 mg)

Fexofenadine HCl USP 180 mg (for 180 mg)

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

• runny nose 
• sneezing 
• itchy, watery eyes
•  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 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours (for 60 mg)

  take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours (for 180 mg)

• 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

• Safety-sealed: do not use if imprinted foil under bottle cap is opened or torn.
• store between 20º and 25ºC (68º and 77ºF)
• 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?

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

PRINCIPAL DISPLAY PANEL

C'rcle Allergy Relief

Fexofenadine HCl Tablets, USP 60 mg

Antihistamine

100 Tablets

NDC: 57483-240-02

C'rcle Allergy Relief

Fexofenadine HCl Tablets, USP 180 mg

Antihistamine

150 Tablets

INGREDIENTS AND APPEARANCE

CRCLE FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57483-230
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	60 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (Peach)	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	G5
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57483-230-01	100 in 1 CONTAINER; Type 0: Not a Combination Product	04/28/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211075	12/18/2020

CRCLE FEXOFENADINE HYDROCHLORIDE 
fexofenadine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57483-240
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2910 (15 MPA.S) (UNII: 36SFW2JZ0W)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	orange (peach)	Score	no score
Shape	OVAL (capsule shaped)	Size	17mm
Flavor		Imprint Code	G6
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57483-240-02	150 in 1 CONTAINER; Type 0: Not a Combination Product	04/10/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211075	12/18/2020

Labeler - Innovus Pharmaceuticals, Inc. (962507187)