CURIST ALLERGY RELIEF- fexofenadine hydrochloride 180 mg tablet

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredient (in each film-coated tablet)

Fexofenadine HCl USP 180 mg
PURPOSE

Purpose

Antihistamine
INDICATIONS & USAGE
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
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.

DOSAGE & ADMINISTRATION

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 and older	ask a doctor
consumers with kidney disease	ask a doctor

STORAGE AND HANDLING
Other information
- each tablet contains: sodium 8.2 mg
- store between 20º and 25ºC (68º and 77ºF)
- protect from excessive moisture
- this product meets the requirements of USP Dissolution Test 2
- Tamper Evident: Do not use if imprinted inner safety seal is torn or missing.
INACTIVE INGREDIENT

Inactive ingredients

anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, lactose monohydrate, opadry pink 03B84893 containing hypromellose, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, yellow iron oxide.
QUESTIONS

Questions or comments?

Call 1-844-243-1241 or email hi@curistrelief.com
SPL UNCLASSIFIED SECTION

Rev: 027-22-01

Distributed by:

Little Pharma, Inc.

New York, NY 10023

Made in USA with

Globally Sourced Ingredients

curistrelief.com
PRINCIPAL DISPLAY PANEL

curist

Allergy Relief

Fexofenadine Hydrochloride

Tablets, USP 180 mg

Antihistamine

24 Hour Reilef of Runny Nose; Sneezing;

Itchy, Watery Eyes; Itchy Nose or Throat

Indoor and Outdoor Allergies

Non-Drowsy

200 Tablets

INGREDIENTS AND APPEARANCE

CURIST ALLERGY RELIEF
fexofenadine hydrochloride 180 mg tablet

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FEXOFENADINE HYDROCHLORIDE (UNII: 2S068B75ZU) (FEXOFENADINE - UNII:E6582LOH6V)	FEXOFENADINE HYDROCHLORIDE	180 mg

Ingredient Name	Strength
Inactive Ingredients
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 72559-027-22	200 in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2023
2	NDC: 72559-027-23	300 in 1 BOTTLE; Type 0: Not a Combination Product	01/31/2024
3	NDC: 72559-027-46	30 in 1 BOTTLE; Type 0: Not a Combination Product	02/22/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA204507	03/30/2023

Labeler - Little Pharma, Inc. (074328189)

Curist Allergy Relief by