CURIST HIVES RELIEF- fexofenadine hydrochloride 180 mg tablet

Curist Hives Relief by

Drug Labeling and Warnings

Curist Hives Relief by is a Otc medication manufactured, distributed, or labeled by Little Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each film-coated tablet)

Fexofenadine HCl USP 180 mg

PURPOSE

Purpose

Antihistamine

INDICATIONS & USAGE

Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring.

WARNINGS

Warnings

Severe Allergy Warning:

Get emergency help immediately if you have hives along with any of the following symptoms:

• trouble swallowing
• dizziness or loss of consciousness
• swelling of tongue
• swelling in or around mouth
• trouble speaking
• drooling
• wheezing or problems breathing

These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

Not a Substitue for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

Do not use

• to prevent hives from any known cause such as:
• foods
• insect stings
• medicines
• latex or rubber gloves

because this product will not stop hives from occuring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause.

• 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.
• hives that are an unusual color, look bruised or blistered
• hives that do not itch

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.
• symptoms do not improve after 3 days of treatment
• the hives have lasted more than 6 weeks

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

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

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(CONTINUED ON BACK OF LABEL)

Rev: 028-40-01

Distributed by:

Little Pharma, Inc. | New York, NY 10023

Made in USA with Globally Sourced Ingredients

PEEL HERE

PRINCIPAL DISPLAY PANEL

curist

Hives Relief

Fexofenadine Hydrochloride Tablets, USP 180 mg

Antihistamine

24 Hour Relief of Itching due to Hives

Non-Drowsy

60 Tablets

curistrelief.com

Tamper Evident: Do not use if imprinted inner safety seal is torn or missing.

INGREDIENTS AND APPEARANCE

CURIST HIVES RELIEF 
fexofenadine hydrochloride 180 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72559-028
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
FERRIC OXIDE RED (UNII: 1K09F3G675)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
STEARIC ACID (UNII: 4ELV7Z65AP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STARCH, CORN (UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	SG;202
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72559-028-40	60 in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA204507	09/07/2023

Labeler - Little Pharma, Inc. (074328189)