CURIST ALLERGY RELIEF- levocetirizine dihydrochloride tablet

Curist Allergy Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Read directions and warnings before use. Keep carton as it contains important information.

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Levocetirizine dihydrochloride USP 5 mg

PURPOSE

Purpose

Antihistamine

INDICATIONS & USAGE

Uses

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

• runny nose
• sneezing
• itchy, watery eyes
• itching of the nose or throat

WARNINGS

Warnings

Do not use

• if you have kidney disease
• if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

Ask a doctor before use if you have ever had trouble urinating or emptying your bladder.

When using this product

• drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• you have trouble urinating or emptying your bladder
• an allergic reaction to this product occurs. Seek medical help right away.

If pregnant or breast-feeding,

• if breast-feeding: not recommended
• if pregnant: 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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

Directions

• adults 65 years and older:

  ask a doctor

• adults and children 12-64 years:
  • take 1 tablet (5 mg) once daily in the evening
  • do not take more than 1 tablet (5 mg) in 24 hours
  • ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms
• children 6-11 years:
  • take ½ tablet (2.5 mg) once daily in the evening
  • do not take more than ½ tablet (2.5 mg) in 24 hours
• children under 6 years: do not use
• consumers with kidney disease: do not use

STORAGE AND HANDLING

Other information

• ​store between 20° and 25°C (68° and 77°F)
• safety sealed: do not use if carton was opened or torn

INACTIVE INGREDIENT

Inactive ingredients hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, silicon dioxide, titanium dioxide

QUESTIONS

Questions? call 1-855-243-1241

SPL UNCLASSIFIED SECTION

Distributed by:

Little Pharma, Inc. New York, NY 10023

Made in India

PRINCIPAL DISPLAY PANEL

curist

Allergy Relief

Levocetirizine Dihydrochloride Tablets, USP 5 mg

Antihistamine

24 Hour Relief of Runny Nose; Sneezing; Itchy, Watery Eyes; Itchy Nose or Throat

90 Tablets

INGREDIENTS AND APPEARANCE

CURIST ALLERGY RELIEF 
levocetirizine dihydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72559-007
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O)	LEVOCETIRIZINE DIHYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	8mm
Flavor		Imprint Code	LI
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72559-007-05	1 in 1 CARTON	10/15/2019
1		90 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211551	10/15/2019

Labeler - Little Pharma, Inc. (074328189)