CURIST ALLERGY RELIEF- loratadine 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

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each tablet)

Loratadine 10 mg

PURPOSE

Purpose

Antihistamine

INDICATIONS & USAGE

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

Warnings

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

Ask a doctor before you if you have liver or kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

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 (1-800-222-1222).

DOSAGE & ADMINISTRATION

Directions

• adults and children 6 years and over:

  1 tablet daily; not more than 1 tablet in 24 hours

• children under 6 years of age:

  ask a doctor

• consumers with liver and kidney disease:

  ask a doctor

STORAGE AND HANDLING

Other information

• TAMPER EVIDENT: do not use if imprinted seal under cap is missing or broken
• store between 20° and 25°C (68° and 77°F)

INACTIVE INGREDIENT

Inactive ingredients

lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

QUESTIONS

Questions or comments? Call 1-800-540-3765

SPL UNCLASSIFIED SECTION

Distributed by:

Little Pharma, Inc., New York, NY 10023

PRINCIPAL DISPLAY PANEL

curist

Allergy Relief
Loratadine Tablets, 10 mg

Antihistamine

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

30 Tablets

INGREDIENTS AND APPEARANCE

CURIST ALLERGY RELIEF 
loratadine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72559-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN)	LORATADINE	10 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	8mm
Flavor		Imprint Code	L612
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72559-005-02	1 in 1 CARTON	06/11/2019
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 72559-005-04	25 in 1 CARTON	03/27/2019	06/11/2019
2		1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076301	03/27/2019

Labeler - Little Pharma, Inc. (074328189)