Nuvicare-allergy Relief Loratadine Tablets, 10 Mg

Nuvicare-allergy Relief Loratadine Tablets, 10 Mg
SPL v1
SPL
SPL Set ID 023a46f0-8d1c-4f62-953d-3e6458a54f6e
Route
ORAL
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Lactose Monohydrate Magnesium Stearate Povidone Starch, Corn

Identifiers & Packaging

Marketing Status
ANDA Active Since 2025-07-01

Description

Active Ingredient (in each tablet) Loratadine, 10 mg 


Medication Information

Description

Active Ingredient (in each tablet) Loratadine, 10 mg 

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
Section 50565-1

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)

Section 50566-9

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

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

Section 50569-3

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

Section 51945-4

Section 53413-1

Questions or comments?

Call 1(718) 337-8733 or email: [email protected]

Section 53414-9

If pregnanct or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active Ingredient (in each tablet)

Loratadine, 10 mg 

Warnings

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

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 or kidney disease: Ask a doctor

Drug Facts

Other Information
  • Store between 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature)
  •  Protect from excessive moisture
Inactive Ingredients

Lactose monohydrate, magnesium stearate, povidone, maize starch, purified water.


Structured Label Content

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
Section 50565-1 (50565-1)

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)

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments?

Call 1(718) 337-8733 or email: [email protected]

Section 53414-9 (53414-9)

If pregnanct or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active Ingredient (in each tablet)

Loratadine, 10 mg 

Warnings

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

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 or kidney disease: Ask a doctor

Drug Facts

Other Information
  • Store between 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature)
  •  Protect from excessive moisture
Inactive Ingredients (Inactive ingredients)

Lactose monohydrate, magnesium stearate, povidone, maize starch, purified water.


Advanced Ingredient Data


Raw Label Data

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