Counteract Allergy Content Of Label

Counteract Allergy Content Of Label
SPL v4
SPL
SPL Set ID 6b5d43ad-a709-4e0b-b91c-36ea0afe7221
Route
ORAL
Published
Effective Date 2011-03-17
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

Pill Appearance
Imprint: L612 Shape: oval Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2023-08-19

Description

Active ingredient (in each tablet) Loratadine 10 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Use 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

Dosage and 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 or kidney disease



ask a doctor

















Description

Active ingredient (in each tablet) Loratadine 10 mg

Section 44425-7

Other information

  • store at 20°-25°C (68°-77°F)
  • protect from excessive moisture

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 50570-1

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

Section 51727-6

Inactive ingredients  lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Section 51945-4

Section 53413-1

Questions or comments? 1-800-282-3000

Section 53414-9

If pregnant or breast-feeding, ask a health processional before use.

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Active ingredient (in each tablet)

Loratadine 10 mg


Structured Label Content

Indications and Usage (34067-9)

Use 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

Dosage and Administration (34068-7)

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

















Warnings and Precautions (34071-1)

Warnings

Section 44425-7 (44425-7)

Other information

  • store at 20°-25°C (68°-77°F)
  • protect from excessive moisture

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.

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 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients  lactose monohydrate, magnesium stearate, povidone, pregelatinized starch

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments? 1-800-282-3000

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health processional before use.

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Loratadine 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)