Loratadine

Loratadine
SPL v1
SPL
SPL Set ID d28128a3-af54-440e-9bd4-0fccf393d18a
Route
ORAL
Published
Effective Date 2022-03-07
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 2022-03-10

Description

Active Ingredient (in each tablet) Loratadine, 10 mg USP


Medication Information

Description

Active Ingredient (in each tablet) Loratadine, 10 mg USP

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.

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 51727-6

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

Section 53413-1

Questions or comments?

Call 1-800-874-7464 Monday to Friday 9 AM to 5 PM EST

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 USP

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 of age 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
  • Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.
  • Store between 20° - 25°C (68°-77°F)
Package Label.principal Display Panel

30 Count Container Label

100 Count Container Label


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.

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 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions or comments?

Call 1-800-874-7464 Monday to Friday 9 AM to 5 PM EST

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 USP

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 of age 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
  • Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken.
  • Store between 20° - 25°C (68°-77°F)
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

30 Count Container Label

100 Count Container Label


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)