Loratadine

Loratadine
SPL v3
SPL
SPL Set ID af62d327-791f-48c1-9200-d49b71558885
Route
ORAL
Published
Effective Date 2019-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: RX526 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2003-08-19
Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

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
Section 42229-5

Drug Facts

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 50570-1

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

Section 53414-9

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

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
Other Information
  • store between 68° to 77° F (20° to 25° C)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Active Ingredient (in Each Tablet)

Loratadine, USP 10 mg

Principal Display Panel 10 Mg Tablet Blister Pack Carton

NDC 56062-526-69

INDOOR & OUTDOOR ALLERGIES

24-HOUR

allergyrelief

LORATADINE TABLETS, USP 10 mg

ANTIHISTAMINE

Non-drowsy*

Relief of:

• Sneezing • Runny nose

• Itchy, watery eyes

• Itchy throat or nose

10 TABLETS

*When taken as directed. See Drug Facts Panel.

ACTUAL SIZE

†Compare to the active

ingredient of Claritin®

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

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 50570-1 (50570-1)

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

Section 53414-9 (53414-9)

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

Purpose

Antihistamine

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
Other Information
  • store between 68° to 77° F (20° to 25° C)
  • protect from excessive moisture
  • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.
Inactive Ingredients (Inactive ingredients)

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Loratadine, USP 10 mg

Principal Display Panel 10 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton)

NDC 56062-526-69

INDOOR & OUTDOOR ALLERGIES

24-HOUR

allergyrelief

LORATADINE TABLETS, USP 10 mg

ANTIHISTAMINE

Non-drowsy*

Relief of:

• Sneezing • Runny nose

• Itchy, watery eyes

• Itchy throat or nose

10 TABLETS

*When taken as directed. See Drug Facts Panel.

ACTUAL SIZE

†Compare to the active

ingredient of Claritin®

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:52.267173 · Updated: 2026-03-14T22:55:38.573608