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
Purpose

Antihistamine

Description

Drug Facts

Medication Information

Active Ingredient

Loratadine, USP 10 mg

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
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

corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Description

Drug Facts

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.

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

Active Ingredient (Active ingredient (in each tablet))

Loratadine, USP 10 mg

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
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

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.

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

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