Loratadine Orally Disintegrating Tablets Usp

SPL v5

SPL

SPL Set ID c20b91e0-ef92-6f2f-e053-2a95a90a2a36

Route

ORAL

Published

Effective Date 2020-06-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (5 mg)

Inactive Ingredients

Anhydrous Citric Acid Pullulan Polysorbate 80 Mannitol

Identifiers & Packaging

Pill Appearance

Imprint: T5 Shape: round Color: white Size: 12 mm Score: 1

Marketing Status

ANDA Active Since 2021-05-19

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.

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.

Warnings

Directions

place 1 tablet on tongue; tablet disintegrates, with or without water

adults and children 6 years and over	1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other Information

safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally disintegrating Tablet, USP is open or torn
store between 20° to 25°C (68° to 77°F)
use tablet immediately after opening individual blister
complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration

Inactive Ingredients

anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan

Questions Or Comments?

1-877-244-9825 - Our Medical Information center shall operate between 9:00 AM to 5:00 PM EST from Monday through Friday (business hours). Queries received outside business hours shall reach voice mail and shall be attended on next business day.

Active Ingredient (in Each Tablet)

Loratadine 5 mg

Package Label.principal Display Panel

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.

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

Warnings

Directions

place 1 tablet on tongue; tablet disintegrates, with or without water

adults and children 6 years and over	1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 6 years of age	ask a doctor
consumers with liver or kidney disease	ask a doctor

Other Information (Other information)

safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally disintegrating Tablet, USP is open or torn
store between 20° to 25°C (68° to 77°F)
use tablet immediately after opening individual blister
complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan

Questions Or Comments? (Questions or comments?)

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

Loratadine 5 mg

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PULLULAN", "unii": "8ZQ0AYU1TT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children . In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50567-7": "When using this product do not take more than directed. Taking more than directed may cause drowsiness.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "53414-9": "If pregnant or breast-feeding , ask a health professional before use.", "Purpose": "Antihistamine", "Directions": "place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor", "Other information": "safety sealed: do not use if the individual blister unit imprinted with Loratadine Orally disintegrating Tablet, USP is open or torn store between 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration", "Inactive ingredients": "anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan", "Questions or comments?": "1-877-244-9825 - Our Medical Information center shall operate between 9:00 AM to 5:00 PM EST from Monday through Friday (business hours). Queries received outside business hours shall reach voice mail and shall be attended on next business day.", "Active ingredient (in each tablet)": "Loratadine 5 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:38.105340 · Updated: 2026-03-14T23:02:18.218337