Loratadine - DailyMed Details

Loratadine

SPL v3

SPL

SPL Set ID 0a0d700d-bdba-4c90-a947-5d61d40ce4df

Route

ORAL

Published

Effective Date 2025-07-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate Povidone, Unspecified Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: 10;p Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2024-03-26

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

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

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

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)

Container Label

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "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.", "51727-6": "Inactive ingredients corn starch, lactose monohydrate, magnesium stearate, povidone", "53413-1": "Questions or comments? Call 1-800-874-7464 Monday to Friday 9 AM to 5 PM EST", "53414-9": "If pregnanct or breast-feeding , ask a health professional before use.", "55105-1": "Purpose Antihistamine", "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 ", "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": "Container Label"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:36.785838 · Updated: 2026-03-14T23:09:28.158875