Loratadine Tablets

SPL v2

SPL

SPL Set ID 01cb43cf-57a9-f189-e063-6294a90afd88

Route

ORAL

Published

Effective Date 2023-07-31

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

Pill Appearance

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

Marketing Status

ANDA Active Since 2023-07-31

Description

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

Storage and Handling

Loratidine is supplied as: Bottles of 30 Tablets NDC: 80425-0352-01 store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)

How Supplied

Loratidine is supplied as: Bottles of 30 Tablets NDC: 80425-0352-01 store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)

Medication Information

Storage and Handling

Loratidine is supplied as: Bottles of 30 Tablets NDC: 80425-0352-01 store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)

How Supplied

Loratidine is supplied as: Bottles of 30 Tablets NDC: 80425-0352-01 store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)

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 ifan allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Section 51727-6

Inactive ingredientscorn 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 useif 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)

How Supplied/ Storage and Handling

Loratidine is supplied as:

Bottles of 30 Tablets NDC: 80425-0352-01

store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)

Package Label.principal Display Panel

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 ifan allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3 (50569-3)

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Section 51727-6 (51727-6)

Inactive ingredientscorn 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 useif 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)

How Supplied/ Storage and Handling

Loratidine is supplied as:

Bottles of 30 Tablets NDC: 80425-0352-01

store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)

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

Advanced Ingredient Data

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

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)", "How Supplied/ Storage and Handling": "Loratidine is supplied as: Bottles of 30 Tablets NDC: 80425-0352-01 store at 20-25°C (68-77°F) (see USP Controlled Room Temperature)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:11.104101 · Updated: 2026-03-14T23:06:36.654428