drug facts

drug facts

SPL v3

SPL

SPL Set ID ff1b0b4e-f74f-451d-8d13-4fa707727547

Route

oral

Published

Effective Date 2012-06-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

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 2003-08-28

Purpose

Antihistamine

Description

Loratadine USP, 10 mg

Medication Information

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 and kidney disease	ask a doctor

Inactive Ingredients

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Description

Loratadine USP, 10 mg

Questions?

Call 1-800-406-7984

Use(s)

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

Do Not Use

If you have ever had an allergic reaction to this product or any of its ingredients.

Active Ingredient(s)

Loratadine USP, 10 mg

When Using This Product

Do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask A Doctor If

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

If Pregnant Or Breast Feeding,

Ask a health professional before use.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

Liver or kidney disease. Your doctor should determine if you need a different dose.

Loratadine Allergy Relief (loratadine) Tablet

Structured Label Content

Purpose (PURPOSE)

Antihistamine

Directions (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 and kidney disease	ask a doctor

Inactive Ingredients (INACTIVE INGREDIENTS)

Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch

Questions? (QUESTIONS?)

Call 1-800-406-7984

Use(s) (USE(S))

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

Do Not Use (Do not use)

If you have ever had an allergic reaction to this product or any of its ingredients.

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Loratadine USP, 10 mg

When Using This Product (When using this product)

Do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

Ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

Liver or kidney disease. Your doctor should determine if you need a different dose.

Loratadine Allergy Relief (loratadine) Tablet (LORATADINE ALLERGY RELIEF (LORATADINE) TABLET)

Advanced Ingredient Data

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

Raw Label Data

All Sections (JSON)

{"USE(S)": "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 and kidney disease ask a doctor", "Do not use": "If you have ever had an allergic reaction to this product or any of its ingredients.", "QUESTIONS?": "Call 1-800-406-7984", "ACTIVE INGREDIENT(S)": "Loratadine USP, 10 mg", "INACTIVE INGREDIENTS": "Corn starch, lactose monohydrate, magnesium stearate, pregelatinized starch", "When using this product": "Do not take more than directed. Taking more than directed may cause drowsiness.", "Stop use and ask a doctor if": "An allergic reaction to this product occurs. Seek medical help right away.", "If pregnant or breast-feeding,": "Ask a health professional before use.", "Keep out of reach of children.": "In case of overdose, get medical help or contact a Poison Control Center right away.", "Ask a doctor before use if you have": "Liver or kidney disease. Your doctor should determine if you need a different dose."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:13.524445 · Updated: 2026-03-14T22:54:33.877898