309 - Xl-3 Allergy

SPL v4

SPL

SPL Set ID afdb0117-dd2d-4ab1-a2f4-2a88b6bf5251

Route

ORAL

Published

Effective Date 2016-12-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Silicon Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: LOR;10;APO Shape: oval Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2014-12-16

Description

Loratadine 10mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Loratadine 10mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

■ sneezing

■ runny nose

■ itchy, watery eyes

■ itching of the nose or throat.

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

Do Not Use

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

Active Ingredient

Loratadine 10mg

Other Information

■ store between 20° to 25°C (68° to 77° F)

■ protect from excessive moisture

■ do not use if blister packaging is torn or open

Inactive Ingredients

croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions Or Comments?

1-888-952-0050 Monday through Friday 9 AM - 5 PM EST

Ask A Doctor Before Use

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

Pregnancy/breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

Principal Display Panel

XL-3 Allergy Relief

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.

Keep Out of Reach of Children

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

■ sneezing

■ runny nose

■ itchy, watery eyes

■ 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

Do Not Use (Do not use)

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

Active Ingredient (Active ingredient)

Loratadine 10mg

Other Information (Other information)

■ store between 20° to 25°C (68° to 77° F)

■ protect from excessive moisture

■ do not use if blister packaging is torn or open

Inactive Ingredients (Inactive ingredients)

croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide

Questions Or Comments? (Questions or comments?)

1-888-952-0050 Monday through Friday 9 AM - 5 PM EST

Ask A Doctor Before Use (Ask a doctor before use)

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

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

If pregnant or breast-feeding, ask a health professional before use.

Principal Display Panel

XL-3 Allergy Relief

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 (Stop use and ask a doctor)

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

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

Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately.

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "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": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ■ sneezing ■ runny nose ■ itchy, watery eyes ■ 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", "Do not use": " if you have ever had an allergic reaction to this product or any of its ingredients", "Active ingredient": "Loratadine 10mg", "Other information": "■ store between 20° to 25°C (68° to 77° F) ■ protect from excessive moisture ■ do not use if blister packaging is torn or open", "Inactive ingredients": "croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, silicon dioxide", "Questions or comments?": "1-888-952-0050 Monday through Friday 9 AM - 5 PM EST", "Ask a doctor before use": "liver or kidney disease. Your doctor should determine if you need a different dose.", "Pregnancy/Breastfeeding": " If pregnant or breast-feeding, ask a health professional before use. ", "Principal Display Panel": "XL-3 Allergy Relief ", "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. ", "Keep out of reach of children": "Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) immediately."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:56.042975 · Updated: 2026-03-14T22:57:15.604123