309 - Health A2z Allergy Relief

SPL v10

SPL

SPL Set ID f0db3a13-43e6-4243-9a3a-7808ddd005e1

Route

ORAL

Published

Effective Date 2020-06-16

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: H;L20 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

ANDA Active Since 2025-03-18

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:

runny nose
itchy, watery eyes
sneezing
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

Other Information

store between 20° to 25°C (68° to 77°F)
protect from excessive moisture
do not use if imprinted seal under safety cap is broken or missing

Inactive Ingredients

*corn starch, lactose monohydrate, magnesium stearate ,

pregelantinized starch, *sodium starch glycolate

*May contain these ingredients

Pregnancy/breastfeeding

ask a health professional before use.

Principal Display Panel

Loratadine 10mg

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

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Loratadine 10mg

Ask A Doctor Before Use If You Have

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

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

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

Other Information (Other information)

store between 20° to 25°C (68° to 77°F)
protect from excessive moisture
do not use if imprinted seal under safety cap is broken or missing

Inactive Ingredients (Inactive ingredients)

*corn starch, lactose monohydrate, magnesium stearate ,

pregelantinized starch, *sodium starch glycolate

*May contain these ingredients

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a health professional before use.

Principal Display Panel

Loratadine 10mg

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)

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

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

Loratadine 10mg

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.

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": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "CNTM", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "classCode": "CNTM", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "CNTM", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "classCode": "CNTM", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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 ", "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", "Other information": "store between 20° to 25°C (68° to 77°F) protect from excessive moisture do not use if imprinted seal under safety cap is broken or missing", "Inactive ingredients": "*corn starch, lactose monohydrate, magnesium stearate , pregelantinized starch, *sodium starch glycolate *May contain these ingredients", "Pregnancy/Breastfeeding": "ask a health professional before use.", "Principal Display Panel": "Loratadine 10mg Loratadine 10mg", "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": "In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.", "Active ingredient (in each tablet)": "Loratadine 10mg", "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: 2026-02-15T12:07:08.532523 · Updated: 2026-03-14T23:13:35.542610