414-allergy Relief

SPL v2

SPL

SPL Set ID 3a580dc7-ff09-462c-9b18-205105349035

Route

ORAL

Published

Effective Date 2020-11-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate Starch, Corn Sodium Starch Glycolate Type A

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2020-11-11

Description

Loratadine 10mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Loratadine 10mg

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

Storage

store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Questions

1-800-327-2704 Monday - Friday 8:00am - 5:00pm (CDT)

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

do not use if blister unit is torn or

Active Ingredient(s)

Loratadine 10mg

Inactive Ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate

Principal Display Panel

Allergy Relief Loratadine

When Using This Product

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

Ask A Doctor Before Use If

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

Stop Use and Ask A Doctor If

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.

Structured Label Content

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

Storage

store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Questions

1-800-327-2704 Monday - Friday 8:00am - 5:00pm (CDT)

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)

do not use if blister unit is torn or

Active Ingredient(s) (Active ingredient(s))

Loratadine 10mg

Inactive Ingredients (Inactive ingredients)

lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate

Principal Display Panel

Allergy Relief Loratadine

When Using This Product (When using this product)

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

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

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

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

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.

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": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "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", "Storage": "store between 20° to 25°C (68° to 77°F) protect from excessive moisture", "Questions": "1-800-327-2704 Monday - Friday 8:00am - 5:00pm (CDT)", "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": "do not use if blister unit is torn or", "Active ingredient(s)": "Loratadine 10mg", "Inactive ingredients": "lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate", "Principal Display Panel": "Allergy Relief Loratadine", "When using this product": "do not take more than directed. Taking more than directed may cause drowsiness.", "Ask a doctor before use if": "or kidney disease. Your doctor should determine if you need a different dose.", "Stop use and ask a doctor if": "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:17.972820 · Updated: 2026-03-14T23:00:39.941399