414-allergy Relief

SPL v4

SPL

SPL Set ID 717ccb47-e13c-4464-b6e6-bea8f24d4663

Route

ORAL

Published

Effective Date 2020-09-28

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Lactose Monohydrate Magnesium Stearate 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 2020-05-01

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

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 open

Active Ingredient(s)

Loratadine 10mg

Inactive Ingredients

lactose monohydrate, magnesium stearate, pregelatinized

starch, sodium starch glycolate

Principal Display Panel

Allergy Relief 30

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.

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center

(1-800-222-1222) right away.

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

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

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 open

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 30

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.

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 accidental overdose, contact a doctor or Poison Control Center

(1-800-222-1222) 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.

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": "SODIUM STARCH GLYCOLATE TYPE A", "unii": "H8AV0SQX4D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "CNTM", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "CNTM", "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", "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 open", "Active ingredient(s)": "Loratadine 10mg", "Inactive ingredients": "lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate", "Principal Display Panel": "Allergy Relief 30 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.", "If pregnant or breast-feeding": "ask a health professional before use.", "Keep out of reach of children": " In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) 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: 2026-02-15T12:00:27.867506 · Updated: 2026-03-14T23:00:54.830446