Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID 4d15d926-9564-4bef-b8a9-768af7a0ab6a

Route

ORAL

Published

Effective Date 2023-12-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2023-12-07

Description

Loratadine 10mg

Medication Information

Warnings and Precautions

Do not useif you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before useif you have liver or kidney disease. Your doctor should determine if you need a different dose.

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctorif an allergic reaction to this product occurs. Seek medical help right away.

Indications and Usage

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

Dosage and Administration

Adult and children over 6 years old:1 tablets daily: no 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

Description

Loratadine 10mg

Section 50565-1

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

Section 51727-6

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

Section 51945-4

Section 55105-1

Antihistamine

Section 55106-9

Loratadine 10mg

Section 60561-8

Store between 20-25 degrees celcius (68-77 degrees farhenheit).

Protect from excessive moisture

Do not use if imprinted seal under bottle cap is broken or missing

You may report side effects 1-888-952-0050

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Adult and children over 6 years old:1 tablets daily: no 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

Warnings and Precautions (34071-1)

Do not useif you have ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before useif you have liver or kidney disease. Your doctor should determine if you need a different dose.

When using this productdo not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctorif an allergic reaction to this product occurs. Seek medical help right away.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Loratadine 10mg

Section 60561-8 (60561-8)

Store between 20-25 degrees celcius (68-77 degrees farhenheit).

Protect from excessive moisture

Do not use if imprinted seal under bottle cap is broken or missing

You may report side effects 1-888-952-0050

Advanced Ingredient Data

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

Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "Adult and children over 6 years old: 1 tablets daily: no 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", "34071-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. 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.", "50565-1": "In case of accidental overdose, contact a doctor or Poison Control Center right away (1-800-222-1222)", "51727-6": "lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate. ", "55105-1": "Antihistamine", "55106-9": "Loratadine 10mg", "60561-8": "Store between 20-25 degrees celcius (68-77 degrees farhenheit). Protect from excessive moisture Do not use if imprinted seal under bottle cap is broken or missing You may report side effects 1-888-952-0050"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:24.212502 · Updated: 2026-03-14T23:10:48.259693