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.

Active Ingredient

Loratadine 10mg

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 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

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.

Active Ingredient (55106-9)

Loratadine 10mg

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

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 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