Loratadine 10mg Tablets

SPL v2

SPL

SPL Set ID db71197e-d633-644d-e053-2a95a90a261d

Route

ORAL

Published

Effective Date 2022-03-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

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

Marketing Status

ANDA Active Since 2022-03-30

Description

Loratadine 10mg

Medication Information

Dosage and Administration

Adults and children 6 years and over 1 tablet 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

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

Section 50566-9

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

Section 50567-7

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

Section 50569-3

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

Section 50570-1

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

Section 50741-8

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

Section 51727-6

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

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Antihistamine

Section 55106-9

Loratadine 10mg

Structured Label Content

Dosage and Administration (34068-7)

Adults and children 6 years and over 1 tablet 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)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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

Section 50741-8 (50741-8)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Antihistamine

Section 55106-9 (55106-9)

Loratadine 10mg

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": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "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)

{"34068-7": "Adults and children 6 years and over 1 tablet 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", "50565-1": "Keep out of reach of children. In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50567-7": "When using this product do not take more than directed. Taking more than directed may cause drowsiness.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients", "50741-8": "Other Information ● store between 20-25°C (68-77°F) ● protect from excessive moisture ● do not use if imprinted seal under safety cap is broken or missing", "51727-6": "Inactive Ingredients lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Antihistamine", "55106-9": "Loratadine 10mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:17.138815 · Updated: 2026-03-14T23:06:51.816479