Yyba (as Pld) - Welmate - Loratadine Allergy Relief Tablets, 10 Mg (73581-203)

SPL v7

SPL

SPL Set ID 6103cf98-40b1-4d27-8eb7-6f6a06949730

Route

ORAL

Published

Effective Date 2021-07-28

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: L;39 Shape: round Color: white Size: 7 mm Score: 1

Marketing Status

ANDA Active Since 2021-07-28

Description

Loratadine 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Loratadine 10 mg

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away [1-800-222-1222]

Section 51945-4

Warnings

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.

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

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

Questions?

call toll-free 1-866-933-6337

Other Information

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

Inactive Ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch, glycolate.

Active Ingredient (in Each Tablet)

Loratadine 10 mg

Structured Label Content

Uses

Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

runny nose
sneezing
itchy, watery eyes
itching of the nose or throat

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away [1-800-222-1222]

Section 51945-4 (51945-4)

Purpose

Antihistamine

Warnings

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.

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

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

Questions?

call toll-free 1-866-933-6337

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch, glycolate.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Loratadine 10 mg

Advanced Ingredient Data

[{"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": ""}, {"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away [1-800-222-1222]", "Purpose": "Antihistamine", "Warnings": "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. If pregnant or breast-feeding, ask a health professional before use.", "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", "Questions?": "call toll-free 1-866-933-6337", "Other information": "store between 20° and 25°C (68° and 77°F) protect from excessive moisture", "Inactive ingredients": "lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch, glycolate.", "Active ingredient (in each tablet)": "Loratadine 10 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:38.875616 · Updated: 2026-03-14T23:02:19.584479