Loratadine Tablet 10 Mg

SPL v12

SPL

SPL Set ID 04a49370-7617-4097-9921-75cbd9fc4420

Route

ORAL

Published

Effective Date 2020-01-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Silicon Dioxide Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

Imprint: LOR;10;APO Shape: oval Color: white Size: 8 mm Score: 1

Marketing Status

ANDA Active Since 2005-01-24

Description

Drug Facts

Purpose

Antihistamine

How Supplied

Product: 50090-0838 NDC: 50090-0838-0 10 TABLET in a BOTTLE NDC: 50090-0838-1 20 TABLET in a BOTTLE NDC: 50090-0838-3 15 TABLET in a BOTTLE NDC: 50090-0838-4 30 TABLET in a BOTTLE NDC: 50090-0838-5 90 TABLET in a BOTTLE NDC: 50090-0838-6 7 TABLET in a BOTTLE

Medication Information

Warnings and Precautions

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

Purpose

Antihistamine

How Supplied

Product: 50090-0838

NDC: 50090-0838-0 10 TABLET in a BOTTLE

NDC: 50090-0838-1 20 TABLET in a BOTTLE

NDC: 50090-0838-3 15 TABLET in a BOTTLE

NDC: 50090-0838-4 30 TABLET in a BOTTLE

NDC: 50090-0838-5 90 TABLET in a BOTTLE

NDC: 50090-0838-6 7 TABLET in a BOTTLE

Description

Drug Facts

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 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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.

Warnings

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

Loratadine

Other Information

safety sealed: do not use if induction seal, with "Lift N Peel" tab, under cap is broken or missing
store between 2°C and 30°C (36°F and 86°F)
protect from excessive moisture

Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Questions Or Comments?

Call 1-800-706-5575, weekdays, 8:30 am - 5:00 pm Eastern Standard Time

Manufactured by:	Manufactured for:
Apotex Inc.	Apotex Corp.
Toronto, Ontario	Weston, Florida
Canada M9L 1T9	33326

Revised: August 2018

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

Warnings and Precautions (34071-1)

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

Section 42229-5 (42229-5)

Drug Facts

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.

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.

Purpose

Antihistamine

Warnings

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

Loratadine

How Supplied (HOW SUPPLIED)

Product: 50090-0838

NDC: 50090-0838-0 10 TABLET in a BOTTLE

NDC: 50090-0838-1 20 TABLET in a BOTTLE

NDC: 50090-0838-3 15 TABLET in a BOTTLE

NDC: 50090-0838-4 30 TABLET in a BOTTLE

NDC: 50090-0838-5 90 TABLET in a BOTTLE

NDC: 50090-0838-6 7 TABLET in a BOTTLE

Other Information (Other information)

safety sealed: do not use if induction seal, with "Lift N Peel" tab, under cap is broken or missing
store between 2°C and 30°C (36°F and 86°F)
protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose

Questions Or Comments? (Questions or comments?)

Call 1-800-706-5575, weekdays, 8:30 am - 5:00 pm Eastern Standard Time

Manufactured by:	Manufactured for:
Apotex Inc.	Apotex Corp.
Toronto, Ontario	Weston, Florida
Canada M9L 1T9	33326

Revised: August 2018

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

Loratadine 10 mg

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CROSCARMELLOSE SODIUM", "unii": "M28OL1HH48", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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", "34071-1": "If pregnant or breast-feeding, ask a health professional before use.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center 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.", "Purpose": "Antihistamine", "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", "HOW SUPPLIED": "Product: 50090-0838 NDC: 50090-0838-0 10 TABLET in a BOTTLE NDC: 50090-0838-1 20 TABLET in a BOTTLE NDC: 50090-0838-3 15 TABLET in a BOTTLE NDC: 50090-0838-4 30 TABLET in a BOTTLE NDC: 50090-0838-5 90 TABLET in a BOTTLE NDC: 50090-0838-6 7 TABLET in a BOTTLE", "Other information": "safety sealed: do not use if induction seal, with "Lift N Peel" tab, under cap is broken or missing store between 2°C and 30°C (36°F and 86°F) protect from excessive moisture", "Inactive ingredients": "colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose", "Questions or comments?": "Call 1-800-706-5575 , weekdays, 8:30 am - 5:00 pm Eastern Standard Time Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 33326 Revised: August 2018", "Active ingredient (in each tablet)": "Loratadine 10 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:01.844348 · Updated: 2026-03-14T22:55:53.187482