Loratadine Tablet 10 Mg

SPL v9

SPL

SPL Set ID 679164cc-7505-7ed4-13fe-87f06cb777d8

Route

ORAL

Published

Effective Date 2024-09-26

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 Completed Since 2005-01-24 Until 2022-06-30

Description

Drug Facts

Purpose

Antihistamine

Medication Information

Warnings and Precautions

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

Purpose

Antihistamine

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

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

Principal Display Panel 10 Mg

APOTEX CORP. NDC 60505-0147-1

Loratadine Tablets 10 mg

Non-Drowsy*

Antihistamine/Original Prescription Strength

^†Compare to the active ingredient in Claritin^® Tablets

Indoor & Outdoor Allergies

24 hour

Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

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

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

Principal Display Panel 10 Mg (PRINCIPAL DISPLAY PANEL - 10 mg)

APOTEX CORP. NDC 60505-0147-1

Loratadine Tablets 10 mg

Non-Drowsy*

Antihistamine/Original Prescription Strength

^†Compare to the active ingredient in Claritin^® Tablets

Indoor & Outdoor Allergies

24 hour

Relief of

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

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", "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", "PRINCIPAL DISPLAY PANEL - 10 mg": "APOTEX CORP. NDC 60505-0147-1 Loratadine Tablets 10 mg Non-Drowsy* Antihistamine/ Original Prescription Strength † Compare to the active ingredient in Claritin ® Tablets Indoor & Outdoor Allergies 24 hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose", "Active ingredient (in each tablet)": "Loratadine 10 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:03.864839 · Updated: 2026-03-14T23:10:14.816739