Non-drowsy*claritin ®

SPL v12

SPL

SPL Set ID 660ac9df-f1b1-4c89-94dd-9fae0a013f3c

Route

ORAL

Published

Effective Date 2017-08-04

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Loratadine (10 mg)

Inactive Ingredients

Starch, Corn Lactose Monohydrate Magnesium Stearate

Identifiers & Packaging

Pill Appearance

Imprint: 458;Claritin10 Shape: round Color: white Size: 6 mm Score: 1

Marketing Status

NDA Active Since 1993-04-12

Description

Drug Facts

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Drug Facts

Uses

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

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.

Section 53414-9

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

Inactive Ingredients

corn starch, lactose monohydrate, magnesium stearate

Questions Or Comments?

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

Other Information (bottles)

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
store between 20° to 25°C (68° to 77°F)

Active Ingredient (in Each Tablet)

Loratadine 10 mg

Other Information (blister Foil Units)

safety sealed: do not use if the individual blister unit imprinted with Claritin ^® is open or torn
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Principal Display Panel 10 Tablet Carton

Original Prescription

Strength

Non-Drowsy *

Claritin ^®

loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Indoor & Outdoor

Allergies

* When taken as directed.

See Drug Facts Panel.

10 Tablets

Principal Display Panel 50 Tablet Carton

Non-Drowsy *

Claritin ^®

loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Indoor & Outdoor

Allergies

*When taken as directed.

See Drug Facts Panel.

50 1-Count Pouches

Total 50 Tablets

Principal Display Panel 45 Count Window Box

Original Prescription Strength

Non-Drowsy *

Claritin ®

loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Indoor & Outdoor

Allergies

* When taken as directed.

See Drug Facts Panel.

45 TABLETS

Structured Label Content

Uses

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

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.

Section 53414-9 (53414-9)

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

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

Inactive Ingredients (Inactive ingredients)

corn starch, lactose monohydrate, magnesium stearate

Questions Or Comments? (Questions or comments?)

1-800-CLARITIN (1-800-252-7484) or www.claritin.com

Other Information (bottles) (Other information (Bottles))

Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken
store between 20° to 25°C (68° to 77°F)

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

Loratadine 10 mg

Other Information (blister Foil Units) (Other information (Blister foil units))

safety sealed: do not use if the individual blister unit imprinted with Claritin ^® is open or torn
store between 20° to 25°C (68° to 77°F)
protect from excessive moisture

Principal Display Panel 10 Tablet Carton (PRINCIPAL DISPLAY PANEL - 10 Tablet Carton)

Original Prescription

Strength

Non-Drowsy *

Claritin ^®

loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Indoor & Outdoor

Allergies

* When taken as directed.

See Drug Facts Panel.

10 Tablets

Principal Display Panel 50 Tablet Carton (PRINCIPAL DISPLAY PANEL - 50 Tablet Carton)

Non-Drowsy *

Claritin ^®

loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Indoor & Outdoor

Allergies

*When taken as directed.

See Drug Facts Panel.

50 1-Count Pouches

Total 50 Tablets

Principal Display Panel 45 Count Window Box (PRINCIPAL DISPLAY PANEL - 45 Count Window Box)

Original Prescription Strength

Non-Drowsy *

Claritin ®

loratadine tablets 10 mg/antihistamine

24 Hour

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat or Nose

Indoor & Outdoor

Allergies

* When taken as directed.

See Drug Facts Panel.

45 TABLETS

Advanced Ingredient Data

[{"name": "STARCH, CORN", "unii": "O8232NY3SJ", "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": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "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": "STARCH, CORN", "unii": "O8232NY3SJ", "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": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "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": "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 itchy, watery eyes sneezing itching of the nose or throat", "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.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "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", "Inactive ingredients": "corn starch, lactose monohydrate, magnesium stearate", "Questions or comments?": "1-800-CLARITIN (1-800-252-7484) or www.claritin.com", "Other information (Bottles)": "Tamper-evident: do not use if foil seal under cap, printed with "SEALED for YOUR PROTECTION" is missing, open or broken store between 20° to 25°C (68° to 77°F)", "Active ingredient (in each tablet)": "Loratadine 10 mg", "Other information (Blister foil units)": "safety sealed: do not use if the individual blister unit imprinted with Claritin ® is open or torn store between 20° to 25°C (68° to 77°F) protect from excessive moisture", "PRINCIPAL DISPLAY PANEL - 10 Tablet Carton": "Original Prescription Strength Non-Drowsy * Claritin ® loratadine tablets 10 mg/antihistamine 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Indoor & Outdoor Allergies * When taken as directed. See Drug Facts Panel. 10 Tablets", "PRINCIPAL DISPLAY PANEL - 50 Tablet Carton": "Non-Drowsy * Claritin ® loratadine tablets 10 mg/antihistamine 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Indoor & Outdoor Allergies *When taken as directed. See Drug Facts Panel. 50 1-Count Pouches Total 50 Tablets", "PRINCIPAL DISPLAY PANEL - 45 Count Window Box": "Original Prescription Strength Non-Drowsy * Claritin ® loratadine tablets 10 mg/antihistamine 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Indoor & Outdoor Allergies * When taken as directed. See Drug Facts Panel. 45 TABLETS"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:29.997475 · Updated: 2026-03-14T23:11:02.639613