Loratidine Orally Disintegrating Tablets, Usp

Loratidine Orally Disintegrating Tablets, Usp
SPL v1
SPL
SPL Set ID 9c168fbb-6668-4a9d-9c7e-d3441e60eb95
Route
ORAL
Published
Effective Date 2024-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Polysorbate 80 Mannitol Pullulan

Identifiers & Packaging

Pill Appearance
Imprint: M24 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
ANDA Active Since 2024-05-07
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
  • 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 ifan allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

When using this productdo not use more than directed. Taking more than recommended may cause drowsiness.

Section 50569-3

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

Section 50570-1

Do not useif 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
  • Place 1 tablet on tongue; tablet disentigrates with or without water.
adults and children 6 years and over 1 tablet daily; do not use more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers who have liver or kidney disease ask a doctor
Other Information
  • safety sealed: do not use if the individual blister unit printed with Loratadine orally disintegrating tablet is open or torn
  • store at 20-25°C (68-77°F)
  • use tablet immediately after opening individual blister
  • complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration
Inactive Ingredients

anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan

Questions Or Comments?

Call Toll-free weekdays 9 AM to 5 PM EST at 1-888-375-3784

Active Ingredient (in Each Tablet)

Loratadine 10 mg

Principal Display Panel 10 Mg Tablet Blister Pack Carton

NEW FORMULA

NON-DROWSY*

ALLERGY RELIEF

Loratadine Orally Disintegrating Tablet USP, 10 mg

Antihistamine

Indoor/Outdoor

ALLERGIES

24 Hour Relief of

Sneezing, Runny Nose

Itchy/Watery Eyes

Itchy Throat or Nose

Melts In Your Mouth

FRESH MINT Flavor

*When taken as directed. See Drug Facts Panel.

60 Orally Disintegrating Tablets

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 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 ifan allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

When using this productdo not use more than directed. Taking more than recommended may cause drowsiness.

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

Do not useif 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
  • Place 1 tablet on tongue; tablet disentigrates with or without water.
adults and children 6 years and over 1 tablet daily; do not use more than 1 tablet in 24 hours
children under 6 years of age ask a doctor
consumers who have liver or kidney disease ask a doctor
Other Information (Other information)
  • safety sealed: do not use if the individual blister unit printed with Loratadine orally disintegrating tablet is open or torn
  • store at 20-25°C (68-77°F)
  • use tablet immediately after opening individual blister
  • complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan

Questions Or Comments? (Questions or comments?)

Call Toll-free weekdays 9 AM to 5 PM EST at 1-888-375-3784

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

Loratadine 10 mg

Principal Display Panel 10 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 10 mg Tablet Blister Pack Carton)

NEW FORMULA

NON-DROWSY*

ALLERGY RELIEF

Loratadine Orally Disintegrating Tablet USP, 10 mg

Antihistamine

Indoor/Outdoor

ALLERGIES

24 Hour Relief of

Sneezing, Runny Nose

Itchy/Watery Eyes

Itchy Throat or Nose

Melts In Your Mouth

FRESH MINT Flavor

*When taken as directed. See Drug Facts Panel.

60 Orally Disintegrating Tablets

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:03.614694 · Updated: 2026-03-14T23:02:54.359020