Loratidine Orally Disintegrating Tablets, Usp

Loratidine Orally Disintegrating Tablets, Usp
SPL v8
SPL
SPL Set ID 7ed2aec0-4da7-4edc-9998-b96c67c82738
Route
ORAL
Published
Effective Date 2021-05-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: T10 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
ANDA Active Since 2021-08-08
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.

Warnings

Directions
  • place 1 tablet on tongue; tablet disintegrates, with or without water
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 the individual blister unit imprinted with Loratadine Orally Disintegrating Tablet, USP is open or torn
  • store between 20° to 25°C (68° to 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?

1-877-244-9825

Active Ingredient (in Each Tablet)

Loratadine 10 mg

Package Label.principal Display Panel

CVS Health

Indoor & Outdoor Allergies

Children’s



LORATADINE ORALLY



DISINTEGRATING



TABLETS USP, 10 mg

Antihistamine

Allergy Relief

Non-Drowsy*

Original Prescription Strength

24 hour relief of:



Sneezing; Runny nose; Itchy,



watery eyes; Itchy throat or nose

Ages 6 yrs & older



30 ORALLY



DISINTEGRATING



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

Warnings

Directions
  • place 1 tablet on tongue; tablet disintegrates, with or without water
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 the individual blister unit imprinted with Loratadine Orally Disintegrating Tablet, USP is open or torn
  • store between 20° to 25°C (68° to 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?)

1-877-244-9825

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

Loratadine 10 mg

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

CVS Health

Indoor & Outdoor Allergies

Children’s



LORATADINE ORALLY



DISINTEGRATING



TABLETS USP, 10 mg

Antihistamine

Allergy Relief

Non-Drowsy*

Original Prescription Strength

24 hour relief of:



Sneezing; Runny nose; Itchy,



watery eyes; Itchy throat or nose

Ages 6 yrs & older



30 ORALLY



DISINTEGRATING



TABLETS

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:02:38.088225 · Updated: 2026-03-14T23:02:18.218337