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
Purpose

Antihistamine

Description

Drug Facts

Medication Information

Warnings

Active Ingredient

Loratadine 10 mg

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
Purpose

Antihistamine

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

Description

Drug Facts

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.

Questions Or Comments?

1-877-244-9825

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

Warnings

Active Ingredient (Active ingredient (in each tablet))

Loratadine 10 mg

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
Purpose

Antihistamine

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

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.

Questions Or Comments? (Questions or comments?)

1-877-244-9825

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

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