Allervarx Loratadine Orally Disintegrating Tablets Usp

Allervarx Loratadine Orally Disintegrating Tablets Usp
SPL v3
SPL
SPL Set ID 885e81ae-5ea3-4d14-8666-8c2698767014
Route
ORAL
Published
Effective Date 2024-12-27
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

Marketing Status
ANDA Active Since 2022-05-30
Description

Loratadine 10 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

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
Section 51945-4

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 

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

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?

1-888-278-1784 - Our Medical Information center shall operate between 9:00 AM to 5:00 PM EST from Monday through Friday (business hours). Queries received outside business hours shall reach voice mail and shall be attended on next business day.

When Using This Product

do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask A Doctor If

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

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children 

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet)

Loratadine 10 mg

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

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 51945-4 (51945-4)

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 

Do Not Use (Do not use)

if you have ever had an allergic reaction to this product or any of its ingredients.

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?)

1-888-278-1784 - Our Medical Information center shall operate between 9:00 AM to 5:00 PM EST from Monday through Friday (business hours). Queries received outside business hours shall reach voice mail and shall be attended on next business day.

When Using This Product (When using this product)

do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a health professional before use.

Keep Out of Reach of Children  (Keep out of reach of children )

In case of overdose, get medical help or contact a Poison Control Center right away.

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

Loratadine 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver or kidney disease. Your doctor should determine if you need a different dose.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:05.854085 · Updated: 2026-03-14T23:06:25.914429