414 - Xl-3 Allergy

414 - Xl-3 Allergy
SPL v1
SPL
SPL Set ID 059a6e72-888e-4cb3-8722-4c3acbd6b4b0
Route
ORAL
Published
Effective Date 2024-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (10 mg)
Inactive Ingredients
Lactose Monohydrate Magnesium Stearate Starch, Corn Sodium Starch Glycolate Type A

Identifiers & Packaging

Pill Appearance
Imprint: G;10 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2024-04-10
Description

Loratadine 10mg

Purpose

 Antihistamine

Medication Information

Purpose

 Antihistamine

Description

Loratadine 10mg

Use(s)

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 
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

Do Not Use

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

Other Information
  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture
  • do not use if blister unit is torn or open
Questions/comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Active Ingredient(s)

Loratadine 10mg

Inactive Ingredients

lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate

Principal Display Panel
XL - 3 Allergy
When Using This Product

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

Ask A Doctor Before Use If

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

Stop Use and Ask A Doctor If

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

If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Structured Label Content

Use(s)

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

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 (Other information)
  • store between 20° to 25°C (68° to 77°F)
  • protect from excessive moisture
  • do not use if blister unit is torn or open
Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday through Friday 9AM - 5PM

Active Ingredient(s) (Active ingredient(s))

Loratadine 10mg

Inactive Ingredients (Inactive ingredients)

lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate

Principal Display Panel
XL - 3 Allergy
When Using This Product (When using this product)

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

Ask A Doctor Before Use If (Ask a doctor before use if)

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

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

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

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

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

In case of accidental overdose, contact a doctor or Poison Control Center (1-800-222-1222) right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:57.006656 · Updated: 2026-03-14T23:02:46.668637