First Aid Direct Allergy Relief

First Aid Direct Allergy Relief
SPL v2
SPL
SPL Set ID 6b43e5a5-30a8-46ca-a44d-1e1abf567b51
Route
ORAL
Published
Effective Date 2025-09-23
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

Marketing Status
ANDA Active Since 2021-10-20

Description

Loratadine 10 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Loratadine 10 mg

Uses

temporatily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose 
  • itchy, watery eyes
  • sneezing
  • iching of the nose or throat
Warnings

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

Questions?

1-800-327-2704 Monday - Friday 8:00am - 5:00pm (CDT)

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

lactose monohydrate, magensium stearate, pregelatinized starch, sodium startch glycolate

Principal Display Panel

Original Prescription Strength

Non-Drowsy*

Allergy Relief

Loratadine Tablets, 10 mg - Antihistamine

Indoor & Outdoor Allergies

†Compare to active ingredient of Claritin®

Relief of:

  • sneezing 
  • runny nose
  • itchy, watery eyes
  • itchy throat or nose

24 Hour

Actual Size

20 TABLETS 

*When taken as directed. See drug facts panel

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.

Ask A Doctor Before Use If You

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

If Pregnant Or Breast Feeding,

ask a health professional before use

Keep Out of Reach of Children.

In case of accidental overdose, contact a doctor or Poison Control Center immediately. 

Active Ingredient (in Each Tablet)

Loratadine 10 mg


Structured Label Content

Uses

temporatily relieves these symptoms due to hay fever or other upper respiratory allergies:

  • runny nose 
  • itchy, watery eyes
  • sneezing
  • iching of the nose or throat
Purpose

Antihistamine

Warnings

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

Questions?

1-800-327-2704 Monday - Friday 8:00am - 5:00pm (CDT)

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

lactose monohydrate, magensium stearate, pregelatinized starch, sodium startch glycolate

Principal Display Panel

Original Prescription Strength

Non-Drowsy*

Allergy Relief

Loratadine Tablets, 10 mg - Antihistamine

Indoor & Outdoor Allergies

†Compare to active ingredient of Claritin®

Relief of:

  • sneezing 
  • runny nose
  • itchy, watery eyes
  • itchy throat or nose

24 Hour

Actual Size

20 TABLETS 

*When taken as directed. See drug facts panel

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.

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

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

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 accidental overdose, contact a doctor or Poison Control Center immediately. 

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

Loratadine 10 mg


Advanced Ingredient Data


Raw Label Data

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