Loratadine Oral Solution Usp 5 Mg/5 Ml

Loratadine Oral Solution Usp 5 Mg/5 Ml
SPL v2
SPL
SPL Set ID ab820f80-b5fc-7896-e053-2995a90a4b1c
Route
ORAL
Published
Effective Date 2020-07-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Loratadine (5 mg)
Inactive Ingredients
Grape Ascorbic Acid Glycerin Maltitol Sodium Phosphate, Monobasic, Monohydrate Phosphoric Acid Propylene Glycol Water Sodium Benzoate Sodium Metabisulfite Sorbitol Sucralose

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
ANDA Active Since 2020-07-31
Description

Active ingredient (in each 5 mL) Loratadine USP 5 mg

Purpose

Antihistamine

Medication Information

Purpose

Antihistamine

Description

Active ingredient (in each 5 mL) Loratadine USP 5 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
Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Directions

  • use only with enclosed dosing cup
  • mL= milliliter

adults and children 6 years and over 10mL daily; do not take more than 10mL in 24 hours
children 2 to under 6 years of age 5mL daily; do not take more than 5mL in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

Drug Facts

Active ingredient (in each 5 mL)



Loratadine USP 5 mg

Other Information
  • each 5mLcontains: sodium 6 mg
  • do not use if carton is opened, or if cap safety seal is broken or missing.
  • store at 20° to 25°C (68° to 77°F)
Inactive Ingredients

artificial flavors, ascorbic acid, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose.

Questions Or Comments?

Call 1-855-274-4122







Manufactured by:



Aurobindo Pharma Limited



Hyderabad-500 090, India

For BluePoint Laboratories





Code:TS/DRUGS/19/1993

Revised: 04/2025

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 (1-800-222-1222) right away.

Ask A Doctor Before Use If You Have

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

Package Label Principal Display Panel 5 Mg/5 Ml (120 Ml Bottle)

NDC 68001-449-98







Ages



2 years



and older

Loratadine



Oral Solution USP



5 mg/5 mL







Antihistamine



Non-Drowsy*







24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Do not use if carton is opened,



or if cap safety seal is broken



or missing.

  • Dye-Free
  • Sugar-Free
  • Alcohol Free

Indoor & Outdoor Allergies

Contains sodium metabisulfite,



a sulfite that may cause



allergic-type reactions.

* When taken as directed. See Drug Facts Panel.







Grape Flavor







4FL OZ (120 mL)



Package Label Principal Display Panel 5 Mg/5 Ml Carton (120 Ml)

NDC 68001-449-98

#Compare to the



active ingredient in



children’s Claritin®





Ages

2years



and older







Loratadine



Oral Solution USP



5 mg/5 mL







Antihistamine







Non-Drowsy*







24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy,watery Eyes
  • Itchy Throat or Nose

Indoor & Outdoor Allergies







Dosing Cup Included

  • Dye-Free
  • Sugar-Free
  • Alcohol Free

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

* When taken as directed.

See Drug Facts Panel.







Grape

Flavor







4 FL OZ (120 mL)









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
Purpose

Antihistamine

Warnings

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

Directions

  • use only with enclosed dosing cup
  • mL= milliliter

adults and children 6 years and over 10mL daily; do not take more than 10mL in 24 hours
children 2 to under 6 years of age 5mL daily; do not take more than 5mL in 24 hours
children under 2 years of age ask a doctor
consumers with liver or kidney disease ask a doctor

Drug Facts

Active ingredient (in each 5 mL)



Loratadine USP 5 mg

Other Information (Other information)
  • each 5mLcontains: sodium 6 mg
  • do not use if carton is opened, or if cap safety seal is broken or missing.
  • store at 20° to 25°C (68° to 77°F)
Inactive Ingredients (Inactive ingredients)

artificial flavors, ascorbic acid, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose.

Questions Or Comments? (Questions or comments?)

Call 1-855-274-4122







Manufactured by:



Aurobindo Pharma Limited



Hyderabad-500 090, India

For BluePoint Laboratories





Code:TS/DRUGS/19/1993

Revised: 04/2025

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 (1-800-222-1222) right away.

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.

Package Label Principal Display Panel 5 Mg/5 Ml (120 Ml Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (120 mL Bottle))

NDC 68001-449-98







Ages



2 years



and older

Loratadine



Oral Solution USP



5 mg/5 mL







Antihistamine



Non-Drowsy*







24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Do not use if carton is opened,



or if cap safety seal is broken



or missing.

  • Dye-Free
  • Sugar-Free
  • Alcohol Free

Indoor & Outdoor Allergies

Contains sodium metabisulfite,



a sulfite that may cause



allergic-type reactions.

* When taken as directed. See Drug Facts Panel.







Grape Flavor







4FL OZ (120 mL)



Package Label Principal Display Panel 5 Mg/5 Ml Carton (120 Ml) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (120 mL))

NDC 68001-449-98

#Compare to the



active ingredient in



children’s Claritin®





Ages

2years



and older







Loratadine



Oral Solution USP



5 mg/5 mL







Antihistamine







Non-Drowsy*







24 Hour Relief of:

  • Sneezing
  • Runny Nose
  • Itchy,watery Eyes
  • Itchy Throat or Nose

Indoor & Outdoor Allergies







Dosing Cup Included

  • Dye-Free
  • Sugar-Free
  • Alcohol Free

Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions.

* When taken as directed.

See Drug Facts Panel.







Grape

Flavor







4 FL OZ (120 mL)









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Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:08.595143 · Updated: 2026-03-14T23:08:46.104923