Loratadine Oral Solution Usp 5 Mg/5 Ml

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 2018-06-29

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	10 mL daily; do not take more than 10 mL in 24 hours
children 2 to under 6 years of age	5 mL daily; do not take more than 5 mL 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 5 mL contains: 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

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road,

East Windsor, NJ 08520

Made in India

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 Carton (60 Ml)

AUROHEALTH

NDC 58602-423-11

^#Compare to the

active ingredient in

children’s Claritin^®

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

Indoor & Outdoor Allergies

Dosing Cup Included

Dye-Free

Contains sodium

metabisulfite, a sulfite

that may cause

allergic-type reactions.

* When taken as directed.

See Drug Facts Panel.

Grape

Flavor

2 FL OZ (60 mL)

Package Label Principal Display Panel 5 Mg/5 Ml (60 Ml Bottle)

AUROHEALTH

NDC 58602-423-11

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

2 FL OZ (60 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	10 mL daily; do not take more than 10 mL in 24 hours
children 2 to under 6 years of age	5 mL daily; do not take more than 5 mL 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 5 mL contains: 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

Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road,

East Windsor, NJ 08520

Made in India

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 Carton (60 Ml) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL))

AUROHEALTH

NDC 58602-423-11

^#Compare to the

active ingredient in

children’s Claritin^®

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

Indoor & Outdoor Allergies

Dosing Cup Included

Dye-Free

Contains sodium

metabisulfite, a sulfite

that may cause

allergic-type reactions.

* When taken as directed.

See Drug Facts Panel.

Grape

Flavor

2 FL OZ (60 mL)

Package Label Principal Display Panel 5 Mg/5 Ml (60 Ml Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle))

AUROHEALTH

NDC 58602-423-11

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

2 FL OZ (60 mL)

Advanced Ingredient Data

[{"name": "LORATADINE", "unii": "7AJO3BO7QN", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GRAPE", "unii": "6X543N684K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASCORBIC ACID", "unii": "PQ6CK8PD0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALTITOL", "unii": "D65DG142WK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE", "unii": "593YOG76RN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHOSPHORIC ACID", "unii": "E4GA8884NN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM METABISULFITE", "unii": "4VON5FNS3C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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 10 mL daily; do not take more than 10 mL in 24 hours children 2 to under 6 years of age 5 mL daily; do not take more than 5 mL 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 5 mL contains : 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 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India ", "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 Carton (60 mL)": "AUROHEALTH NDC 58602-423-11 # Compare to the active ingredient in children’s Claritin ® 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 Indoor & Outdoor Allergies Dosing Cup Included Dye-Free Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. * When taken as directed. See Drug Facts Panel. Grape Flavor 2 FL OZ (60 mL)", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle)": "AUROHEALTH NDC 58602-423-11 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 2 FL OZ (60 mL)"}

Loratadine Oral Solution Usp 5 Mg/5 Ml

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information