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 2021-03-15

Medication Information

Purpose

Antihistamine

Description

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

Uses

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

runny nose
sneezing
itchy, watery eyes
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

adults and children 6 years and over	2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age	1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) 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 teaspoonful)

Loratadine USP 5 mg

Other Information

each teaspoonful 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?

1-800-632-6900

DISTRIBUTRD BY THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN INDIA

Code:TS/DRUGS/19/1993

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 (120 Ml)

COMPARE TO the active ingredient of

CHILDRENS'S CLARITIN® **See side panel

NDC 30142-062-24

Kroger^®

Ages 2 Years & Older

Non-Drowsy*

children's

Allergy Relief

Loratadine Oral

Solution USP, 5 mg/5 mL

Antihistamine

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF:

Sneezing; Runny Nose;

Itchy,watery Eyes &

Itchy Throat or Nose

Contains sodium metabisulfite,

a sulfite that may cause

allergic-type reactions.

Dosing

Cup Included

DYE-FREE

Grape Flavor

4 FL OZ (120 mL)

* When taken as directed.

See Drug Facts Panel.

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

NDC 30142-062-24

Kroger^®

Ages 2 Years & Older

children's

Allergy Relief

Loratadine Oral

Solution USP,

5 mg/5 mL

Antihistamine

INDOOR & OUTDOOR

ALLERGIES

24 HOUR

DYE-FREE

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
sneezing
itchy, watery eyes
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

adults and children 6 years and over	2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age	1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) 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 teaspoonful)

Loratadine USP 5 mg

Other Information (Other information)

each teaspoonful 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?)

1-800-632-6900

DISTRIBUTRD BY THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN INDIA

Code:TS/DRUGS/19/1993

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 (120 Ml) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (120 mL))

COMPARE TO the active ingredient of

CHILDRENS'S CLARITIN® **See side panel

NDC 30142-062-24

Kroger^®

Ages 2 Years & Older

Non-Drowsy*

children's

Allergy Relief

Loratadine Oral

Solution USP, 5 mg/5 mL

Antihistamine

INDOOR & OUTDOOR ALLERGIES

24 HOUR RELIEF OF:

Sneezing; Runny Nose;

Itchy,watery Eyes &

Itchy Throat or Nose

Contains sodium metabisulfite,

a sulfite that may cause

allergic-type reactions.

Dosing

Cup Included

DYE-FREE

Grape Flavor

4 FL OZ (120 mL)

* When taken as directed.

See Drug Facts Panel.

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 30142-062-24

Kroger^®

Ages 2 Years & Older

children's

Allergy Relief

Loratadine Oral

Solution USP,

5 mg/5 mL

Antihistamine

INDOOR & OUTDOOR

ALLERGIES

24 HOUR

DYE-FREE

Grape Flavor

4 FL OZ (120 mL)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes 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 adults and children 6 years and over 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours children 2 to under 6 years of age 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) 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 teaspoonful) Loratadine USP 5 mg", "Other information": "each teaspoonful 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?": "1-800-632-6900 DISTRIBUTRD BY THE KROGER CO. CINCINNATI, OHIO 45202 MADE IN INDIA Code:TS/DRUGS/19/1993", "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 (120 mL)": "COMPARE TO the active ingredient of CHILDRENS'S CLARITIN® **See side panel NDC 30142-062-24 Kroger ® Ages 2 Years & Older Non-Drowsy* children's Allergy Relief Loratadine Oral Solution USP, 5 mg/5 mL Antihistamine INDOOR & OUTDOOR ALLERGIES 24 HOUR RELIEF OF: Sneezing; Runny Nose; Itchy,watery Eyes & Itchy Throat or Nose Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. Dosing Cup Included DYE-FREE Grape Flavor 4 FL OZ (120 mL) * When taken as directed. See Drug Facts Panel.", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (120 mL Bottle)": "NDC 30142-062-24 Kroger ® Ages 2 Years & Older children's Allergy Relief Loratadine Oral Solution USP, 5 mg/5 mL Antihistamine INDOOR & OUTDOOR ALLERGIES 24 HOUR DYE-FREE Grape Flavor 4 FL OZ (120 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