Children's Loratadine Syrup

Drug Facts

Composition & Product

Active Ingredients

Loratadine (5 mg)

Inactive Ingredients

Citric Acid Monohydrate Glycerin Propylene Glycol Water Sodium Benzoate Sodium Metabisulfite Sucrose

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

ANDA Active Since 2004-08-20

Medication Information

Purpose

Antihistamine

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3

Ask a doctor before use if you have liver or kidney disease.

Your doctor should determine if you need a different dose.

Section 50570-1

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

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Directions

adults and children 6 years and over	2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
children 2 to under 6 years of age	1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours
consumers with liver or kidney disease	ask a doctor

Questions?

Call 1-866-923-4914

Other Information

safety sealed: do not use if imprinted safety seal is torn or missing
store between 2° and 25°C (36° and 77°F)

Inactive Ingredients

artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

Active Ingredient (in Each 5 Ml)

Loratadine 5 mg

Principal Display Panel 118 Ml Bottle Carton

NDC 11673-914-26

children's

loratadine syrup

loratadine oral solution, 5 mg/5 mL

antihistamine

Compare to active ingredient in

Children's Claritin^®*

24-hour, non-drowsy**

allergy relief of sneezing/runny nose/

itchy, watery eyes/itchy throat or nose

alcohol free, dye free

spanish instructions enclosed

dosage cup enclosed

**when taken as directed

see drug facts panel

24

HOUR

RELIEF

up&up

GRAPE

FLAVOR

AGE

2+

YEARS

4 FL OZ (118 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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

Section 50567-7 (50567-7)

When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Section 50569-3 (50569-3)

Ask a doctor before use if you have liver or kidney disease.

Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

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

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Purpose

Antihistamine

Directions

adults and children 6 years and over	2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours
children 2 to under 6 years of age	1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours
consumers with liver or kidney disease	ask a doctor

Questions?

Call 1-866-923-4914

Other Information (Other information)

safety sealed: do not use if imprinted safety seal is torn or missing
store between 2° and 25°C (36° and 77°F)

Inactive Ingredients (Inactive ingredients)

artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Loratadine 5 mg

Principal Display Panel 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

NDC 11673-914-26

children's

loratadine syrup

loratadine oral solution, 5 mg/5 mL

antihistamine

Compare to active ingredient in

Children's Claritin^®*

24-hour, non-drowsy**

allergy relief of sneezing/runny nose/

itchy, watery eyes/itchy throat or nose

alcohol free, dye free

spanish instructions enclosed

dosage cup enclosed

**when taken as directed

see drug facts panel

24

HOUR

RELIEF

up&up

GRAPE

FLAVOR

AGE

2+

YEARS

4 FL OZ (118 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 itchy, watery eyes sneezing itching of the nose or throat", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.", "50567-7": "When using this product do not take more than directed. Taking more than directed may cause drowsiness.", "50569-3": "Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.", "50570-1": "Do not use if you have ever had an allergic reaction to this product or any of its ingredients.", "53414-9": "If pregnant or breastfeeding, ask a health professional before use.", "Purpose": "Antihistamine", "Directions": "adults and children 6 years and over 2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours children 2 to under 6 years of age 1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours consumers with liver or kidney disease ask a doctor", "Questions?": "Call 1-866-923-4914", "Other information": "safety sealed: do not use if imprinted safety seal is torn or missing store between 2° and 25°C (36° and 77°F)", "Inactive ingredients": "artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucrose", "Active ingredient (in each 5 mL)": "Loratadine 5 mg", "PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton": "NDC 11673-914-26 children's loratadine syrup loratadine oral solution, 5 mg/5 mL antihistamine Compare to active ingredient in Children's Claritin ® * 24-hour, non-drowsy** allergy relief of sneezing/runny nose/ itchy, watery eyes/itchy throat or nose alcohol free, dye free spanish instructions enclosed dosage cup enclosed **when taken as directed see drug facts panel 24 HOUR RELIEF up&up GRAPE FLAVOR AGE 2+ YEARS 4 FL OZ (118 mL)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information