Childrens Loratadine

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 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 breast-feeding, 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

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

Stop Use and Ask A Doctor If

an allergic reaction to this product occurs. Seek medical help right away.

side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Active Ingredient (in Each 5 Ml)

Loratadine 5 mg

Principal Display Panel 120 Ml Bottle Carton

NDC 33261-908-01

Compare to the

active ingredient

in Claritin^®*

GRAPE

FLAVOR

Original

Prescription Strength

Ages two years and older

Children's

Loratadine

Syrup

(Loratadine

Oral Solution)

5 mg/5 mL

Antihistamine

Grape Flavored Syrup

24 hour

Non-Drowsy ^†

Allergy Relief

Relief of:

Sneezing; Runny Nose,

Itchy, Watery Eyes,

Itchy Throat or Nose

4 FL OZ (120 mL)

^† When taken as directed. See Drug Facts Panel.

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 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 breast-feeding, 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

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

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.

side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

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

Loratadine 5 mg

Principal Display Panel 120 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton)

NDC 33261-908-01

Compare to the

active ingredient

in Claritin^®*

GRAPE

FLAVOR

Original

Prescription Strength

Ages two years and older

Children's

Loratadine

Syrup

(Loratadine

Oral Solution)

5 mg/5 mL

Antihistamine

Grape Flavored Syrup

24 hour

Non-Drowsy ^†

Allergy Relief

Relief of:

Sneezing; Runny Nose,

Itchy, Watery Eyes,

Itchy Throat or Nose

4 FL OZ (120 mL)

^† When taken as directed. See Drug Facts Panel.

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.", "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 breast-feeding, 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", "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", "Stop use and ask a doctor if": "an allergic reaction to this product occurs. Seek medical help right away. side effects occur. You may report side effects to FDA at 1-800-FDA-1088.", "Active ingredient (in each 5 mL)": "Loratadine 5 mg", "PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton": "NDC 33261-908-01 Compare to the active ingredient in Claritin ® * GRAPE FLAVOR Original Prescription Strength Ages two years and older Children's Loratadine Syrup (Loratadine Oral Solution) 5 mg/5 mL Antihistamine Grape Flavored Syrup 24 hour Non-Drowsy † Allergy Relief Relief of: Sneezing; Runny Nose, Itchy, Watery Eyes, Itchy Throat or Nose 4 FL OZ (120 mL) † When taken as directed. See Drug Facts Panel."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information