Children's Loratadine Oral Solution

Drug Facts

Composition & Product

Active Ingredients

Loratadine (5 mg)

Inactive Ingredients

Butylated Hydroxyanisole Glycerin Polyethylene Glycol, Unspecified Sorbitol Phosphoric Acid Propylene Glycol Water Sodium Benzoate Sodium Phosphate, Monobasic, Dihydrate

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

ANDA Active Since 2016-12-08

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. (1-800-222-1222)

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 breast-feeding, ask a health professional before use.

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

Questions?

Call 1-866-923-4914

Other Information

each teaspoonful contains: sodium 5 mg
do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
store between 20° and 25°C (68° and 77°F)
see bottom panel for lot number and expiration date

Inactive Ingredients

bubble gum flavor, butylated hydroxyanisole, glycerin, maltitol solution, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sucralose powder

Active Ingredient (in Each 5 Ml Teaspoonful)

Loratadine 5 mg

Principal Display Panel 120 Ml Bottle Carton

Compare to the

active ingredient

in Children's Claritin^®*

NDC 51672-2108-8

Children's

Loratadine

Oral Solution

USP, 5 mg/5 mL

(Antihistamine) ALLERGY

Non-Drowsy^†

Indoor & Outdoor Allergies

SUGAR FREE

24

Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Ages 2 years and older

Dosing Cup

Enclosed

Bubble Gum

Flavor

^†When taken as directed.

See Drug Facts Panel.

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

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. (1-800-222-1222)

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 breast-feeding, ask a health professional before use.

Purpose

Antihistamine

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

Questions?

Call 1-866-923-4914

Other Information (Other information)

each teaspoonful contains: sodium 5 mg
do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
store between 20° and 25°C (68° and 77°F)
see bottom panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

bubble gum flavor, butylated hydroxyanisole, glycerin, maltitol solution, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sucralose powder

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

Loratadine 5 mg

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

Compare to the

active ingredient

in Children's Claritin^®*

NDC 51672-2108-8

Children's

Loratadine

Oral Solution

USP, 5 mg/5 mL

(Antihistamine) ALLERGY

Non-Drowsy^†

Indoor & Outdoor Allergies

SUGAR FREE

24

Hour

Relief of:

Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose

Ages 2 years and older

Dosing Cup

Enclosed

Bubble Gum

Flavor

^†When taken as directed.

See Drug Facts Panel.

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 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. (1-800-222-1222)", "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 breast-feeding, ask a health professional before use.", "Purpose": "Antihistamine", "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", "Questions?": "Call 1-866-923-4914", "Other information": "each teaspoonful contains: sodium 5 mg do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing. store between 20° and 25°C (68° and 77°F) see bottom panel for lot number and expiration date", "Inactive ingredients": "bubble gum flavor, butylated hydroxyanisole, glycerin, maltitol solution, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sucralose powder", "Active ingredient (in each 5 mL teaspoonful)": "Loratadine 5 mg", "PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton": "Compare to the active ingredient in Children's Claritin ® * NDC 51672-2108-8 Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) ALLERGY Non-Drowsy † Indoor & Outdoor Allergies SUGAR FREE 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Ages 2 years and older Dosing Cup Enclosed Bubble Gum Flavor † When taken as directed. See Drug Facts Panel. 4 FL OZ (120 mL)"}

Children's Loratadine Oral Solution

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information