Loratadine Oral Solution

Drug Facts

Composition & Product

Active Ingredients

Loratadine (5 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

ANDA Active Since 2023-07-19

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

Section 50567-7

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

Section 50569-3

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1

Do not useif 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 833-358-6431

Other Information

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

Inactive Ingredients

butylated hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, sucralose powder.

Active Ingredient (in Each 5 Ml Teaspoonful)

Loratadine 5 mg

Principal Display Panel 120 Ml Bottle Carton

NDC 70677-1058-1

COMPARE TO CHILDREN'S

CLARITIN ^®ACTIVE INGREDIENT*

Foster & Thrive™

ORIGINAL PRESCRIPTION STRENGTH

Children's

Allergy

Loratadine Oral Solution

USP, 5 mg/5 mL

ANTIHISTAMINE Allergy

Indoor & Outdoor Allergies

24 hour relief of:

Runny Nose
Itchy, Watery Eyes
Sneezing
Itchy Throat or Nose

Sugar Free | Non-Drowsy**

Ages 2 years & older

Dye Free

GRAPE FLAVOR

DOSING CUP ENCLOSED

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

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Section 50570-1 (50570-1)

Do not useif 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 833-358-6431

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

butylated hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, 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)

NDC 70677-1058-1

COMPARE TO CHILDREN'S

CLARITIN ^®ACTIVE INGREDIENT*

Foster & Thrive™

ORIGINAL PRESCRIPTION STRENGTH

Children's

Allergy

Loratadine Oral Solution

USP, 5 mg/5 mL

ANTIHISTAMINE Allergy

Indoor & Outdoor Allergies

24 hour relief of:

Runny Nose
Itchy, Watery Eyes
Sneezing
Itchy Throat or Nose

Sugar Free | Non-Drowsy**

Ages 2 years & older

Dye Free

GRAPE FLAVOR

DOSING CUP ENCLOSED

** 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 833-358-6431", "Other information": "do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing. see bottom panel for lot number and expiration date store between 20° and 25°C (68° and 77°F)", "Inactive ingredients": "butylated hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, sucralose powder.", "Active ingredient (in each 5 mL teaspoonful)": "Loratadine 5 mg", "PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton": "NDC 70677-1058-1 COMPARE TO CHILDREN'S CLARITIN ® ACTIVE INGREDIENT* Foster & Thrive™ ORIGINAL PRESCRIPTION STRENGTH Children's Allergy Loratadine Oral Solution USP, 5 mg/5 mL ANTIHISTAMINE Allergy Indoor & Outdoor Allergies 24 hour relief of: Runny Nose Itchy, Watery Eyes Sneezing Itchy Throat or Nose Sugar Free | Non-Drowsy** Ages 2 years & older Dye Free GRAPE FLAVOR DOSING CUP ENCLOSED ** WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL. 4 FL OZ (120 mL)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information