Loratadine

Drug Facts

Composition & Product

Active Ingredients

Loratadine (5 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

ANDA Active Since 2023-08-01

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

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

Active Ingredient (in Each 5 Ml Teaspoonful)

Loratadine 5 mg

Principal Display Panel 120 Ml Bottle Carton

NDC 70677-1057-1

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

Non-Drowsy**

WARNING: Contains sodium metabisulfite,

a sulfite that may cause allergic-type reactions.

Ages 2 years & older

Dye Free

FRUIT 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)

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

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 70677-1057-1

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

Non-Drowsy**

WARNING: Contains sodium metabisulfite,

a sulfite that may cause allergic-type reactions.

Ages 2 years & older

Dye Free

FRUIT 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)

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Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information