Loratadine Oral Solution Usp, 5mg/5 Ml (otc)

Drug Facts

Composition & Product

Active Ingredients

Loratadine (5 mg)

Inactive Ingredients

Edetate Disodium Glycerin Maltitol Sodium Phosphate, Monobasic Sorbitol Phosphoric Acid Propylene Glycol Water Sodium Benzoate Sucralose

Identifiers & Packaging

Pill Appearance

Color: yellow

Marketing Status

ANDA Active Since 2021-05-07

Medication Information

Purpose

Antihistamine

Description

(in each 5 mL teaspoonful) Loratadine USP, 5mg

Use(s)

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

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

Do Not Use

if you have ever had an allergic reaction to this product or any of its ingredients.

Other Information

• Sodium Free

• do not use if tape imprinted with 'SEALED FORYOUR PROTECTION' on top and bottom flaps of carton is not intact

• store between 20° to 25°C (68° to 77°F)

Active Ingredient(s)

(in each 5 mL teaspoonful)

Loratadine USP, 5mg

Inactive Ingredients

ART grape flavor, edetate disodium dihydrate, glycerin, maltitol solution, monobasic sodium phosphate, non crystallizing sorbitol solution, phosphoric acid, propylene glycol, purified water, sodium benzoate and sucralose

Questions Or Comments?

Call 1-888-588-1418

Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA.

Principal Display Panel

Loratadine Oral Solution USP, 5 mg/5mL 120 mL Carton Label

When Using This Product

do not take more than directed. Taking more than directed may cause drowsiness.

Stop Use and Ask A Doctor If

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

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Have

liver or kidney disease. Your doctor should determine if you need a different dose.

Structured Label Content

Use(s) (USE(S))

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

Purpose (PURPOSE)

Antihistamine

Directions (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

Do Not Use (DO NOT USE)

if you have ever had an allergic reaction to this product or any of its ingredients.

Other Information (OTHER INFORMATION)

• Sodium Free

• do not use if tape imprinted with 'SEALED FORYOUR PROTECTION' on top and bottom flaps of carton is not intact

• store between 20° to 25°C (68° to 77°F)

Active Ingredient(s) (ACTIVE INGREDIENT(S))

(in each 5 mL teaspoonful)

Loratadine USP, 5mg

Inactive Ingredients (INACTIVE INGREDIENTS)

ART grape flavor, edetate disodium dihydrate, glycerin, maltitol solution, monobasic sodium phosphate, non crystallizing sorbitol solution, phosphoric acid, propylene glycol, purified water, sodium benzoate and sucralose

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Call 1-888-588-1418

Distributed by:

Camber Consumer Care, Inc.

Piscataway, NJ 08854, USA.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Loratadine Oral Solution USP, 5 mg/5mL 120 mL Carton Label

When Using This Product (WHEN USING THIS PRODUCT)

do not take more than directed. Taking more than directed may cause drowsiness.

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.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)

liver or kidney disease. Your doctor should determine if you need a different dose.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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