Childrens Allergy LORATADINE WAL-MART STORES INC FDA Approved Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat
FunFoxMeds bottle
Substance Loratadine
Route
ORAL
Applications
ANDA201865

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each 5 mL teaspoonful) Loratadine 5 mg
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
Strengths
5 ml 5 mg
Quantities
120 ml 5 ml
Treats Conditions
Uses Temporarily Relieves These Symptoms Due To Hay Fever Or Other Upper Respiratory Allergies Runny Nose Sneezing Itchy Watery Eyes Itching Of The Nose Or Throat
Pill Appearance
Color: yellow

Identifiers & Packaging

Container Type BOTTLE
UNII
7AJO3BO7QN
Packaging

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton NDC 49035-538-09 equate ™ Compare to Children's Claritin® active ingredient* children*s ALLERGY Loratadine Oral Solution USP, 5mg/5mL Antihistamine Non-Drowsy † 24 HOURS Sugar-Free Dye-Free AGES 2 YEARS AND OLDER 24 Hour Relief of: Sneezing Runny nose Itchy, watery eyes Itchy throat or nose Indoor & Outdoor Allergies Bubble Gum Flavor 4 FL OZ (120mL) Dosing Cup Enclosed † When taken as directed. See Drug Facts Panel. PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton NDC 49035-538-09 equate ™ Compare to Children's Claritin® active ingredient* children*s ALLERGY Loratadine Oral Solution USP, 5mg/5mL Antihistamine Non-Drowsy † 24 HOURS Sugar-Free Dye-Free AGES 2 YEARS AND OLDER 24 Hour Relief of: Sneezing Runny nose Itchy, watery eyes Itchy throat or nose Indoor & Outdoor Allergies Bubble Gum Flavor 4 FL OZ (120mL) Dosing Cup Enclosed † When taken as directed. See Drug Facts Panel. PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

Overview

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Indications & Usage

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat

Dosage & Administration

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

Warnings & Precautions
Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. 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. If pregnant or breast-feeding, ask a health professional before use. 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)
Purpose

Purpose Antihistamine

Do Not Use

Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

When Using

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

Stop Use & Ask a Doctor

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. (1-800-222-1222)

Storage & Handling

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

Questions

Questions? 1-888-287-1915


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