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Childrens Loratadine by Taro Pharmaceuticals U.S.A., Inc.

Medically reviewed on January 8, 2018

Dosage form: solution
Ingredients: Loratadine 5mg in 5mL
Labeler: Taro Pharmaceuticals U.S.A., Inc.
NDC Code: 51672-2092

Children's Loratadine

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 mg

Purpose

Antihistamine

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

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)

Directions
  • use only with enclosed dosing cup
adults and children 6 years and over2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

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

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

Questions?

Call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 51672-2092-8

Compare to the
active ingredient
in Children's Claritin®*

Original
Prescription
Strength

Children's
Loratadine
Oral Solution
USP, 5 mg/5 mL

(Antihistamine)
ALLERGY
Non-Drowsy

24 Hour
Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Indoor & Outdoor Allergies
Ages 2 years and older

WARNING: Contains sodium metabisulfite,
a sulfite that may cause allergic-type reactions.

Dye Free
Sugar Free
Grape
Flavor

Dosage Cup
Enclosed

When taken as directed.
See Drug Facts Panel.

4 FL OZ
(120 mL)

CHILDRENS LORATADINE 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2092
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (Loratadine) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
glycerin 
sorbitol 
phosphoric acid 
polyethylene glycols 
propylene glycol 
water 
sodium benzoate 
sodium metabisulfite 
sodium phosphate, monobasic, dihydrate 
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51672-2092-41 BOTTLE in 1 CARTON
160 mL in 1 BOTTLE
2NDC:51672-2092-81 BOTTLE in 1 CARTON
2120 mL in 1 BOTTLE
3NDC:51672-2092-11 BOTTLE in 1 CARTON
3240 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680502/27/2010
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIOperations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2092)
Establishment
NameAddressID/FEIOperations
Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(51672-2092)

 
Taro Pharmaceuticals U.S.A., Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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