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Childrens Loratadine Sugar Free

Medically reviewed on September 18, 2017

Dosage form: solution
Ingredients: Loratadine 5mg in 5mL
Labeler: American Sales Company
NDC Code: 41520-131

Children's Loratadine Oral Solution
Sugar Free

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

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.

Questions?

Call 1-866-923-4914

DISTRIBUTED BY
FOODHOLD U.S.A., LLC
LANDOVER, MD 20785

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 41520-131-08

Compare to the
Active Ingredient
in Children's
Claritin®*

CAREONE®

24 HOUR/NON-DROWSY
SUGAR FREE

CHILDREN'S
ALLERGY
   Loratadine
Oral Solution USP, 5 mg/5 mL
(Antihistamine)   ALLERGY

Indoor & Outdoor Allergies

DYE FREE

GRAPE FLAVOR Ages 2 years and older

Relief of:
Sneezing, Runny Nose,
Itchy, Watery Eyes,
Itchy Throat or Nose

4 FL OZ
(120 mL)

† When taken as directed.
See Drug Facts Panel.

CHILDRENS LORATADINE   SUGAR FREE
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-131
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (Loratadine) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
butylated hydroxyanisole 
glycerin 
sorbitol 
polyethylene glycol, unspecified 
phosphoric acid 
propylene glycol 
water 
sodium benzoate 
Sodium Phosphate, Monobasic, Dihydrate 
Product Characteristics
ColorYELLOW (Colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-131-081 BOTTLE in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680503/17/2017
Labeler - American Sales Company (809183973)

 
American Sales Company

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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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