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TopCare Childrens Loratadine

Dosage form: solution
Ingredients: Loratadine 5mg in 5mL
Labeler: Topco Associates LLC
NDC Code: 36800-092

TopCare®
Children's Loratadine Syrup

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
  • safety sealed: do not use if imprinted safety seal is torn or missing
  • 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 1-888-423-0139

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

TopCare®

NDC 36800-092-08

ALCOHOL-FREE

Children's
Loratadine
Syrup

(LORATADINE ORAL SOLUTION)
5 mg/5 mL ANTIHISTAMINE

24 hour Non-Drowsy
Allergy Relief Sugar Free

Indoor & Outdoor Allergies
Ages two years and older

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

GRAPE
FLAVOR

QUALITY
GUARANTEED

COMPARE TO
CHILDREN'S
CLARITIN®
active ingredients*

4 FL OZ (120 mL)

When taken as directed. See Drug Facts Panel.

TOPCARE   CHILDRENS LORATADINE
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-092
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
FlavorGRAPE (sugar free) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-092-081 BOTTLE in 1 CARTON
1120 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680502/27/2010
Labeler - Topco Associates LLC (006935977)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIOperations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(36800-092)

 
Topco Associates LLC

Medically reviewed on Jun 12, 2018

Further information

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

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