Topcare childrens loratadine solution

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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

Otc - do not use section

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

Otc - ask doctor section

Ask a doctor before use if you haveliver or kidney disease. Your doctor should determine if you need a different dose.

Otc - when using section

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

Otc - stop use section

Stop use and ask a doctor ifan allergic reaction to this product occurs. Seek medical help right away.

Otc - pregnancy or breast feeding section

If pregnant or breast-feeding,ask a health professional before use.

Otc - keep out of reach of children section

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 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

Other information

  • safety sealed: do not use if imprinted safety seal is torn or missing
  • store between 20 and 25C (68 and 77F)

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

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DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

Ingredients and appearance - Product information

Topcare childrens loratadine solution- Loratadine

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 36800-092
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Loratadine ( UNII: 7AJO3BO7QN)( Loratadine - UNII: 7AJO3BO7QN ) 5 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Glycerin ( UNII: PDC6A3C0OX)
Sorbitol ( UNII: 506T60A25R)
Phosphoric acid ( UNII: E4GA8884NN)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sodium metabisulfite ( UNII: 4VON5FNS3C)
Sodium phosphate, monobasic, dihydrate ( UNII: 5QWK665956)

Product Characteristics

Color YELLOW (colorless to slightly yellow) Flavor GRAPE (sugar free)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA076805 USA

Labeler - Topco Associates LLC( 006935977)

Establishment

Name ID/FEI Business Operations
Topco Associates LLC 006935977 MANUFACTURE( 36800-092)

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.