CHILDRENS LORATADINE- loratadine solution 
Pharmaceutical Associates, Inc.

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Children's Loratadine Oral Solution

Drug Facts

Active ingredient (in each 5 mL (teaspoonful) (TSP))

Loratadine 5 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

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.

Directions

adults and children 6 years and older2 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

Children's Loratadine Oral Solution is a clear, grape flavored solution supplied in the following oral dosage form:

NDC 0121-0849-10:10 mL unit dose cup.
NDC 0121-0849-40:Case contains 40 unit dose cups of 10 mL (0121-0849-10) packaged in 4 trays of 10 unit dose cups each.

Inactive ingredients

Butylated hydroxyanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.

Questions

Call 1-800-845-8210

MANUFACTURED BY
Silarx Pharmaceuticals, Inc.
1033 Stoneleigh Ave
Carmel, NY 10512

PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label

NDC 0121-0849-10

Children's Loratadine
Oral Solution

Dye Free/ Alcohol Free/ Sugar Free

10 mg/ 10 mL

USUAL DOSAGE: See attached Drug Facts

This unit-dose package is not child-resistant.

Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].

10 x 10 mL Unit-Dose Cups

Pharmaceutical
Associates, Inc.

Greenville, SC 29605

T0849100218
R02/18

Principal Display Panel - 10 mL Cup Tray Label
CHILDRENS LORATADINE 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0849(NDC:54838-554)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (grape flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0121-0849-404 in 1 CASE05/28/2018
110 in 1 TRAY
1NDC:0121-0849-1010 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07742111/24/2010
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaceutical Associates, Inc.097630693repack(0121-0849)
Establishment
NameAddressID/FEIBusiness Operations
Lannett Company, Inc.161630033label(0121-0849)

Revised: 5/2018
Document Id: 6ce530a9-4d87-6f4a-e053-2a91aa0a96e5
Set id: 64112220-8b9b-4871-9d6e-67ee1677acab
Version: 2
Effective Time: 20180523
 
Pharmaceutical Associates, Inc.