Children's Loratadine Oral Solution

Drug Labeling and Warnings

Drug Details [pdf]

LORATADINE- loratadine solution 
Preferred Pharmaceuticals, Inc.

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Children's Loratadine Oral Solution

Loratadine Oral Solution - Allergy

Active Ingredient: Loratadine 5 mg (in each 5 mL(teaspoonful)(TSP))

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 allergic reaction to this product or any of it's 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 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

  • Each teaspoonful contains: sodium 1 mg
  • Safety Sealed. Do not use if imprinted seal around cap is broken or missing
  • Store between 20° to 25°C (68° to 77°F)

Inactive ingredients

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

Questions

1-800-616-2471

Distributed by:
Major Pharmaceuticals
31778 Enterprise Drive,
Livonia, MI 48150 USA

Relabeled By: Preferred Pharmaceuticals Inc.

Loratadine Oral Solution 5mg/5mL
LORATADINE 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 68788-9805(NDC: 0904-6234)
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)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (grape flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 68788-9805-1120 mL in 1 CARTON; Type 0: Not a Combination Product05/09/201210/22/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07742105/09/201210/22/2019
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-9805)

Revised: 10/2019