LORATADINE- loratadine solution

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Atlantic Biologicals Corps. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

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

ever had allergic reaction to this product or any of it's ingredients Do not use if you have

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

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

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

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

. In case of overdose, get medical help or contact a Poison Control Center right away. Keep out of reach of children

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

• : sodium 1 mg Each teaspoonful contains
• 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

LORATADINE SOLUTION

INGREDIENTS AND APPEARANCE

LORATADINE  
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-6234(NDC:0904-6234)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Loratadine (UNII: 7AJO3BO7QN) (Loratadine - UNII:7AJO3BO7QN)	Loratadine	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	GRAPE (grape flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17856-6234-2	5 mL in 1 CUP; Type 0: Not a Combination Product	05/03/2016
2	NDC: 17856-6234-5	5 mL in 1 CUP; Type 0: Not a Combination Product	08/16/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077421	02/17/2011

Labeler - Atlantic Biologicals Corps (047437707)

Registrant - Atlantic Biologicals Corps (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
Atlantic Biologicals Corps		047437707	RELABEL(17856-6234) , REPACK(17856-6234)