Loratadine by Major Pharmaceuticals, Inc LORATADINE solution

Loratadine by

Drug Labeling and Warnings

Loratadine by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Loratadine Oral Solution - Allergy

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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LORATADINE 
loratadine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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: 0904-6234-20	120 mL in 1 CARTON; Type 0: Not a Combination Product	02/17/2011	04/26/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA077421	02/17/2011	04/26/2020

Labeler - Major Pharmaceuticals, Inc (191427277)

Registrant - Major Pharmaceuticals, Inc (191427277)

Establishment
Name	Address	ID/FEI	Business Operations
Major Pharmaceuticals, Inc		191427277	REPACK(0904-6234)