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Loratadine by Major Pharmaceuticals, Inc

Dosage form: solution
Ingredients: Loratadine 5mg in 5mL
Labeler: Major Pharmaceuticals, Inc
NDC Code: 0904-6234

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

LORATADINE 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6234
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Loratadine (Loratadine) Loratadine5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
butylated hydroxyanisole 
glycerin 
propylene glycol 
sodium benzoate 
sucralose 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (grape flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-6234-20120 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07742102/17/201104/26/2020
Labeler - Major Pharmaceuticals, Inc (191427277)
Registrant - Major Pharmaceuticals, Inc (191427277)
Establishment
NameAddressID/FEIOperations
Major Pharmaceuticals, Inc191427277REPACK(0904-6234)

 
Major Pharmaceuticals, Inc

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Medically reviewed on Jul 25, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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