Your browser does not support JavaScript! LORATADINE SOLUTION [MAJOR PHARMACEUTICALS, INC]
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RxNorm Names

LORATADINE solution
[Major Pharmaceuticals, Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

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


Carton Label

LORATADINE 
loratadine solution
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6234-20120 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07742102/17/2011
Labeler - Major Pharmaceuticals, Inc (191427277)

Revised: 12/2013
 
Major Pharmaceuticals, Inc

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