CHILDRENS LORATADINE  SUGAR FREE- loratadine solution 
Major Pharmaceuticals

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Children's Loratadine Oral Solution
Sugar Free

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Loratadine 5 mg

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 an allergic reaction to this product or any of its 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. (1-800-222-1222)

Directions

  • use only with enclosed dosing cup
adults and children 6 years and over2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours
children 2 to under 6 years of age1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor

Other information

  • do not use if bottle wrap imprinted with "SEALED FOR SAFETY" is broken or missing.
  • see bottom panel for lot number and expiration date
  • store between 20° and 25°C (68° and 77°F)

Inactive ingredients

butylated hydroxyanisole, glycerin, grape flavor, maltitol solution, masking agent, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium phosphate monobasic dihydrate, sorbitol solution, sucralose powder.

Questions?

Call 1-866-923-4914

Distributed by:
MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

NDC 0904-6632-20

Compare to the
active ingredient
in Children's Claritin®*

MAJOR®

Original
Prescription Strength

Children's
Loratadine
Oral Solution
USP, 5 mg/5 mL

(Antihistamine)
ALLERGY

Non-Drowsy†

Indoor & Outdoor Allergies

SUGAR FREE

Dye Free

24
Hour

Relief of:

  • Sneezing
  • Runny Nose
  • Itchy, Watery Eyes
  • Itchy Throat or Nose

Ages 2 years
and older

Dosing Cup
Enclosed

Grape
Flavor

†When taken as directed.
See Drug Facts Panel.

4 FL OZ
(120 mL)

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
CHILDRENS LORATADINE   SUGAR FREE
loratadine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6632
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
butylated hydroxyanisole (UNII: REK4960K2U)  
glycerin (UNII: PDC6A3C0OX)  
sorbitol (UNII: 506T60A25R)  
polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A)  
phosphoric acid (UNII: E4GA8884NN)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956)  
Product Characteristics
ColorYELLOW (colorless to slightly yellow) Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6632-201 in 1 CARTON03/17/201705/21/2022
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07680503/17/201705/21/2022
Labeler - Major Pharmaceuticals (191427277)

Revised: 12/2022
Document Id: ca1cd0ff-7e21-489f-8e6b-fa1119088e1c
Set id: 86483f32-9b94-46de-9851-3278812c7bf7
Version: 2
Effective Time: 20221230
 
Major Pharmaceuticals