Label: LORATADINE solution
- NDC Code(s): 0363-0771-01, 0363-0771-08
- Packager: WALGREEN COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 13, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL teaspoonful)
- Purpose
- Uses
-
Warnings
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.
-
Directions
- use only with enclosed dosing cup
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
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
NDC 0363-0771-08
Walgreens
Compare to the active ingredient
in Children's Claritin®††• WALGREENS •
PHARMACIST RECOMMENDED†Children's
Allergy
ReliefLORATADINE
ORAL SOLUTION USP 5mg/5mL
(ANTIHISTAMINE) ALLERGYDye Free
Sugar Free
24-Hour Relief
Non-Drowsy*- 24-hour relief of
runny nose; sneezing;
itchy throat or nose
& itchy, watery eyes - Indoor & outdoor
allergies
AGES
2
YEARS &
OLDER4 FL OZ (120 mL)
Bubble Gum
flavor - 24-hour relief of
-
INGREDIENTS AND APPEARANCE
LORATADINE
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0771 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 butylated hydroxyanisole (UNII: REK4960K2U) glycerin (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) sorbitol (UNII: 506T60A25R) phosphoric acid (UNII: E4GA8884NN) polyethylene glycol, unspecified (UNII: 3WJQ0SDW1A) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) sodium benzoate (UNII: OJ245FE5EU) sodium phosphate, monobasic, dihydrate (UNII: 5QWK665956) Product Characteristics Color YELLOW (colorless to slightly yellow) Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0771-08 1 in 1 CARTON 04/19/2023 1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:0363-0771-01 1 in 1 CARTON 04/19/2023 2 240 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA201865 04/19/2023 Labeler - WALGREEN COMPANY (008965063)