SPL UNCLASSIFIED SECTION.


Drug Facts.

DOSAGE & ADMINISTRATION SECTION.


Directions. adults and children years and older2 teaspoonfuls (TSP) daily; do not take more than teaspoonfuls (TSP) in 24 hourschildren to under years of age1 teaspoonful (TSP) daily; do not take more than teaspoonful (TSP) in 24 hourschildren under years of ageask doctorconsumers with liver or kidney diseaseask doctor.

INACTIVE INGREDIENT SECTION.


Inactive ingredients. Butylated hydroxyanisole, citric acid, glycerin, grape flavor, propylene glycol, purified water, sodium benzoate, sucralose.

INDICATIONS & USAGE SECTION.


Uses. temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:runny noseitchy, watery eyessneezingitching of the nose or throat. runny nose. itchy, watery eyes. sneezing. itching of the nose or throat.

OTC - ACTIVE INGREDIENT SECTION.


Active ingredient (in each mL (teaspoonful) (TSP)). Loratadine mg.

OTC - ASK DOCTOR SECTION.


Ask doctor before use if you have liver or kidney disease. Your doctor should determine if you need different dose.

OTC - DO NOT USE SECTION.


Do not use if you have ever had an allergic reaction to this product or any of its ingredients.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION.


If pregnant or breast-feeding, ask health professional before use.

OTC - PURPOSE SECTION.


Purpose. Antihistamine.

OTC - QUESTIONS SECTION.


Questions. Call 1-800-845-8210.

OTC - STOP USE SECTION.


Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away.

OTC - WHEN USING SECTION.


When using this product do not take more than directed. Taking more than directed may cause drowsiness.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 10 mL Cup Tray Label. NDC 0121-0849-10Childrens Loratadine Oral Solution Dye Free/ Alcohol Free/ Sugar Free10 mg/ 10 mLUSUAL DOSAGE: See attached Drug Facts This unit-dose package is not child-resistant.Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature]. 10 10 mL Unit-Dose CupsPharmaceutical Associates, Inc. Greenville, SC 29605 T0849100218 R02/18 Principal Display Panel 10 mL Cup Tray Label.

STORAGE AND HANDLING SECTION.


Other information. Each teaspoonful (TSP) contains: sodium mg Store between 20 to 25C (68 to 77F)Childrens Loratadine Oral Solution is clear, grape flavored solution supplied in the following oral dosage form:NDC 0121-0849-10:10 mL unit dose cup.NDC 0121-0849-40:Case contains 40 unit dose cups of 10 mL (0121-0849-10) packaged in trays of 10 unit dose cups each.. Each teaspoonful (TSP) contains: sodium mg Store between 20 to 25C (68 to 77F).

WARNINGS SECTION.


Warnings. Do not use if you have ever had an allergic reaction to this product or any of its ingredients Ask doctor before use if you have liver or kidney disease. Your doctor should determine if you need different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact Poison Control Center right away.