Label: TOPCARE CHILDRENS ALLERGY- loratadine solution
- NDC Code(s): 36800-608-26
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 28, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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 or comments?
-
Package/Label Principal Display Panel
TopCare® health
COMPARE TO CHILDREN’S CLARITIN® ACTIVE INGREDIENT
children’s Allergy
LORATADINE ORAL SUSPENSION USP, 5 mg/5mL (ANTIHISTAMINE) / ALLERGY
INDOOR & OUTDOOR ALLERGIES
24 HOUR
24 HOUR RELIEF OF:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
Sugar Free & Dye Free
ALCOHOL FREE
NON-DROWSY†
Dosing Cup Enclosed
Ages 2 Years and older
GRAPE FLAVOR
4 FL OZ (120 mL)
†When taken as directed. See Drug Facts Panel.
-
INGREDIENTS AND APPEARANCE
TOPCARE CHILDRENS ALLERGY
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-608 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 EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW) PHOSPHORIC ACID (UNII: E4GA8884NN) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-608-26 1 in 1 CARTON 07/08/2020 1 120 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 ANDA075728 07/08/2020 Labeler - Topco Associates LLC (006935977)