Label: CHILDRENS LORATADINE SUGAR FREE- loratadine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-131-08 - Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 24, 2018
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL teaspoonful)
- Purpose
- Uses
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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.
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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
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PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
TopCare®
health™NDC 36800-131-08
COMPARE TO
CHILDREN'S CLARITIN®
ACTIVE INGREDIENT*ORIGINAL
PRESCRIPTION STRENGTHchildren's
AllergyLORATADINE
ORAL SOLUTION USP
5 mg/ 5 mL
(ANTIHISTAMINE) / ALLERGY• OUR PHARMACISTS
RECOMMEND •INDOOR & OUTDOOR ALLERGIES
24
HOURRELIEF OF:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Sugar Free
& Dye FreeALCOHOL FREE
NON-DROWSY†Dosing Cup
EnclosedAges
2 Years
and olderGRAPE
FLAVOR4 FL OZ (120 mL)
†When taken as directed.
See Drug Facts Panel. -
INGREDIENTS AND APPEARANCE
CHILDRENS LORATADINE SUGAR FREE
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-131 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) 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 Color YELLOW (colorless to slightly yellow) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-131-08 1 in 1 CARTON 03/17/2017 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 ANDA076805 03/17/2017 Labeler - Topco Associates LLC (006935977)