Label: PREMIER VALUE CHILDRENS LORATADINE- loratadine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-164-01 - Packager: Chain Drug Constortium
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 21, 2014
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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
NDC 68016-164-01
COMPARE TO THE
ACTIVE INGREDIENT IN
CHILDREN'S CLARITIN®*Premier
ValueAges
two years
and olderChildren's
Loratadine
Oral Solution
5 mg/5 mL
AntihistamineSUGAR FREE
GRAPE flavorNon-Drowsy†
24 hour Allergy
Relief of: Sneezing;
Runny Nose; Itchy, Watery Eyes;
Itchy Throat or NoseINDOOR & OUTDOOR
ALLERGIES†When taken as directed.
See Drug Facts Panel.INDEPENDENTLY TESTED
P
V
SATISFACTION GUARANTEED4 FL OZ
(120 mL) -
INGREDIENTS AND APPEARANCE
PREMIER VALUE CHILDRENS LORATADINE
loratadine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-164 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 glycerin (UNII: PDC6A3C0OX) sorbitol (UNII: 506T60A25R) phosphoric acid (UNII: E4GA8884NN) polyethylene glycols (UNII: 3WJQ0SDW1A) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sodium metabisulfite (UNII: 4VON5FNS3C) 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:68016-164-01 1 in 1 CARTON 1 120 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076805 02/27/2010 Labeler - Chain Drug Constortium (101668460) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(68016-164) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(68016-164)