Label: WESTERN FAMILY CHILDRENS ALLERGY RELIEF- loratadine solution
- NDC Code(s): 55312-092-08
- Packager: Western Family Foods Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated March 27, 2014
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL teaspoonful)
Loratadine 5 mgClose
temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- itchy, watery eyes
- itching of the nose or throat
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.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
- 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
- safety sealed: do not use if imprinted safety seal is torn or missing
- store between 20° and 25°C (68° and 77°F)
- Inactive ingredients
glycerin, grape flavor, maltitol solution, masking agent, noncrystallizing sorbitol solution, phosphoric acid, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sodium phosphate monobasic dihydrate, sucralose powder.Close
- SPL UNCLASSIFIED SECTION
Proudly Distributed byClose
Western Family Foods, Inc.
P.O. Box 4057, Portland, OR 97208 U.S.A.
- PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
INDOOR & OUTDOOR ALLERGIES
ORAL SOLUTION 5 mg / 5 mL
24 HOUR RELIEF OF:
✓ITCHY, WATERY EYES
✓ITCHY THROAT OR NOSE
†When taken as directed. See Drug Facts Panel.
4 FL OZ (120 mL)
COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S CLARITIN®*
- INGREDIENTS AND APPEARANCE
WESTERN FAMILY CHILDRENS ALLERGY RELIEF
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-092 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 (sugar free) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55312-092-08 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 - Western Family Foods Inc (192166072) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(55312-092)