Label: LIVE BETTER LORATADINE- loratadine solution
- NDC Code(s): 51143-092-08
- Packager: The Great Atlantic & Pacific Tea Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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
2 PARAGON DRIVE,
MONTVALE, NJ 07645
- PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
Compare to the active ingredient
in Children's Claritin®*
Original Prescription Strength
(Loratadine Oral Solution)
5 mg/5 mL Antihistamine
24 Hour Non-Drowsy†
- SUGAR FREE
- GRAPE FLAVORED SYRUP
- INDOOR & OUTDOOR
- RELIEF OF:
SNEEZING, RUNNY NOSE,
ITCHY, WATERY EYES,
ITCHY THROAT OR NOSE
- DOSAGE CUP ENCLOSED
- AGES TWO YEARS
†WHEN TAKEN AS DIRECTED.
SEE DRUG FACTS PANEL.
4 FL OZ (120 mL)
- INGREDIENTS AND APPEARANCE
LIVE BETTER LORATADINE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51143-092 Route of Administration ORAL DEA Schedule 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:51143-092-08 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 - The Great Atlantic & Pacific Tea Company (001367366) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51143-092)