Label: CHILDRENS WAL-ITIN- loratadine solution
- NDC Code(s): 0363-2092-01, 0363-2092-08
- Packager: Walgreen 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
DISTRIBUTED BY: WALGREEN CO.Close
200 WILMOT RD., DEERFIELD, IL 60015
- PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
WALGREENS PHARMACIST RECOMMENDED‡
Loratadine Oral Solution
5 mg/5 mL / Antihistamine
- Alcohol free
- Sugar free
- Relief of runny nose, sneezing,
itchy throat or nose & itchy,
- Ages 2 years & older
4 FL OZ (120 mL)
Compare to Children's Claritin®
*WHEN TAKEN AS DIRECTED. SEE DRUG FACTS PANEL.
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-2092 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (LORATADINE) LORATADINE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength GLYCERIN SORBITOL PHOSPHORIC ACID POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM METABISULFITE SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE 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:0363-2092-01 1 in 1 CARTON 1 240 mL in 1 BOTTLE 2 NDC:0363-2092-08 1 in 1 CARTON 2 120 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 - Walgreen Company (008965063) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(0363-2092) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(0363-2092)