Label: WAL-ITIN ALLERGY RELIEF- loratadine solution
- NDC Code(s): 0363-2085-01, 0363-2085-08
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated January 22, 2013
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL)
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.
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
adults and children
6 years and over
2 teaspoonfuls daily; do not take
more than 2 teaspoonfuls in 24 hours
children 2 to under
6 years of age
1 teaspoonful daily; do not take more
than 1 teaspoonful in 24 hours
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 2° and 25°C (36° and 77°F)
- Inactive ingredients
artificial grape flavor, citric acid monohydrate, glycerin, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sucroseClose
- SPL UNCLASSIFIED SECTION
Distributed by: Walgreen Co.,Close
200 Wilmot Rd., Deerfield, IL 60015-4616
- PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
Compare to Children's
Claritin†® active ingredient
Ages 2 Years
Loratadine Oral Solution,
- Sneezing • Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Original Prescription Strength
4 FL OZ (120 mL)
* When taken as directed. See Drug Facts Panel.
- INGREDIENTS AND APPEARANCE
WAL-ITIN ALLERGY RELIEF
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-2085 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 citric acid monohydrate (UNII: 2968PHW8QP) glycerin (UNII: PDC6A3C0OX) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) sodium benzoate (UNII: OJ245FE5EU) sodium metabisulfite (UNII: 4VON5FNS3C) sucrose (UNII: C151H8M554) 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:0363-2085-08 1 in 1 CARTON 1 120 mL in 1 BOTTLE 2 NDC:0363-2085-01 1 in 1 CARTON 2 240 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076805 08/20/2004 Labeler - Walgreen Company (008965063) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceutical Indutries Ltd. 600072078 MANUFACTURE(0363-2085)