Label: CHILDRENS LORATADINE- loratadine solution
- NDC Code(s): 33261-908-01
- Packager: Aidarex Pharmaceuticals LLC
- This is a repackaged label.
- Source NDC Code(s): 51672-2085
- 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)
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
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Aidarex Pharmaceuticals, LLC.
Corona, CA 92880
- PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
Compare to the
Ages two years and older
5 mg/5 mL
Grape Flavored Syrup
Sneezing; Runny Nose,
Itchy, Watery Eyes,
Itchy Throat or Nose
4 FL OZ (120 mL)
† When taken as directed. See Drug Facts Panel.
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:33261-908(NDC:51672-2085) 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 CITRIC ACID MONOHYDRATE GLYCERIN PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM METABISULFITE SUCROSE 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:33261-908-01 5 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 - Aidarex Pharmaceuticals LLC (801503249)