Label: ALLERGY RELIEF 10 MG- loratadine tablet
- NDC Code(s): 55681-303-03
- Packager: TWIN MED LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated March 9, 2022
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- Active ingredient (in each tablet)
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
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.
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ALLERGY RELIEF 10 MG
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55681-303 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 10 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) Product Characteristics Color white Score no score Shape ROUND Size 7mm Flavor Imprint Code G;10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55681-303-03 300 in 1 BOTTLE; Type 0: Not a Combination Product 03/02/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA210722 03/02/2022 Labeler - TWIN MED LLC (009579330)