Label: ALLERGY RELIEF- loratadine tablet
- NDC Code(s): 80136-658-06
- Packager: NORTHEAST PHARMA
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated July 23, 2024
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
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.
- Directions
- Other information
- Inactive ingredients
- package label
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80136-658 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 SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) Product Characteristics Color white Score no score Shape ROUND Size 6mm Flavor Imprint Code 439 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80136-658-06 60 in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075209 02/01/2024 Labeler - NORTHEAST PHARMA (081232935) Registrant - Geri-Care Pharmaceutical Corp (611196254)