Label: LORATADINE tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 21695-499-15, 21695-499-20, 21695-499-30, 21695-499-72, view more21695-499-90 - Packager: Rebel Distributors Corp
- This is a repackaged label.
- Source NDC Code(s): 51660-526
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated February 9, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Ask a doctor before use if you have
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
- Directions
- Other Information
- Inactive ingredients
- Questions?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21695-499(NDC:51660-526) 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 STARCH, CORN (UNII: O8232NY3SJ) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color WHITE Score no score Shape ROUND Size 7mm Flavor Imprint Code RX;526 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21695-499-15 15 in 1 BOTTLE 2 NDC:21695-499-20 20 in 1 BOTTLE 3 NDC:21695-499-30 30 in 1 BOTTLE 4 NDC:21695-499-90 90 in 1 BOTTLE 5 NDC:21695-499-72 120 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 01/21/2010 Labeler - Rebel Distributors Corp (118802834) Establishment Name Address ID/FEI Business Operations Rebel Distributors Corp 118802834 RELABEL, REPACK