Label: LORATADINE tablet
- NDC Code(s): 55154-4375-0
- Packager: Cardinal Health 107, LLC
- This is a repackaged label.
- Source NDC Code(s): 51079-246
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated January 23, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each tablet)
- Purpose
- Uses
-
Warnings
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.
- Directions (24 Hour Relief)
- Other information
- Inactive Ingredients
-
Questions or comments?
1-800-848-0462
- •
- Serious side effects associated with use of this product may be reported to this number.
Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.Made in India
Code No.: MH/DRUGS/25/NKD/89
Distributed by:
Mylan Institutional Inc.
Rockford, IL 61103 U.S.A.Distributed by:
Cardinal Health
Dublin, OH 43017
L49557610124
S-11333 R2
11/16 - Principal Display Panel
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INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55154-4375(NDC:51079-246) 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) Product Characteristics Color WHITE (white to off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code G;L;10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55154-4375-0 10 in 1 BAG 04/30/2013 08/31/2024 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076154 04/30/2013 08/31/2024 Labeler - Cardinal Health 107, LLC (118546603)