Label: LORATADINE ANTIHISTAMINE- loratadine tablet
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NDC Code(s):
63187-601-10,
63187-601-14,
63187-601-30,
63187-601-60, view more63187-601-90
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 45802-650
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 1, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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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
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Compare to Claritin® active ingredient
Loratadine Tablets, 10 mg
Antihistamine
24 Hour Relief of:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Throat or Nose
Original Prescription Strength
Non-Drowsy*
*When taken as directed.
See Drug Facts Panel.
Convenient Bottle
Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
actual size
60 TABLETS
Indoor & Outdoor Allergies
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INGREDIENTS AND APPEARANCE
LORATADINE ANTIHISTAMINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-601(NDC:45802-650) 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) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) Product Characteristics Color WHITE Score no score Shape OVAL Size 8mm Flavor Imprint Code L612 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-601-10 10 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2017 2 NDC:63187-601-14 14 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2017 3 NDC:63187-601-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2017 4 NDC:63187-601-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2017 5 NDC:63187-601-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 08/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 10/15/2008 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(63187-601) , RELABEL(63187-601)