Label: PICNIC ANTIHISTAMINE- loratadine tablet
- NDC Code(s): 80159-103-01, 80159-103-03
- Packager: 30M One, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 26, 2021
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- 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?
-
Principal Display Panel
LORATADINE TABLETS 10 mg
Antihistamine
Compare to the active ingredient in Claritin®
Original Prescription Strength / Non-Drowsy when taken as directed, see Drug Facts Panel
Indoor & Outdoor Allergies / 24 Hour Relief of: Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose / 100 Tablets for 100 Days of Relief
Actual Size
100 TABLETS
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INGREDIENTS AND APPEARANCE
PICNIC ANTIHISTAMINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80159-103 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:80159-103-01 30 in 1 CARTON 01/19/2021 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:80159-103-03 1 in 1 CARTON 01/19/2021 2 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076301 01/19/2021 Labeler - 30M One, Inc. (117621005)