Label: LORATADINE tablet
- NDC Code(s): 68016-094-10, 68016-094-30, 68016-094-60, 68016-094-90
- Packager: Chain Drug Consortium, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 4, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet)
- 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 or comments?
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (60 Tablets Bottle)
#COMPARE TO THE ACTIVE
INGREDIENT IN CLARITIN®
Non-Drowsy*
Premier
Value®
Loratadine Tablets USP 10 mg
Allergy Relief
AntihistamineIndoor & Outdoor
Allergies
24 Hour Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
60 Tablets
*When taken as directed See Drug Facts Panel.
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Container Carton (60 Tablets)
#COMPARE TO THE ACTIVE
INGREDIENT IN CLARITIN®
Non-Drowsy*
Premier
Value®
Loratadine Tablets USP 10 mg
Allergy
Relief
Antihistamine
Indoor & Outdoor Allergies
24 Hours Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
60 Tablets
*When taken as directed
See Drug Facts Panel.
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (30 Tablets)
#COMPARE TO THE ACTIVE
INGREDIENT IN CLARITIN®
Non-Drowsy*
Premier
Value®
Loratadine Tablets USP 10 mg
Allergy Relief
Antihistamine
Indoor & Outdoor
Allergies
24 Hours Relief of:
• Sneezing
• Runny Nose
• Itchy, Watery Eyes
• Itchy Throat or Nose
10 Tablets
*When taken as directed See Drug Facts Panel.
-
INGREDIENTS AND APPEARANCE
LORATADINE
loratadine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-094 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) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color WHITE (White to Off-white) Score no score Shape ROUND Size 6mm Flavor Imprint Code 39;L Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-094-60 1 in 1 CARTON 04/16/2018 1 60 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:68016-094-90 1 in 1 CARTON 04/16/2018 2 90 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:68016-094-10 1 in 1 CARTON 04/16/2018 3 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 4 NDC:68016-094-30 3 in 1 CARTON 04/16/2018 4 10 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 ANDA208314 04/16/2018 Labeler - Chain Drug Consortium, LLC (101668460) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(68016-094) , MANUFACTURE(68016-094)