Label: LORATADINE ODT- loratadine tablet, orally disintegrating
- NDC Code(s): 46122-539-52, 46122-539-65
- Packager: Amerisource Bergen
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 10, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
- Do not use
- 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, Blister Carton 10 Orally Disintegrating Tablets
GOOD NEIGHBOR PHARMACY®
Compare to Claritin® RediTabs® active ingredient**
NDC 46122-539-52
Original Prescription Strength
Non-Drowsy*
24 HR
Loratadine Orally Disintegrating
Tablets USP 10 mg
Antihistamine
No Water Needed
Melts in Your Mouth
Indoor & Outdoor Allergies
Relief of:- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
*When taken as directed. See Drug Facts Panel.
actual size
10 Orally Disintegrating Tablets
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INGREDIENTS AND APPEARANCE
LORATADINE ODT
loratadine tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-539 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 ASPARTAME (UNII: Z0H242BBR1) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) MANNITOL (UNII: 3OWL53L36A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) PEPPERMINT (UNII: V95R5KMY2B) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI) Product Characteristics Color WHITE (White to Off-white) Score no score Shape ROUND (Biconvex) Size 8mm Flavor PEPPERMINT Imprint Code K;9 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-539-52 1 in 1 CARTON 07/09/2018 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:46122-539-65 3 in 1 CARTON 08/10/2022 2 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 ANDA208477 07/09/2018 Labeler - Amerisource Bergen (007914906) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650381903 ANALYSIS(46122-539) , MANUFACTURE(46122-539)