Label: ALLERGY RELIEF- loratadine capsule, liquid filled
- NDC Code(s): 53943-116-13
- Packager: DISCOUNT DRUG MART, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated December 30, 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 capsule)
- 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
- Other information
- Inactive ingredients
- Questions or comments?
-
SPL UNCLASSIFIED SECTION
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPEN, OR IF FOIL INNER SEAL ON BOTTLE IS BROKEN
KEEP THIS CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
†This product is not manufactured or distributed by the owners of Claritin® LIQUI-GELS ®.
Distributed by: Discount Drug Mart
211 Commerce Drive, Medina, Ohio 44256
www.discount-drugmart.comSATISFACTION GUARANTEED
IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE
TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO
STORE, SEND REASON FOR DISSATISFACTION, NAME,
ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG
MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256R0721
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Principal Display Panel
DISCOUNT
drug
mart
FOOD MARKET
AN EMPLOYEE OWNERSHIP COMPANY
Non-Drowsy*
NDC 53943-116-13
24 Hour
Allergy Relief
Loratadine Capsules, 10 mg
Antihistamine
Indoor & Outdoor Allergies
24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose
†Compare to the active ingredient in Claritin ® LIQUI-GELS ®
30
SOFTGELS**
(**Liquid-Filled Capsules)
*When taken as directed. See Drug Facts Panel.
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INGREDIENTS AND APPEARANCE
ALLERGY RELIEF
loratadine capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-116 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 CAPRYLIC/CAPRIC MONO/DI-GLYCERIDES (UNII: U72Q2I8C85) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) HYPROMELLOSES (UNII: 3NXW29V3WO) HYDROLYSED BOVINE COLLAGEN (ENZYMATIC; 2000-5000 MW) (UNII: 5WE8P977RQ) ISOPROPYL ALCOHOL (UNII: ND2M416302) MANNITOL (UNII: 3OWL53L36A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL Size 10mm Flavor Imprint Code L10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53943-116-13 1 in 1 CARTON 08/20/2021 1 30 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 ANDA202538 08/20/2021 Labeler - DISCOUNT DRUG MART, INC. (047741335) Registrant - Bionpharma Inc. (079637826) Establishment Name Address ID/FEI Business Operations Patheon Softgels Inc. 002193829 manufacture(53943-116)