Label: CLARITIN- loratadine tablet
- NDC Code(s): 67751-153-01
- Packager: Navajo Manufacturing Company Inc.
- This is a repackaged label.
- Source NDC Code(s): 11523-7160
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated November 4, 2019
If you are a consumer or patient please visit this version.
- Drug Facts
- Active ingredient (in each tablet)
Do not use if you have ever had an allergic reaction to this product or any of its ingredients.
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.
Stop use and ask a doctor if
an allergic reaction to this product occurs. Seek medical help right away.
- Other information
- Inactive ingredients
- Questions or comments?
- Package Labeling:
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67751-153(NDC:11523-7160) 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 STARCH, CORN (UNII: O8232NY3SJ) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND Size 6mm Flavor Imprint Code 458;Claritin10 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67751-153-01 1 in 1 CARTON 09/17/2016 1 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019658 09/17/2016 Labeler - Navajo Manufacturing Company Inc. (091917799) Establishment Name Address ID/FEI Business Operations Navajo Manufacturing Company Inc. 136941411 relabel(67751-153) , repack(67751-153)