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NDC 37205-0378-26 Loratadine 5 mg/5mL Details
Loratadine 5 mg/5mL
Loratadine is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is LORATADINE.
MedlinePlus Drug Summary
Loratadine is used to temporarily relieve the symptoms of hay fever (allergy to pollen, dust, or other substances in the air) and other allergies. These symptoms include sneezing, runny nose, and itchy eyes, nose, or throat. Loratadine is also used to treat itching and redness caused by hives. However, loratadine does not prevent hives or other allergic skin reactions. Loratadine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Loratadine is also available in combination with pseudoephedrine (Sudafed, others). This monograph only includes information about the use of loratadine alone. If you are taking the loratadine and pseudoephedrine combination product, read the information on the package label or ask your doctor or pharmacist for more information.
Related Packages: 37205-0378-26Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
| NDC | 37205-0378 |
|---|---|
| Product ID | 37205-378_50612f6b-c83f-451b-a2c0-09d9a542718f |
| Associated GPIs | 41550030001220 |
| GCN Sequence Number | 018697 |
| GCN Sequence Number Description | loratadine SOLUTION 5 MG/5 ML ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 60562 |
| HICL Sequence Number | 007605 |
| HICL Sequence Number Description | LORATADINE |
| Brand/Generic | Generic |
| Proprietary Name | Loratadine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Loratadine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/5mL |
| Substance Name | LORATADINE |
| Labeler Name | Cardinal Health |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076805 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 37205-0378-26 (37205037826)
| NDC Package Code | 37205-378-26 |
|---|---|
| Billing NDC | 37205037826 |
| Package | 1 BOTTLE in 1 CARTON (37205-378-26) / 120 mL in 1 BOTTLE |
| Marketing Start Date | 2004-08-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 6f881bd5-14c4-4077-ad03-1fae2d6ccb3b Details
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
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
LEADER®
NDC 37205-378-26
Compare to
Children's Claritin®
active ingredient†
Original Prescription
Strength
NON-DROWSY*
Allergy
Relief
Loratadine Syrup
(Loratadine Oral Solution) 5 mg/5 mL
Antihistamine
24 Hour
Relief of: Sneezing, Runny Nose,
Itchy, Watery Eyes • Itchy Throat or Nose
Fruit Flavor
*When taken as directed.
See Drug Facts Panel.
Ages two years
and older
SATISFACTION
GUARANTEED
4 FL OZ (120 mL)
INGREDIENTS AND APPEARANCE
| LORATADINE
loratadine solution |
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| Labeler - Cardinal Health (097537435) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Taro Pharmaceutical Industries Ltd. | 600072078 | MANUFACTURE(37205-378) | |