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NDC 58602-0423-24 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 Aurohealth LLC. 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: 58602-0423-24Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
| NDC | 58602-0423 |
|---|---|
| Product ID | 58602-423_3a36de14-2887-45e9-acc0-608fb1f73157 |
| 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 Oral |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/5mL |
| Substance Name | LORATADINE |
| Labeler Name | Aurohealth LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA208931 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 58602-0423-24 (58602042324)
| NDC Package Code | 58602-423-24 |
|---|---|
| Billing NDC | 58602042324 |
| Package | 1 BOTTLE in 1 CARTON (58602-423-24) / 120 mL in 1 BOTTLE |
| Marketing Start Date | 2018-06-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 0b86a9fe-db7e-470a-a8fa-d7d4373116ba Details
Uses
Warnings
Ask a doctor before use if you have
When using this product
Stop use and ask a doctor if
Keep out of reach of children.
Directions
- use only with enclosed dosing cup
| adults and children 6 years and over | 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours |
| children 2 to under 6 years of age | 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) in 24 hours |
| children under 2 years of age | ask a doctor |
| consumers with liver or kidney disease | ask a doctor |
Other information
Inactive ingredients
Questions or comments?
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle)
NDC 58602-423-11
Ages
2 years
and older
Loratadine
Oral Solution USP
5 mg/5 mL
Antihistamine
Non-Drowsy*
24 Hour Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Do not use if carton is opened,
or if cap safety seal is broken
or missing.
- Dye-Free
- Sugar-Free
- Alcohol Free
Indoor & Outdoor Allergies
Contains sodium metabisulfite,
a sulfite that may cause
allergic-type reactions.
* When taken as directed. See Drug Facts Panel.
Grape Flavor
2 FL OZ (60 mL)
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL)
NDC 58602-423-11
#Compare to the
active ingredient in
children’s Claritin®
Ages
2years
and older
Loratadine
Oral Solution USP
5 mg/5 mL
Antihistamine
Non-Drowsy*
24 Hour Relief of:
- Sneezing
- Runny Nose
- Itchy,watery Eyes
- Itchy Throat or Nose
Indoor & Outdoor Allergies
Dosing Cup Included
- Dye-Free
Contains sodium
metabisulfite, a sulfite
that may cause
allergic-type reactions.
* When taken as directed.
See Drug Facts Panel.
Grape
Flavor
2 FL OZ (60 mL)
INGREDIENTS AND APPEARANCE
| LORATADINE
loratadine oral solution |
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| Labeler - Aurohealth LLC (078728447) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Aurobindo Pharma Limited | 918917642 | ANALYSIS(58602-423) , MANUFACTURE(58602-423) | |