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NDC 61919-0142-07 LORATADINE 10 mg/1 Details
LORATADINE 10 mg/1
LORATADINE is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by DirectRx. 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: 61919-0142-07Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
| NDC | 61919-0142 |
|---|---|
| Product ID | 61919-142_e9d50898-d4cc-caeb-e053-2995a90a17bd |
| Associated GPIs | 41550030000320 |
| GCN Sequence Number | 018698 |
| GCN Sequence Number Description | loratadine TABLET 10 MG ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 60563 |
| 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 | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | LORATADINE |
| Labeler Name | DirectRx |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076301 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 61919-0142-07 (61919014207)
| NDC Package Code | 61919-142-07 |
|---|---|
| Billing NDC | 61919014207 |
| Package | 7 TABLET in 1 BOTTLE (61919-142-07) |
| Marketing Start Date | 2021-09-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cbe44cc5-d534-4d17-e053-2995a90a021c Details
SPL UNCLASSIFIED SECTION
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.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
adults and children 6 years and over
1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of age
ask a doctor
consumers with liver or kidney disease
ask a doctor
Other information
do not use if printed foil under cap is broken or missing
store at 20°-25°C (68°-77°F)
Questions or comments?
1-800-719-9260
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| LORATADINE
loratadine tablet |
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| Labeler - DirectRx (079254320) |
| Registrant - DirectRx (079254320) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| DirectRx | 079254320 | repack(61919-142) | |