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NDC 36800-0612-87 TopCare Allergy Relief 10 mg/1 Details
TopCare Allergy Relief 10 mg/1
TopCare Allergy Relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates 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: 36800-0612-87Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
| NDC | 36800-0612 |
|---|---|
| Product ID | 36800-612_0d420212-edb1-43f2-aad3-c82b82227310 |
| 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 | TopCare Allergy Relief |
| Proprietary Name Suffix | 24 hour |
| 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 | Topco Associates LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076301 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 36800-0612-87 (36800061287)
| NDC Package Code | 36800-612-87 |
|---|---|
| Billing NDC | 36800061287 |
| Package | 1 BOTTLE in 1 CARTON (36800-612-87) / 300 TABLET in 1 BOTTLE |
| Marketing Start Date | 2009-12-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a500aebf-a020-4da9-afdb-a699077cb8e1 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
Principal Display Panel
COMPARE TO CLARITIN® TABLETS ACTIVE INGREDIENT
NON-DROWSY*
ORIGINAL PRESCRIPTION STRENGTH
Allergy Relief
LORATADINE TABLETS, 10 mg ● ANTIHISTAMINE
INDOOR & OUTDOOR ALLERGIES
24 HOUR
RELIEF OF:
● Sneezing
● Runny Nose
● Itchy, Watery Eyes
● Itchy Throat or Nose
10 TABLETS
*When taken as directed. See Drug Facts Panel.
actual size
INGREDIENTS AND APPEARANCE
| TOPCARE ALLERGY RELIEF
24 HOUR
loratadine tablet |
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| Labeler - Topco Associates LLC (006935977) |