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NDC 49483-0686-07 LORATADINE 10 mg/1 Details
LORATADINE 10 mg/1
LORATADINE is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by TIME CAP LABORATORIES INC. 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: 49483-0686-07Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
| NDC | 49483-0686 |
|---|---|
| Product ID | 49483-686_6c562c37-86ca-42c2-e053-2a91aa0a8a8a |
| Associated GPIs | 41550030000120 |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | LORATADINE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | LORATADINE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | LORATADINE |
| Labeler Name | TIME CAP LABORATORIES INC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206214 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49483-0686-07 (49483068607)
| NDC Package Code | 49483-686-07 |
|---|---|
| Billing NDC | 49483068607 |
| Package | 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (49483-686-07) |
| Marketing Start Date | 2016-10-13 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 85b26cf3-448c-4d4f-93a2-aa89530ec1f1 Details
SPL UNCLASSIFIED SECTION
DO NOT USE IF YOU HAVE EVER HAD AN ALLERGIC REACTION TO THIS PRODUCT OR ANY OF ITS INGREDIENTS.
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.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| LORATADINE
loratadine capsule, liquid filled |
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| Labeler - TIME CAP LABORATORIES INC (037052099) |
| Registrant - TIME CAP LABORATORIES INC (037052099) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| MARKSANS PHARMA LIMITED | 925822975 | manufacture(49483-686) | |