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NDC 46122-0550-60 Childrens Loratadine 5 mg/1 Details
Childrens Loratadine 5 mg/1
Childrens Loratadine is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Amerisource Bergen. 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: 46122-0550-60Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
| NDC | 46122-0550 |
|---|---|
| Product ID | 46122-550_974fbe97-a712-4675-b438-afb924c92b28 |
| Associated GPIs | 41550030000520 |
| GCN Sequence Number | 062340 |
| GCN Sequence Number Description | loratadine TAB CHEW 5 MG ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 98118 |
| HICL Sequence Number | 007605 |
| HICL Sequence Number Description | LORATADINE |
| Brand/Generic | Generic |
| Proprietary Name | Childrens Loratadine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | LORATADINE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, CHEWABLE |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/1 |
| Substance Name | LORATADINE |
| Labeler Name | Amerisource Bergen |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210088 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 46122-0550-60 (46122055060)
| NDC Package Code | 46122-550-60 |
|---|---|
| Billing NDC | 46122055060 |
| Package | 2 BLISTER PACK in 1 CARTON (46122-550-60) / 10 TABLET, CHEWABLE in 1 BLISTER PACK |
| Marketing Start Date | 2018-07-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8ec562d3-9d4c-4e28-bc8e-f725079f603a 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 - 5 mg Tablet Blister Pack Carton
GOOD
NEIGHBOR
PHARMACY®
Compare to Children's Claritin®
Chewables active ingredient**
NDC 46122-550-60
ages 2 years and older
Non-Drowsy*
24 HOUR
Children's
loratadine chewable tablets USP, 5 mg
antihistamine
Indoor & Outdoor Allergies
Relief of:
• Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose
20 Chewable Tablets
The chewable tablets are to be chewed before swallowing.
*When taken as directed. See Drug Facts Panel.
actual size
grape flavor
INGREDIENTS AND APPEARANCE
| CHILDRENS LORATADINE
loratadine tablet, chewable |
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| Labeler - Amerisource Bergen (007914906) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ohm Laboratories Inc. | 184769029 | MANUFACTURE(46122-550) | |