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NDC 11673-0111-30 DYE-FREE CHILDRENS LORATADINE 5 mg/1 Details
DYE-FREE CHILDRENS LORATADINE 5 mg/1
DYE-FREE CHILDRENS LORATADINE is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by UP & UP. 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: 11673-0111-30Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
| NDC | 11673-0111 |
|---|---|
| Product ID | 11673-111_b9e6809c-e0ce-4205-98c5-665af1716503 |
| Associated GPIs | |
| 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 | DYE-FREE 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 | UP & UP |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210088 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 11673-0111-30 (11673011130)
| NDC Package Code | 11673-111-30 |
|---|---|
| Billing NDC | 11673011130 |
| Package | 3 BLISTER PACK in 1 CARTON (11673-111-30) / 10 TABLET, CHEWABLE in 1 BLISTER PACK |
| Marketing Start Date | 2020-11-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9660f7e6-3a29-4a6d-ba57-92088f624aa4 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
- chew or crush tablets completely before swallowing.
| adults and children 6 years and over | chew 2 tablets daily; not more than 2 tablets in 24 hours |
| children 2 to under 6 years of age | chew 1 tablet daily; not more than 1 tablet 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
PRINCIPAL DISPLAY PANEL - 5 mg Tablet Blister Pack Carton
Compare to active ingredient in Children's
Claritin® Chewables*
NDC 11673-111-30
dye-free
children's
allergy
loratadine chewable tablets USP, 5 mg
antihistamine
non-drowsy**
indoor and outdoor allergies
24-hour relief of:
- sneezing
- runny nose
- itchy, watery eyes
- itchy throat or nose
**When taken as directed. See drug facts panel.
up & up
GRAPE
FLAVOR
ACTUAL SIZE
30
CHEWABLE
TABLETS
30 CHEWABLE TABLETS
THE CHEWABLE TABLETS ARE
TO BE CHEWED BEFORE SWALLOWING
INGREDIENTS AND APPEARANCE
| DYE-FREE CHILDRENS LORATADINE
loratadine tablet, chewable |
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| Labeler - UP & UP (006961700) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Ohm Laboratories Inc. | 184769029 | MANUFACTURE(11673-111) | |