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NDC 51672-2073-05 Childrens Loratadine 5 mg/5mL Details
Childrens Loratadine 5 mg/5mL
Childrens Loratadine is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Taro Pharmaceuticals U.S.A., 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: 51672-2073-05Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
| NDC | 51672-2073 |
|---|---|
| Product ID | 51672-2073_f19e5d03-5c87-46a1-bba0-25c67ab75662 |
| Associated GPIs | 41550030001220 |
| GCN Sequence Number | 018697 |
| GCN Sequence Number Description | loratadine SOLUTION 5 MG/5 ML ORAL |
| HIC3 | Z2Q |
| HIC3 Description | ANTIHISTAMINES - 2ND GENERATION |
| GCN | 60562 |
| 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 | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 5 |
| Active Ingredient Units | mg/5mL |
| Substance Name | LORATADINE |
| Labeler Name | Taro Pharmaceuticals U.S.A., Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076805 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51672-2073-05 (51672207305)
| NDC Package Code | 51672-2073-5 |
|---|---|
| Billing NDC | 51672207305 |
| Package | 1 BOTTLE in 1 CARTON (51672-2073-5) / 180 mL in 1 BOTTLE |
| Marketing Start Date | 2004-08-20 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d0 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
- use only with enclosed dosing cup
| adults and children 6 years and over | 2 teaspoonfuls (tsp) daily; do not take more than 2 teaspoonfuls (tsp) in 24 hours |
| children 2 to under 6 years of age | 1 teaspoonful (tsp) daily; do not take more than 1 teaspoonful (tsp) 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 - 120 mL Bottle Carton
NDC 51672-2073-8
Compare to the
active ingredient
in Children's Claritin®*
Original
Prescription
Strength
Children's
Loratadine
Oral Solution
USP, 5 mg/5 mL
(Antihistamine)
ALLERGY
Non-Drowsy†
24 Hour
Relief of:
- Sneezing
- Runny Nose
- Itchy, Watery Eyes
- Itchy Throat or Nose
Indoor & Outdoor Allergies
Ages 2 years and older
WARNING: Contains sodium metabisulfite,
a sulfite that may cause allergic-type reactions.
Dye Free
Fruit Flavor
Dosage Cup
Enclosed
†When taken as directed.
See Drug Facts Panel.
4 FL OZ
(120 mL)
INGREDIENTS AND APPEARANCE
| CHILDRENS LORATADINE
loratadine solution |
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| Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Taro Pharmaceutical Industries Ltd. | 600072078 | MANUFACTURE(51672-2073) | |