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NDC 49035-0061-08 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 Wal-Mart Stores 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: 49035-0061-08Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
| NDC | 49035-0061 |
|---|---|
| Product ID | 49035-061_fdf600f7-5fc6-4fa2-8d40-29b38db62e02 |
| 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 | Sugar Free |
| 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 | Wal-Mart Stores 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 49035-0061-08 (49035006108)
| NDC Package Code | 49035-061-08 |
|---|---|
| Billing NDC | 49035006108 |
| Package | 1 BOTTLE in 1 CARTON (49035-061-08) / 60 mL in 1 BOTTLE |
| Marketing Start Date | 2017-03-17 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8e504e0d-bfae-4c66-85a2-2fd7debb033a 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 49035-061-08
equate™
Compare
to Children's
Claritin®
Active
Ingredient*
Sugar Free
Ages 2 years and older
Children's
Allergy
Loratadine Oral Solution USP,
5mg/5mL (Antihistamine) Allergy
24 Hour Non-Drowsy**
Relieves:
- Sneezing
- Runny nose
- Itchy, watery eyes
- Itchy throat or nose
Original
Prescription
Strength
Dosage cup
enclosed
Indoor and
Outdoor Allergies
Dye Free Grape Flavor
4 FL OZ (120mL)
**When taken as directed
See Drug Facts Panel
INGREDIENTS AND APPEARANCE
| CHILDRENS LORATADINE
SUGAR FREE
loratadine solution |
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| Labeler - Wal-Mart Stores Inc (051957769) |