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NDC 49035-0538-09 Childrens Allergy 5 mg/5mL Details
Childrens Allergy 5 mg/5mL
Childrens Allergy 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: 49035-0538-09Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
| NDC | 49035-0538 |
|---|---|
| Product ID | 49035-538_6ee5b7e9-711d-4d18-9cea-09a4d19d4332 |
| 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 | Childrens Allergy |
| 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 | Wal-Mart Stores Inc |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA201865 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49035-0538-09 (49035053809)
| NDC Package Code | 49035-538-09 |
|---|---|
| Billing NDC | 49035053809 |
| Package | 1 BOTTLE in 1 CARTON (49035-538-09) / 120 mL in 1 BOTTLE |
| Marketing Start Date | 2021-03-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9fb3a3a8-8812-4238-b596-291b79085db9 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 49035-538-09
equate™
Compare to
Children's
Claritin®
active
ingredient*
children*s
ALLERGY
Loratadine Oral
Solution USP,
5mg/5mL
Antihistamine
Non-Drowsy†
24
HOURS
Sugar-Free
Dye-Free
AGES 2 YEARS AND OLDER
24 Hour
Relief of:
- Sneezing
- Runny nose
- Itchy, watery eyes
- Itchy throat
or nose
Indoor & Outdoor
Allergies
Bubble Gum Flavor
4 FL OZ (120mL)
Dosing Cup
Enclosed
†When taken as directed. See Drug Facts Panel.
INGREDIENTS AND APPEARANCE
| CHILDRENS ALLERGY
loratadine solution |
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| Labeler - Wal-Mart Stores Inc (051957769) |