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NDC 70000-0125-01 Loratadine 5 mg/5mL Details
Loratadine 5 mg/5mL
Loratadine is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health, 110 dba LEADER. 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: 70000-0125-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
NDC | 70000-0125 |
---|---|
Product ID | 70000-0125_88e1fe57-4ad1-4646-b639-e935285aec4b |
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 | 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 | Cardinal Health, 110 dba LEADER |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA076805 |
Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 70000-0125-01 (70000012501)
NDC Package Code | 70000-0125-1 |
---|---|
Billing NDC | 70000012501 |
Package | 1 BOTTLE in 1 CARTON (70000-0125-1) / 118 mL in 1 BOTTLE |
Marketing Start Date | 2016-10-24 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.04364 |
Pricing Unit | ML |
Effective Date | 2022-07-20 |
NDC Description | CHILD ALLERGY 5 MG/5 ML SOLN |
Pharmacy Type Indicator | C/I |
OTC | Y |
Explanation Code | 4, 5 |
Classification for Rate Setting | G |
As of Date | 2022-11-23 |
Standard Product Labeling (SPL)/Prescribing Information SPL db9d2182-6bf1-424a-a144-f2694c47989f 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 - 118 mL Bottle Carton
LEADER™
Non-Drowsy†
Children's
Allergy
Loratadine Oral Solution
USP, 5 mg/5 mL
Antihistamine Allergy
Indoor & Outdoor Allergies
Fruit Flavor
Dye Free
24 Hour
Relief of:
- Sneezing
- Runny Nose
- Itchy Watery Eyes
- Itchy Throat or Nose
Ages 2 Years
and Older
COMPARE TO
CHILDREN'S
CLARITIN®
active ingredient*
100% Money
Back Guarantee
†When taken as directed. See Drug Facts Panel.
WARNING: Contains sodium metabisulfite, a sulfite that
may cause allergic-type reactions.
4 FL OZ (118 mL)
INGREDIENTS AND APPEARANCE
LORATADINE
loratadine solution |
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Labeler - Cardinal Health, 110 dba LEADER (063997360) |
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) |