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NDC 49348-0636-34 Sunmark 5 mg/5mL Details
Sunmark 5 mg/5mL
Sunmark is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. 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: 49348-0636-34Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Loratadine
Product Information
NDC | 49348-0636 |
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Product ID | 49348-636_01e3d93a-0977-47a5-a983-f523681eb12f |
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 | Sunmark |
Proprietary Name Suffix | childrens loratadine |
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 | Strategic Sourcing Services LLC |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA076805 |
Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49348-0636-34 (49348063634)
NDC Package Code | 49348-636-34 |
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Billing NDC | 49348063634 |
Package | 1 BOTTLE in 1 CARTON (49348-636-34) / 120 mL in 1 BOTTLE |
Marketing Start Date | 2012-11-14 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 0.04249 |
Pricing Unit | ML |
Effective Date | 2024-02-21 |
NDC Description | SM LORATADINE 5 MG/5 ML SYRUP |
Pharmacy Type Indicator | C/I |
OTC | Y |
Explanation Code | 1, 5 |
Classification for Rate Setting | G |
As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL ed94cba7-c2c4-4cbe-9021-f554a51d51f2 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
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
sunmark®
COMPARE TO
CHILDREN'S CLARITIN®
ACTIVE INGREDIENT*
NDC 49348-636-34
24 HOUR
ALLERGY RELIEF
children's
loratadine
syrup
(Loratadine Oral Solution)
5 mg/5 mL Antihistamine
Relief of
sneezing, runny nose
itchy, watery eyes
itchy throat or nose
Dye Free
Non-drowsy†
Ages two years & older
FRUIT FLAVOR
4 FL OZ (120 mL)
†When taken as directed. See Drug Facts Panel.
INGREDIENTS AND APPEARANCE
SUNMARK
CHILDRENS LORATADINE
loratadine solution |
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Labeler - Strategic Sourcing Services LLC (116956644) |
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Taro Pharmaceutical Industries Ltd. | 600072078 | MANUFACTURE(49348-636) |