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NDC 63187-0305-10 Loratadine and Pseudoephedrine 10; 240 mg/1; mg/1 Details
Loratadine and Pseudoephedrine 10; 240 mg/1; mg/1
Loratadine and Pseudoephedrine is a ORAL TABLET, EXTENDED RELEASE in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is LORATADINE; PSEUDOEPHEDRINE SULFATE.
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: 63187-0305-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Loratadine
Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.
Related Packages: 63187-0305-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pseudoephedrine
Product Information
| NDC | 63187-0305 |
|---|---|
| Product ID | 63187-305_4b42b2f4-a013-4b16-bc3e-d9c3b503beed |
| 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 | Loratadine and Pseudoephedrine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | loratadine and pseudoephedrine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 10; 240 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | LORATADINE; PSEUDOEPHEDRINE SULFATE |
| Labeler Name | Proficient Rx LP |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076557 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63187-0305-10 (63187030510)
| NDC Package Code | 63187-305-10 |
|---|---|
| Billing NDC | 63187030510 |
| Package | 1 BLISTER PACK in 1 CARTON (63187-305-10) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK |
| Marketing Start Date | 2015-03-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ca1a6552-d082-4312-ba17-0055e8554eb9 Details
USES
- •
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- •
- sneezing
- •
- itchy, watery eyes
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- runny nose
- •
- itching of the nose or throat
- •
- reduces swelling of nasal passages
- •
- temporarily relieves sinus congestion and pressure
- •
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- •
- temporarily restores freer breathing through the nose
WARNINGS
Do not use
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
- •
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- •
- heart disease
- •
- thyroid disease
- •
- high blood pressure
- •
- diabetes
- •
- trouble urinating due to an enlarged prostate gland
- •
- 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
Calcium carbonate, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium alginate, sodium citrate, talc and titanium dioxide
PRINCIPAL DISPLAY PANEL
†Compare to the active ingredients of Claritin-D® 24 Hour
ohm®
NDC 63187-305-10
NON-DROWSY*
24 Hour Allergy Relief
Original Prescription Strength
Allergy Relief & Nasal Decongestant
Loratadine, USP 10 mg/Antihistamine
Pseudoephedrine Sulfate, USP 240 mg/Nasal Decongestant
Indoor & Outdoor Allergies
Relief of:
- •
- Nasal & Sinus Congestion Due to Colds or Allergies
- •
- Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose Due to Allergies
Allergy & Congestion
5 Extended-Release Tablets
*When taken as directed. See Drug Facts Panel.
Distributed by: Ohm Laboratories Inc.
Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
5079399/R0610
5’s blister carton
INGREDIENTS AND APPEARANCE
| LORATADINE AND PSEUDOEPHEDRINE
loratadine and pseudoephedrine tablet, extended release |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | REPACK(63187-305) , RELABEL(63187-305) | |