Loratadine And Pseudoephedrine Sulfate
Strategic Sourcing Services Llc
Human Otc Drug
NDC 62011-0071Loratadine And Pseudoephedrine Sulfate is a human otc drug labeled by 'Strategic Sourcing Services Llc'. National Drug Code (NDC) number for Loratadine And Pseudoephedrine Sulfate is 62011-0071. This drug is available in dosage form of Tablet, Film Coated, Extended Release. The names of the active, medicinal ingredients in Loratadine And Pseudoephedrine Sulfate drug includes Loratadine - 10 mg/1 Pseudoephedrine Sulfate - 240 mg/1 . The currest status of Loratadine And Pseudoephedrine Sulfate drug is Active.
Drug Information:
| Drug NDC: | 62011-0071 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Loratadine And Pseudoephedrine Sulfate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Loratadine And Pseudoephedrine Sulfate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Strategic Sourcing Services Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated, Extended Release |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | LORATADINE - 10 mg/1
PSEUDOEPHEDRINE SULFATE - 240 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 06 Jun, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA076557 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Strategic Sourcing Services LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1117562
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0052569140390
|
| UPC stands for Universal Product Code. |
| UNII: | 7AJO3BO7QN
Y9DL7QPE6B
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Adrenergic alpha-Agonists [MoA]
alpha-Adrenergic Agonist [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 62011-0071-2 | 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62011-0071-2) | 06 Jun, 2017 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose antihistamine nasal decongestant
Product Elements:
Loratadine and pseudoephedrine sulfate loratadine and pseudoephedrine sulfate loratadine loratadine pseudoephedrine sulfate pseudoephedrine calcium carbonate hypromellose, unspecified ferrosoferric oxide lactose monohydrate magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified povidone, unspecified starch, corn propylene glycol shellac sodium alginate sodium citrate, unspecified form talc titanium dioxide silicon dioxide hydroxypropyl cellulose (1600000 wamw) white to off-white flat faced beveled edge rc17
Indications and Usage:
Uses ⢠temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: ⢠sneezing ⢠itchy, watery eyes ⢠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:
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. stop use and ask a doctor if ⢠an allergic reaction to this product occurs. seek medical help right away. ⢠symptoms do not improve within 7 days or are accompanied b
Read more...y a fever ⢠nervousness, dizziness or sleeplessness occurs if pregnant or breast-feeding, ask a health professional before use keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).
Do Not Use:
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. stop use and ask a doctor if ⢠an allergic reaction to this product occurs. seek medical help right away. ⢠symptoms do not improve within 7 days or are accompanied by a fever ⢠nervousness, dizziness or sleeplessness occurs if pregnant or breast-feeding, ask a health professional before use keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away (1-800-222-1222).
When Using:
When using this product do not take more than directed. taking more than directed may cause drowsiness.
Dosage and Administration:
Directions ⢠do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet daily with a full glass of water; not more than 1 tablet in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor
Stop Use:
Stop use and ask a doctor if ⢠an allergic reaction to this product occurs. seek medical help right away. ⢠symptoms do not improve within 7 days or are accompanied by a fever ⢠nervousness, dizziness or sleeplessness occurs
Package Label Principal Display Panel:
Principal display panel - 10 mg/240 mg tablet blister pack carton ndc 62011-0071-2 health mart ® compare to claritin-d ® 24 hour active ingredients â original prescription strength ⢠non-drowsy* allergy relief & nasal decongestant loratadine, usp 10 mg/antihistamine pseudoephedrine sulfate, usp 240 mg/nasal decongestant indoor & outdoor allergies 24 hour relief of: nasal & sinus congestion due to colds or allergies sneezing/runny nose/itchy, watery eyes/ itchy throat or nose due to allergies actual size 15 extended-release tablets *when taken as directed. see drug facts panel. principal display panel - 10 mg/240 mg tablet blister pack carton
Further Questions:
Questions? call 1-800-406-7984 keep the carton. it contains important information. see end panel for expiration date. distributed by mckesson one post street, san francisco, ca 94104 www.healthmart.com/healthmartbrand