Leader All Day Sinus And Cold D
Naproxen Sodium, Pseudoephedrine Hcl
Cardinal Health 110, Llc. Dba Leader
Human Otc Drug
NDC 70000-0605Leader All Day Sinus And Cold D also known as Naproxen Sodium, Pseudoephedrine Hcl is a human otc drug labeled by 'Cardinal Health 110, Llc. Dba Leader'. National Drug Code (NDC) number for Leader All Day Sinus And Cold D is 70000-0605. This drug is available in dosage form of Tablet, Film Coated, Extended Release. The names of the active, medicinal ingredients in Leader All Day Sinus And Cold D drug includes Naproxen Sodium - 220 mg/1 Pseudoephedrine Hydrochloride - 120 mg/1 . The currest status of Leader All Day Sinus And Cold D drug is Active.
Drug Information:
| Drug NDC: | 70000-0605 |
| 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: | Leader All Day Sinus And Cold D |
| 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: | Naproxen Sodium, Pseudoephedrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cardinal Health 110, Llc. Dba Leader |
| 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: | NAPROXEN SODIUM - 220 mg/1 PSEUDOEPHEDRINE HYDROCHLORIDE - 120 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: | 19 May, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 May, 2026 |
| 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: | ANDA076518 |
| 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: | Cardinal Health 110, LLC. dba Leader
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1367426
|
| 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: | 0096295142037
|
| UPC stands for Universal Product Code. |
| UNII: | 9TN87S3A3C 6V9V2RYJ8N
|
| 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] Anti-Inflammatory Agents Non-Steroidal [CS] Cyclooxygenase Inhibitors [MoA] Nonsteroidal Anti-inflammatory Drug [EPC] 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 |
|---|
| 70000-0605-1 | 20 BLISTER PACK in 1 CARTON (70000-0605-1) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 19 May, 2022 | 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:
Purposes pain reliever/fever reducer nasal decongestant
Product Elements:
Leader all day sinus and cold d naproxen sodium, pseudoephedrine hcl naproxen sodium naproxen pseudoephedrine hydrochloride pseudoephedrine silicon dioxide hypromellose, unspecified lactose monohydrate magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polysorbate 80 povidone, unspecified talc titanium dioxide l417
Indications and Usage:
Uses temporarily relieves these cold, sinus, and flu symptoms: ⢠sinus pressure ⢠minor body aches and pains ⢠headache ⢠nasal and sinus congestion (promotes sinus drainage and restores freer breathing through the nose) ⢠fever
Warnings:
Warnings allergy alert: naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. symptoms may include: ⢠hives ⢠facial swelling ⢠asthma (wheezing) ⢠shock ⢠skin reddening ⢠rash ⢠blisters if an allergic reaction occurs, stop use and seek medical help right away. stomach bleeding warning: this product contains an nsaid, which may cause severe stomach bleeding. the chance is higher if you: ⢠are age 60 or older ⢠have had stomach ulcers or bleeding problems ⢠take a blood thinning (anticoagulant) or steroid drug ⢠take other drugs containing prescription or nonprescription nsaids (aspirin, ibuprofen, naproxen, or others) ⢠have 3 or more alcoholic drinks every day while using this product ⢠take more or for a longer time than directed heart attack and stroke warning: nsaids, except aspirin, increase the risk of heart attack, heart failure, and stroke. these can be fatal. the risk i
Read more...s higher if you use more than directed or for longer than directed. do not use ⢠if you have ever had an allergic reaction to any other pain reliever/fever reducer ⢠right before or after heart surgery ⢠if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinsonâs 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. ⢠in children under 12 years of age ask a doctor before use if ⢠the stomach bleeding warning applies to you ⢠you have a history of stomach problems, such as heartburn ⢠you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke ⢠you are taking a diuretic ⢠you have problems or serious side effects from taking pain relievers or fever reducers ask a doctor or pharmacist before use if you are ⢠under a doctorâs care for any serious condition ⢠taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin ⢠taking any other drug when using this product ⢠take with food or milk if stomach upset occurs stop use and ask a doctor if ⢠you experience any of the following signs of stomach bleeding: ⢠feel faint ⢠vomit blood ⢠have bloody or black stools ⢠have stomach pain that does not get better ⢠you have symptoms of heart problems or stroke: ⢠chest pain ⢠trouble breathing ⢠weakness in one part or side of body ⢠slurred speech ⢠leg swelling ⢠redness or swelling is present in the painful area ⢠any new symptoms appear ⢠fever gets worse or lasts more than 3 days ⢠you have difficulty swallowing or the caplet feels stuck in your throat ⢠you get nervous, dizzy, or sleepless ⢠nasal congestion lasts more than 7 days if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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 allergy alert: naproxen sodium may cause a severe allergic reaction, especially in people allergic to aspirin. symptoms may include: ⢠hives ⢠facial swelling ⢠asthma (wheezing) ⢠shock ⢠skin reddening ⢠rash ⢠blisters if an allergic reaction occurs, stop use and seek medical help right away. stomach bleeding warning: this product contains an nsaid, which may cause severe stomach bleeding. the chance is higher if you: ⢠are age 60 or older ⢠have had stomach ulcers or bleeding problems ⢠take a blood thinning (anticoagulant) or steroid drug ⢠take other drugs containing prescription or nonprescription nsaids (aspirin, ibuprofen, naproxen, or others) ⢠have 3 or more alcoholic drinks every day while using this product ⢠take more or for a longer time than directed heart attack and stroke warning: nsaids, except aspirin, increase the risk of heart attack, heart failure, and stroke. these can be fatal. the risk is higher if you use more than directed or for longer than directed. do not use ⢠if you have ever had an allergic reaction to any other pain reliever/fever reducer ⢠right before or after heart surgery ⢠if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinsonâs 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. ⢠in children under 12 years of age ask a doctor before use if ⢠the stomach bleeding warning applies to you ⢠you have a history of stomach problems, such as heartburn ⢠you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, thyroid disease, diabetes, have trouble urinating due to an enlarged prostate gland, or had a stroke ⢠you are taking a diuretic ⢠you have problems or serious side effects from taking pain relievers or fever reducers ask a doctor or pharmacist before use if you are ⢠under a doctorâs care for any serious condition ⢠taking aspirin for heart attack or stroke, because naproxen may decrease this benefit of aspirin ⢠taking any other drug when using this product ⢠take with food or milk if stomach upset occurs stop use and ask a doctor if ⢠you experience any of the following signs of stomach bleeding: ⢠feel faint ⢠vomit blood ⢠have bloody or black stools ⢠have stomach pain that does not get better ⢠you have symptoms of heart problems or stroke: ⢠chest pain ⢠trouble breathing ⢠weakness in one part or side of body ⢠slurred speech ⢠leg swelling ⢠redness or swelling is present in the painful area ⢠any new symptoms appear ⢠fever gets worse or lasts more than 3 days ⢠you have difficulty swallowing or the caplet feels stuck in your throat ⢠you get nervous, dizzy, or sleepless ⢠nasal congestion lasts more than 7 days if pregnant or breast-feeding, ask a health professional before use. it is especially important not to use naproxen sodium during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. 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 ⢠take with food or milk if stomach upset occurs
Dosage and Administration:
Directions ⢠do not take more than directed ⢠the smallest effective dose should be used ⢠swallow whole; do not crush or chew ⢠drink a full glass of water with each dose ⢠adults and children 12 years and older: 1 caplet every 12 hours; do not take more than 2 caplets in 24 hours ⢠children under 12 years: do not use
Stop Use:
Stop use and ask a doctor if ⢠you experience any of the following signs of stomach bleeding: ⢠feel faint ⢠vomit blood ⢠have bloody or black stools ⢠have stomach pain that does not get better ⢠you have symptoms of heart problems or stroke: ⢠chest pain ⢠trouble breathing ⢠weakness in one part or side of body ⢠slurred speech ⢠leg swelling ⢠redness or swelling is present in the painful area ⢠any new symptoms appear ⢠fever gets worse or lasts more than 3 days ⢠you have difficulty swallowing or the caplet feels stuck in your throat ⢠you get nervous, dizzy, or sleepless ⢠nasal congestion lasts more than 7 days
Package Label Principal Display Panel:
Package/label principal display panel leader ⢠non-drowsy all day sinus & cold-d naproxen sodium, 220 mg pseudoephedrine hydrochloride, 120 mg extended-release tablet pain reliever/fever reducer (nsaid) | nasal decongestant 12-hour multi-symptom relief of: sinus pressure, headache, sinus congestion, nasal congestion & body aches 1 caplet â 12 hours actual size compare to aleve-d ® sinus & cold active ingredients 100% money back guarantee 20 caplets** **capsule-shaped tablets all day sinus & cold-d carton image 1 all day sinus & cold-d carton image 2 all day sinus & cold-d carton image 3
Further Questions:
Questions or comments? 1-800-719-9260