Sinus Headache Pe Non- Drowsy Maximum Strength
Acetaminophen And Phenylephrine Hcl
American Sales Company
Human Otc Drug
NDC 41520-270Sinus Headache Pe Non- Drowsy Maximum Strength also known as Acetaminophen And Phenylephrine Hcl is a human otc drug labeled by 'American Sales Company'. National Drug Code (NDC) number for Sinus Headache Pe Non- Drowsy Maximum Strength is 41520-270. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Sinus Headache Pe Non- Drowsy Maximum Strength drug includes Acetaminophen - 325 mg/1 Phenylephrine Hydrochloride - 5 mg/1 . The currest status of Sinus Headache Pe Non- Drowsy Maximum Strength drug is Active.
Drug Information:
| Drug NDC: | 41520-270 |
| 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: | Sinus Headache Pe Non- Drowsy Maximum Strength |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Sinus Headache Pe Non- Drowsy |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Maximum Strength |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Acetaminophen And Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | American Sales Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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: | ACETAMINOPHEN - 325 mg/1
PHENYLEPHRINE HYDROCHLORIDE - 5 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: | OTC MONOGRAPH FINAL |
| 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: | 12 Jun, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | part341 |
| 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: | American Sales Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1046378
|
| 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: | 0341520318450
|
| UPC stands for Universal Product Code. |
| UNII: | 362O9ITL9D
04JA59TNSJ
|
| 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 alpha1-Agonists [MoA]
alpha-1 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 |
|---|
| 41520-270-24 | 24 TABLET in 1 BLISTER PACK (41520-270-24) | 12 Jun, 2014 | 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 pain reliever nasal decongestant
Product Elements:
Sinus headache pe non- drowsy maximum strength acetaminophen and phenylephrine hcl acetaminophen acetaminophen phenylephrine hydrochloride phenylephrine starch, corn hypromellose 2208 (100 mpa.s) cellulose, microcrystalline polyethylene glycol, unspecified stearic acid titanium dioxide crospovidone (12 mpa.s at 5%) fd&c yellow no. 6 az270
Indications and Usage:
Uses temporarily relieves: â nasal and sinus congestion â minor aches and pains, headaches
Warnings:
Warnings liver warning: âthis product contains acetaminophen. severe liver damage may occur if you take â more than 8 caplets in 24 hours, which is the maximum daily amount â with other drugs containing acetaminophen â 3 or more alcoholic drinks every day while using this product. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include â skin reddening â blisters â rash if a skin reaction occurs, stop use and seek medical help right away. do not use â 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 â with other products containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen
Read more..., ask a doctor or pharmacist. ask a doctor before use if you have â liver disease â heart disease â high blood pressure â thyroid disease â diabetes â trouble urinating due to an enlarged prostate ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product do not use more than directed. stop use and ask a doctor if â redness or swelling is present â new symptoms occur â you get nervous, dizzy or sleepless â pain gets worse or lasts more than 7 days â fever gets worse or lasts more than 3 days â you may report side effects to 1-888-952-0050
Do Not Use:
Warnings liver warning: âthis product contains acetaminophen. severe liver damage may occur if you take â more than 8 caplets in 24 hours, which is the maximum daily amount â with other drugs containing acetaminophen â 3 or more alcoholic drinks every day while using this product. allergy alert: acetaminophen may cause severe skin reactions. symptoms may include â skin reddening â blisters â rash if a skin reaction occurs, stop use and seek medical help right away. do not use â 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 â with other products containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if you have â liver disease â heart disease â high blood pressure â thyroid disease â diabetes â trouble urinating due to an enlarged prostate ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product do not use more than directed. stop use and ask a doctor if â redness or swelling is present â new symptoms occur â you get nervous, dizzy or sleepless â pain gets worse or lasts more than 7 days â fever gets worse or lasts more than 3 days â you may report side effects to 1-888-952-0050
When Using:
When using this product do not use more than directed.
Dosage and Administration:
Directions â adults and children 12 years of age and older: take 2 tablets every 4-6 hours â do not take more than 8 tablets in 24 hours â do not use in children under 12 years of age. this will provide more than the recommended dose (overdose) and could cause serious health problems
Stop Use:
Stop use and ask a doctor if â redness or swelling is present â new symptoms occur â you get nervous, dizzy or sleepless â pain gets worse or lasts more than 7 days â fever gets worse or lasts more than 3 days â you may report side effects to 1-888-952-0050
Package Label Principal Display Panel:
Package/label principal display panel careone® compare to the active ingredient in sudafed pe® pressure + pain** sinus pressure + pain pe pain reliever - acetaminophen nasal decongestant - phenylephrine hcl max strength relieves: sinus pain & headache sinus pressure nasal & sinus congestion does not contain pseudoephedrine non-drowsy 24 coated caplets* *capsule - shaped tablets distributed by foodhold u.s.a., llc landover, md 20785 1-877-846-9949 ©2016 s&s brands, llc quality guaranteed or your money back lb0604 r0316 **this product is not manufactured or distributed by mcneil consumer healthcare, owner of the registered trademark sudafed pe® pressure + pain. care one sinus pressure + pain pe care one sinus pressure + pain pe