Sinus Plus Headache
Acetaminophen, Phenylephrine Hcl
Kroger Company
Human Otc Drug
NDC 30142-466Sinus Plus Headache also known as Acetaminophen, Phenylephrine Hcl is a human otc drug labeled by 'Kroger Company'. National Drug Code (NDC) number for Sinus Plus Headache is 30142-466. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Sinus Plus Headache drug includes Acetaminophen - 325 mg/1 Phenylephrine Hydrochloride - 5 mg/1 . The currest status of Sinus Plus Headache drug is Active.
Drug Information:
| Drug NDC: | 30142-466 |
| 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 Plus Headache |
| 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: | Acetaminophen, Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Kroger Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated |
| 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: | 11 May, 2021 |
| 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: | 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: | Kroger 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. |
| 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 |
|---|
| 30142-466-08 | 2 BLISTER PACK in 1 CARTON (30142-466-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 11 May, 2021 | 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/fever reducer nasal decongestant
Product Elements:
Sinus plus headache acetaminophen, phenylephrine hcl acetaminophen acetaminophen phenylephrine hydrochloride phenylephrine starch, corn crospovidone d&c yellow no. 10 aluminum lake fd&c blue no. 1 aluminum lake fd&c red no. 40 magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified silicon dioxide sodium starch glycolate type a potato stearic acid sucralose talc titanium dioxide 44;466
Indications and Usage:
Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: nasal congestion sinus congestion and pressure headache minor aches and pains helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: blisters rash skin reddening if a skin reaction occurs, stop use and seek medical help right away. do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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. if you have ever had an allergic reaction to this p
Read more...roduct or any of its ingredients ask a doctor before use if you have high blood pressure thyroid disease liver disease diabetes heart disease difficulty in urination due to enlargement of the prostate gland ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product do not exceed recommended dosage. stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of accidental overdose, get medical help or contact a poison control center right away. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do Not Use:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skin reactions. symptoms may include: blisters rash skin reddening if a skin reaction occurs, stop use and seek medical help right away. do not use with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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. if you have ever had an allergic reaction to this product or any of its ingredients ask a doctor before use if you have high blood pressure thyroid disease liver disease diabetes heart disease difficulty in urination due to enlargement of the prostate gland ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product do not exceed recommended dosage. stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. in case of accidental overdose, get medical help or contact a poison control center right away. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
When Using:
When using this product do not exceed recommended dosage.
Dosage and Administration:
Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor
Stop Use:
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel compare to the active ingredients of tylenol® sinus + headache *see bottom panel kroger ® ndc 30142-466-08 daytime sinus + headache acetaminophen pain reliever/fever reducer phenylephrine hcl nasal decongestant non-drowsy sinus headache nasal congestion sinus pressure actual size 24 caplets our pharmacist recommended tamper evident: do not use if package is opened or if blister unit is torn, broken or shows any signs of tampering *tylenol® sinus + headache is a registered trademark of johnson & johnson corporation, new brunswick, new jersey 08933. johnson & johnson corporation is not affiliated with the kroger co. or this product. 50844 rev0721a46608 distributed by the kroger co. cincinnati, ohio 45202 for more product information, scan upc using your kroger app or call 800-632-6900 our brands. our guarantee. love it or your money back. www.kroger.com kroger 44-466c kroger 44-466c
Further Questions:
Questions or comments? 1-800-632-6900