Sinus Pain And Congestion
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl
Cvs Pharmacy
Human Otc Drug
NDC 59779-779Sinus Pain And Congestion also known as Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hcl is a human otc drug labeled by 'Cvs Pharmacy'. National Drug Code (NDC) number for Sinus Pain And Congestion is 59779-779. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Sinus Pain And Congestion drug includes . The currest status of Sinus Pain And Congestion drug is Active.
Drug Information:
| Drug NDC: | 59779-779 |
| 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 Pain And Congestion |
| 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, Chlorpheniramine Maleate, Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cvs Pharmacy |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | 26 Jul, 2005 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 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, 2024 |
| 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: | CVS Pharmacy
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1046378
1046781
1046799
|
| 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: | |
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 59779-779-08 | 1 KIT in 1 CARTON (59779-779-08) * 12 TABLET, FILM COATED in 1 BLISTER PACK * 12 TABLET, FILM COATED in 1 BLISTER PACK | 26 Jul, 2005 | 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
Purpose pain reliever/fever reducer antihistamine nasal decongestant
Product Elements:
Sinus pain and congestion acetaminophen, chlorpheniramine maleate, phenylephrine hcl sinus pain and congestion daytime acetaminophen, phenylephrine hcl acetaminophen acetaminophen phenylephrine hydrochloride phenylephrine starch, corn crospovidone, unspecified 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 sinus pain and congestion nighttime acetaminophen, chlorpheniramine maleate, phenylephrine hcl acetaminophen acetaminophen chlorpheniramine maleate chlorpheniramine phenylephrine hydrochloride phenylephrine starch, corn crospovidone, unspecified 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;455
Indications and Usage:
Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: nasal congestion headache minor aches and pains sinus congestion and pressure runny nose and sneezing (nighttime only) promotes sinus drainage helps clear nasal passages helps decongest sinus openings and 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: skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away. do not use if you have ever had an allergic reaction to this product or any of its ingredients 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 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
Read more...before taking this product. ask a doctor before use if you have heart disease high blood pressure liver disease thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis (nighttime only) glaucoma (nighttime only) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (nighttime only) when using this product do not exceed recommended dosage use caution when driving a motor vehicle or operating machinery (nighttime only) drowsiness may occur (nighttime only) excitability may occur, especially in children (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) avoid alcoholic beverages (nighttime only) 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. read each section carefully. do not take daytime and nighttime products at the same time.
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: skin reddening blisters rash if a skin reaction occurs, stop use and seek medical help right away. do not use if you have ever had an allergic reaction to this product or any of its ingredients 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 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 high blood pressure liver disease thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis (nighttime only) glaucoma (nighttime only) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers (nighttime only) when using this product do not exceed recommended dosage use caution when driving a motor vehicle or operating machinery (nighttime only) drowsiness may occur (nighttime only) excitability may occur, especially in children (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) avoid alcoholic beverages (nighttime only) 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. read each section carefully. do not take daytime and nighttime products at the same time.
When Using:
When using this product do not exceed recommended dosage use caution when driving a motor vehicle or operating machinery (nighttime only) drowsiness may occur (nighttime only) excitability may occur, especially in children (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) avoid alcoholic beverages (nighttime only)
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 â¥ï¸cvs health ® sinus daytime - non-drowsy nighttime - to let you sleep sinus pain & congestion sinus pain & congestion acetaminophen acetaminophen pain reliever, fever reducer pain reliever, fever reducer phenylephrine hcl chlorpheniramine maleate nasal decongestant antihistamine phenylephrine hcl nasal decongestant relieves: relieves: headache, sinus pressure fever, headache, sinus pressure, & nasal congestion nasal congestion & runny nose 12 caplets 12 caplets with cool blast flavor with cool blast flavor actual size actual size 24 total caplets tamper evident: do not use if package is opened or if blister unit is torn, broken or shows any signs of tampering distributed by: cvs pharmacy, inc. one cvs drive, woonsocket, ri 02895 © 2023 cvs/pharmacy cvs.com® 1-800-shop cvs v-19849 100% money back guaranteed. cvs.com/returnpolicy 50844 rev0818b45546608 do not take the daytime and nighttime caplets at the same time. cvs 44-455c466 cvs 44-455c466
Further Questions:
Questions or comments? 1-800-426-9391