Day And Night Sinus Maximum Strength
Acetaminophen, Diphenhydramine Hcl, Guaifenesin, Phenylephrine Hcl
Wal-mart Stores Inc
Human Otc Drug
NDC 49035-996Day And Night Sinus Maximum Strength also known as Acetaminophen, Diphenhydramine Hcl, Guaifenesin, Phenylephrine Hcl is a human otc drug labeled by 'Wal-mart Stores Inc'. National Drug Code (NDC) number for Day And Night Sinus Maximum Strength is 49035-996. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Day And Night Sinus Maximum Strength drug includes . The currest status of Day And Night Sinus Maximum Strength drug is Active.
Drug Information:
| Drug NDC: | 49035-996 |
| 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: | Day And Night Sinus Maximum Strength |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Day And Night Sinus |
| 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, Diphenhydramine Hcl, Guaifenesin, Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Wal-mart Stores Inc |
| 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: | 30 Jun, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 21 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: | Wal-Mart Stores Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1046751
1243679
1356113
|
| 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: | 0681131078245
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 49035-996-09 | 1 KIT in 1 CARTON (49035-996-09) * 10 TABLET, FILM COATED in 1 BLISTER PACK * 10 TABLET, FILM COATED in 1 BLISTER PACK | 30 Jun, 2013 | 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 expectorant nasal decongestant
Purpose pain reliever antihistamine nasal decongestant
Product Elements:
Day and night sinus maximum strength acetaminophen, diphenhydramine hcl, guaifenesin, phenylephrine hcl day and night sinus day acetaminophen, guaifenesin, phenylephrine hcl acetaminophen acetaminophen guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine starch, corn crospovidone fd&c red no. 40 fd&c yellow no. 6 magnesium stearate maltodextrin microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified silicon dioxide sodium starch glycolate type a potato stearic acid talc titanium dioxide 44;615 day and night sinus night acetaminophen, diphenhydramine hcl, phenylephrine hcl acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine starch, corn croscarmellose sodium crospovidone fd&c blue no. 1 aluminum lake hypromellose, unspecified magnesium stearate microcrystalline cellulose polydextrose polyethylene glycol, unspecified povidone, unspecified silicon dioxide stearic acid titanium dioxide triacetin 44;544
Indications and Usage:
Uses temporarily relieves: nasal congestion headache minor aches and pains sinus congestion and pressure runny nose and sneezing (nighttime only) promotes nasal and/or sinus drainage helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (daytime only)
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 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 with any other product containing diphenhydramine, even one used on skin (nighttime only) ask a doctor before use if you have heart disease liver disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (daytime only) cough that occurs with too much phlegm (mucus) (daytime only) 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 excitability may occur, especially in children (nighttime only) marked drowsiness may occur (nighttime only) avoid alcoholic beverages (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) use caution when driving a motor vehicle or operating machinery (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 cough gets worse or lasts more than 7 days (daytime only) cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. (daytime only) 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 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 with any other product containing diphenhydramine, even one used on skin (nighttime only) ask a doctor before use if you have heart disease liver disease diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (daytime only) cough that occurs with too much phlegm (mucus) (daytime only) 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 excitability may occur, especially in children (nighttime only) marked drowsiness may occur (nighttime only) avoid alcoholic beverages (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) use caution when driving a motor vehicle or operating machinery (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 cough gets worse or lasts more than 7 days (daytime only) cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. (daytime only) 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 excitability may occur, especially in children (nighttime only) marked drowsiness may occur (nighttime only) avoid alcoholic beverages (nighttime only) alcohol, sedatives, and tranquilizers may increase drowsiness (nighttime only) use caution when driving a motor vehicle or operating machinery (nighttime only)
Dosage and Administration:
Directions do not take more than directed do not take more than 12 caplets of daytime and nighttime products in any 24-hour period adults and children 12 years and over: take 2 caplets every 4 hours children under 12 years: do not use
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 cough gets worse or lasts more than 7 days (daytime only) cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. (daytime only)
Package Label Principal Display Panel:
Principal display panel equate⢠ndc 49035-996-09 compare to maximum strength mucinex® sinus-max⢠day & night active ingredients* maximum strength day & night sinus day acetaminophen - pain reliever, guaifenesin - expectorant, phenylephrine hcl - nasal decongestant ⢠relieves sinus pressure, headache & congestion ⢠thins & loosens mucus 10 daytime caplets actual size night acetaminophen - pain reliever, diphenhydramine hcl - antihistamine, phenylephrine hcl - nasal decongestant ⢠relieves nasal congestion, sinus pressure & pain ⢠relieves runny nose & sneezing 10 nighttime caplets actual size tamper evident: do not use if package is opened or if blister unit is torn, broken or shows any signs of tampering satisfaction guaranteed - or we'll replace it or give you your money back. for questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915. distributed by: walmart inc., bentonville, ar 72716 *this product is not manufactured or distributed by reckitt benckiser llc, owner of the registered trademark maximum strength mucinex® sinus-max⢠day & night. 50844 rev0219a61554409 equate 44-615544 equate 44-615544
Further Questions:
Questions or comments? 1-888-287-1915