Mucus Relief Severe Congestion Cough Night Time Cold And Flu Maximum Strength
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci, Acetaminophen, Diphenhydramine Hci, Phenylephrine Hci
Dolgencorp, Inc. (dollar General & Rexall)
Human Otc Drug
NDC 55910-562Mucus Relief Severe Congestion Cough Night Time Cold And Flu Maximum Strength also known as Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci, Acetaminophen, Diphenhydramine Hci, Phenylephrine Hci is a human otc drug labeled by 'Dolgencorp, Inc. (dollar General & Rexall)'. National Drug Code (NDC) number for Mucus Relief Severe Congestion Cough Night Time Cold And Flu Maximum Strength is 55910-562. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Mucus Relief Severe Congestion Cough Night Time Cold And Flu Maximum Strength drug includes . The currest status of Mucus Relief Severe Congestion Cough Night Time Cold And Flu Maximum Strength drug is Active.
Drug Information:
| Drug NDC: | 55910-562 |
| 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: | Mucus Relief Severe Congestion Cough Night Time Cold And Flu Maximum Strength |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Mucus Relief Severe Congestion Cough Night Time Cold And Flu |
| 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: | Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci, Acetaminophen, Diphenhydramine Hci, Phenylephrine Hci |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Dolgencorp, Inc. (dollar General & Rexall) |
| 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: | 31 Mar, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 06 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: | 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: | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1043543
1375932
1730192
|
| 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: | 0349580462120
|
| 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 |
|---|
| 55910-562-12 | 1 KIT in 1 KIT (55910-562-12) * 177 mL in 1 BOTTLE, PLASTIC * 177 mL in 1 BOTTLE, PLASTIC | 31 Mar, 2018 | 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 for nighttime pain reliever/fever reducer antihistamine/cough suppressant nasal decongestant
Purpose for daytime cough suppressant expectorant nasal decongestant
Product Elements:
Mucus relief severe congestion cough night time cold and flu maximum strength dextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci daytime mucus relief severe congestion and cough maximum strength dextromethorphan hbr, guaifenesin, phenylephrine hci dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine fd&c blue no. 1 propylene glycol water fd&c red no. 40 anhydrous citric acid edetate calcium disodium sodium benzoate trisodium citrate dihydrate glycerin propyl gallate sorbitol sucralose xanthan gum nighttime cold and flu maximum strength acetaminophen, diphenhydraminehci, phenylephrine hci acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine glycerin propylene glycol water sorbitol anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 sodium benzoate sodium citrate sucralose propyl gallate xanthan gum edetate calcium disodium
Indications and Usage:
Uses nighttime temporarily relieves these common cold and flu symptoms cough nasal congestion minor aches and pains sore throat headache runny nose sneezing temporarily reduces fever controls cough to help you get to sleep daytime helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants the intensity of coughing the impulse to cough to help you get to sleep nasal congestion due to a cold
Warnings:
Warnings nighttime liver warnin g: this product contain 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. sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use nighttime with any drug containing acetaminophen (prescription or nonprescription) . if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other drug containing diphenhydramine, even one used on the skin if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric
Read more... 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 for children under 12 years of age daytime for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (maoi)(certain drugs for depression,psychiatic 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 nighttime liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) daytime heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphtsema cough that occurs with too much phlegm (mucus) ask a doctor or pharmacist before use if you are nighttime you are taking the blood thinning drug warfarin you are taking sedative or tranquilizers when using these products nighttime do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicile or operating machinery daytime do not use more than directed stop use and ask a doctor if nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 7 days fever gets worse, or last more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. these could be a signs of a serious condition daytime nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, nighttime and daytime ask a health professional before use. keep out of reach of children. nighttime overdose warning : taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. daytime in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away.
Do Not Use:
Warnings nighttime liver warnin g: this product contain 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. sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use nighttime with any drug containing acetaminophen (prescription or nonprescription) . if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other drug containing diphenhydramine, even one used on the skin 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 for children under 12 years of age daytime for children under 12 years of age if you are now taking a prescription monoamine oxidase inhibitor (maoi)(certain drugs for depression,psychiatic 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 nighttime liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough that occurs with too much phlegm (mucus) daytime heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphtsema cough that occurs with too much phlegm (mucus) ask a doctor or pharmacist before use if you are nighttime you are taking the blood thinning drug warfarin you are taking sedative or tranquilizers when using these products nighttime do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicile or operating machinery daytime do not use more than directed stop use and ask a doctor if nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 7 days fever gets worse, or last more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. these could be a signs of a serious condition daytime nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, nighttime and daytime ask a health professional before use. keep out of reach of children. nighttime overdose warning : taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. daytime in case of overdose, get medical help or contact a poison control center (1-800-222-1222) right away.
When Using:
When using these products nighttime do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicile or operating machinery daytime do not use more than directed
Dosage and Administration:
Directions nighttime do not take more than directed (see overdose warning ) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided. do not use any other dosing device keep dosing cup with product ml = mililiter dose as follows or as directed by a doctor adults and children 12 years and older: 20 ml every 4 hours while symptoms last children under 12 years of age: do not use daytime do not take more than 6 doses in any 24-hours period measure only with dosing cup provided. do not use any other dosing device. shake well before using keep dosing cup with product ml = milliliter adults and children 12 years of age and older: 20 ml every 4 hours children under 12 years of age: do not use
Stop Use:
Stop use and ask a doctor if nighttime nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 7 days fever gets worse, or last more than 3 days redness or swelling is present new symptoms occur cough comes back or occurs with rash or headache that lasts. these could be a signs of a serious condition daytime nervousness, dizziness or sleeplessness occur symptoms do not get better within 7 days or occur with fever cough comes back or occurs with rash or headache that lasts. these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel compare to the active ingredients of maximum strength mucinex® fast-max® severe congestion & cough & night time cold & flu* nighttime maximum strength fast acting night time cold & flu multi-symptom relief acetaminophen diphenhydraminehci phenylephrine hci pain reliever/fever reducer antihistamine/cough suppressant nasal decongestant for ages 12 years and over daytime maximum strength fast acting mucus relief severe congestion & cough multi-symptom relief dextromethorphan hbr guaifenesin phenylephrine hci cough suppressant expectorant nasal decongestant for ages 12 years and over tamper evident: do not use if printed safety seal around or under cap is broken or missing. ââthis product is not manufactured or distributed by reckitt benckiser, distributor of maximum strength mucinex® fast-max® severe congestion & cough and nighttime cold & flu. distributed by old east main co. 100 mission ridge goodlettsville, tn 37072
Product label dollar general health maximum strength mucus relief severe congestion and cough, cold flu dextromethorphan hbr 20 mg, guaifenesin 400 mg, phenylephrine hcl 10 mg, acetaminophen 650 mg, diphenhydramine hcl 25 mg, phenylephrine hcl 10 mg
Further Questions:
Questions or comments? nighttime and daytime call 1-888-309-9030