Maximum Strength Non Drowsy Daytime Severe Cold And Flu
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
Wal-mart Stores Inc
Human Otc Drug
NDC 79903-162Maximum Strength Non Drowsy Daytime Severe Cold And Flu also known as Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride is a human otc drug labeled by 'Wal-mart Stores Inc'. National Drug Code (NDC) number for Maximum Strength Non Drowsy Daytime Severe Cold And Flu is 79903-162. This drug is available in dosage form of Capsule, Liquid Filled. The names of the active, medicinal ingredients in Maximum Strength Non Drowsy Daytime Severe Cold And Flu drug includes Acetaminophen - 325 mg/1 Dextromethorphan Hydrobromide - 10 mg/1 Guaifenesin - 200 mg/1 Phenylephrine Hydrochloride - 5 mg/1 . The currest status of Maximum Strength Non Drowsy Daytime Severe Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 79903-162 |
| 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: | Maximum Strength Non Drowsy Daytime Severe Cold And Flu |
| 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, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride |
| 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: | Capsule, Liquid Filled |
| 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
DEXTROMETHORPHAN HYDROBROMIDE - 10 mg/1
GUAIFENESIN - 200 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: | 24 Oct, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 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: | 1656815
|
| 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. |
| NUI: | N0000193956
N0000008867
N0000009560
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 362O9ITL9D
9D2RTI9KYH
495W7451VQ
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 EPC: | Expectorant [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Decreased Respiratory Secretion Viscosity [PE]
Increased Respiratory Secretions [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Adrenergic alpha1-Agonists [MoA]
Decreased Respiratory Secretion Viscosity [PE]
Expectorant [EPC]
Increased Respiratory Secretions [PE]
Sigma-1 Agonist [EPC]
Sigma-1 Receptor Agonists [MoA]
Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]
Uncompetitive NMDA Receptor Antagonists [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 |
|---|
| 79903-162-24 | 2 BLISTER PACK in 1 CARTON (79903-162-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 24 Oct, 2022 | 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 cough suppressant expectorant nasal decongestant
Product Elements:
Maximum strength non drowsy daytime severe cold and flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride fd&c yellow no. 6 gelatin glycerin polyethylene glycol, unspecified povidone propylene glycol sorbitol sorbitan titanium dioxide acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine 341;a13
Indications and Usage:
Uses ⢠for the temporary relief of the following cold/flu symptoms: ⢠minor aches and pains ⢠headache ⢠sore throat ⢠nasal congestion ⢠cough ⢠helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive ⢠temporarily reduces fever
Warnings:
Warnings liver warning: this product contains acetaminophen. the maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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 ⢠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 in
Read more...hibitor (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. ⢠if you have ever had an allergic reaction to this product or any of its ingredients. ask a doctor before use if you have ⢠liver disease ⢠heart disease ⢠high blood pressure ⢠thyroid disease ⢠diabetes ⢠trouble urinating due to an enlarged prostate gland ⢠persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ⢠cough that occurs with too much phlegm (mucus) 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, nasal congestion or cough 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 comes back or occurs with rash or headache that lasts. 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 overdose, get medical help or contact a poison control center right away (1-800-222-1222). quick 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. the maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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 ⢠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. ⢠if you have ever had an allergic reaction to this product or any of its ingredients. ask a doctor before use if you have ⢠liver disease ⢠heart disease ⢠high blood pressure ⢠thyroid disease ⢠diabetes ⢠trouble urinating due to an enlarged prostate gland ⢠persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema ⢠cough that occurs with too much phlegm (mucus) 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, nasal congestion or cough 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 comes back or occurs with rash or headache that lasts. 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 overdose, get medical help or contact a poison control center right away (1-800-222-1222). quick 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 & 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, nasal congestion or cough 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 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 vicks® dayquil® severe cold & flu active ingredientsâ maximum strength daytime non-drowsy severe cold & flu acetaminophen / pain reliever / fever reducer dextromethorphan hbr / cough suppressant guaifenesin / expectorant phenylephrine hci / nasal decongestant relief of: headache, fever, sore throat, minor aches & pains nasal/sinus congestion & sinus pressure chest congestion cough 24 softgels carton
Further Questions:
Questions or comments? 1-888-287-1915