Sanatos Multi Symptom
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci
Pharmadel Llc
Human Otc Drug
NDC 55758-361Sanatos Multi Symptom also known as Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci is a human otc drug labeled by 'Pharmadel Llc'. National Drug Code (NDC) number for Sanatos Multi Symptom is 55758-361. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Sanatos Multi Symptom drug includes Acetaminophen - 325 mg/1 Dextromethorphan Hydrobromide - 15 mg/1 Guaifenesin - 200 mg/1 Phenylephrine Hydrochloride - 5 mg/1 . The currest status of Sanatos Multi Symptom drug is Active.
Drug Information:
| Drug NDC: | 55758-361 |
| 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: | Sanatos Multi Symptom |
| 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 Hbr, Guaifenesin, Phenylephrine Hci |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pharmadel Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| 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 - 15 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: | 01 Aug, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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: | Pharmadel LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1367204
|
| 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 |
|---|
| 55758-361-02 | 2 TABLET in 1 PACKET (55758-361-02) | 01 Aug, 2020 | N/A | No |
| 55758-361-99 | 50 PACKET in 1 CARTON (55758-361-99) / 2 TABLET in 1 PACKET (55758-361-02) | 01 Aug, 2020 | 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:
Active ingredients (in each tablet) purposes acetaminophen 325 mg pain reliever/ fever reducer dextromethorphan hbr 15 mg cough suppressant guaifenesin 200 mg expectorant phenylephrine hci 5 mg nasal decongestant
Product Elements:
Sanatos multi symptom acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hci silicon dioxide stearic acid povidone k30 talc starch, corn cellulose, microcrystalline povidone-iodine acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin phenylephrine hydrochloride phenylephrine a12
Indications and Usage:
Uses temporarily relieves common cold/flu symptoms: minor aches & pains headache sore throat nasal congestion due to hay fever sinus congestion helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skine 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 vomitting, consult a doctor promptly. do not use with any 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 stopp
Read more...ing the maoi, asl a doctor or pharmacist before taking this product. for more than 7 days for pain and 3 days or fever, unless directed by a doctor. ask a doctor before use if you have liver disease heart disease high blood pressure throid disease diabetes trouble urinating due to enlarged prostate gland a cough that is accompained by excessive phlegm (mucus) a persistant or chronic cough such as occurs with smoking, asthma or emphysema ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin 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.
Liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skine 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 vomitting, consult a doctor promptly.
Do Not Use:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product allergy alert: acetaminophen may cause severe skine 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 vomitting, consult a doctor promptly. do not use with any 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, asl a doctor or pharmacist before taking this product. for more than 7 days for pain and 3 days or fever, unless directed by a doctor. ask a doctor before use if you have liver disease heart disease high blood pressure throid disease diabetes trouble urinating due to enlarged prostate gland a cough that is accompained by excessive phlegm (mucus) a persistant or chronic cough such as occurs with smoking, asthma or emphysema ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin 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.
Liver warning: this product contains acetaminophen. severe liver damage may occur if you take more than 8 tablets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skine 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 vomitting, consult a doctor promptly.
Dosage and Administration:
Directions do not exceed recommended dosage adults and children 12 years of age and over: take 2 tablets every 6-8 hours; do not exceed 8 tablets in a 24-hour period children under 12 years of age: consult a doctor
Package Label Principal Display Panel:
Prinicpal display panels display pdp packet pdp pdp_sanatos pdp_pouch_sanatos
Further Questions:
Questions & comments? +1-866-359-3478 (m-f) 9am to 5 pm est or www.pharmadel.com