Sanatos X
Acetaminophen, Dextromethorphan Hbr,guaifenesin, Phenylephrine Hci
Pharmadel Llc
Human Otc Drug
NDC 55758-311Sanatos X 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 X is 55758-311. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Sanatos X drug includes Acetaminophen - 650 mg/1 Dextromethorphan Hydrobromide - 20 mg/1 Guaifenesin - 400 mg/1 Phenylephrine Hydrochloride - 10 mg/1 . The currest status of Sanatos X drug is Active.
Drug Information:
| Drug NDC: | 55758-311 |
| 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 X |
| 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: | Liquid |
| 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 - 650 mg/1
DEXTROMETHORPHAN HYDROBROMIDE - 20 mg/1
GUAIFENESIN - 400 mg/1
PHENYLEPHRINE HYDROCHLORIDE - 10 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: | 03 Dec, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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: | 1593450
|
| 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]
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 |
|---|
| 55758-311-06 | 1 BOTTLE, WITH APPLICATOR in 1 BOX (55758-311-06) / 1 LIQUID in 1 BOTTLE, WITH APPLICATOR | 03 Dec, 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:
Active ingredients (in each 20 ml) purposes acetaminophen 650mg ...... pain reliever/fever reducer dextromethorphan hbr 20 mg ............. cough suppressant guaifenesin 400 mg ..................................... expectorant phenylephrine hci 10 mg................... nasal decongestant
Product Elements:
Sanatos x acetaminophen, dextromethorphan hbr,guaifenesin, phenylephrine hci dextromethorphan hydrobromide dextromethorphan anhydrous citric acid edetate disodium edetic acid acetaminophen acetaminophen guaifenesin guaifenesin fd&c blue no. 1 propylene glycol propyl gallate sorbitol sucralose xanthan gum phenylephrine hydrochloride phenylephrine fd&c red no. 40 glycerin water sodium benzoate
Indications and Usage:
Uses temporarily relieves these common cold/ flu symptoms: minor aches and pains headache sore throat cough due to minor throat and bronchial irritation helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes make coughs more productive nasal congestion stuffy nose hay fever temporarily reduces fever
Warnings:
Warnings liver warning: this product contains acetaminophen . severe liver damage may occur if you: take more than 6 doses in 24 hours, which is the maximum daily amount take with other drugs containing acetaminophen have 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 an allergic reaction occurs, stop use and seek medical help right away. sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. consult physician 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 or your child are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease),
Read more... or for 2 weeks after stopping the maoi drug. if you do not know if your childâs or your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin ask a doctor before use if you have liver disease high blood pressure a cough that is accompanied with excessive phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, bronchitis, or emphysema diffculty in urination due to enlargement of the prostate gland heart disease thyroid disease diabetes stop use and ask a doctor if skin rash appears symptoms persist for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur nervousness, dizziness, or sleeplessness occur these could be signs of a serious condition. if pregnant or breastfeeding, 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. prompt 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 . severe liver damage may occur if you: take more than 6 doses in 24 hours, which is the maximum daily amount take with other drugs containing acetaminophen have 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 an allergic reaction occurs, stop use and seek medical help right away. sore throat warning: severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. consult physician 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 or your child 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 childâs or your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin ask a doctor before use if you have liver disease high blood pressure a cough that is accompanied with excessive phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, bronchitis, or emphysema diffculty in urination due to enlargement of the prostate gland heart disease thyroid disease diabetes stop use and ask a doctor if skin rash appears symptoms persist for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur nervousness, dizziness, or sleeplessness occur these could be signs of a serious condition. if pregnant or breastfeeding, 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. prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage and Administration:
Directions do not take more than directed dosing cup included do not take more than 6 doses in any 24-hour period this product is not intended for use in children under 12 years of age age dose adults & children 12 years of age & over 20 ml every 4 hours children under 12 years of age do not use
Stop Use:
Stop use and ask a doctor if skin rash appears symptoms persist for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur nervousness, dizziness, or sleeplessness occur these could be signs of a serious condition.
Package Label Principal Display Panel:
Principal display panel maximum strength ⢠mÃxima potencia sanatos® x fast action/acciÃn rÃpida acetaminophen dextromethorphan hbr, guaifenesin, phenylephrine hci/acetaminofÃn dextrometorfano hbr, guaifenesina, fenilefrina hcl cough, cold & sore throat/tos, resfriado y dolor de garganta fever/fiebre aches and pains/dolores y molestias leves headache/dolor de cabeza expectorant/expectorante nasal decongestant/descongestivo nasal for ages 12+/para edades 12+ 6 fl oz (177 ml) santos x
Further Questions:
Questions or comments? 1-866-359-3478 (m-f) 9 am to 5 pm est or www.pharmadel.com