Sanatos Multi Symptom Daytime
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hci
Pharmadel Llc
Human Otc Drug
NDC 55758-022Sanatos Multi Symptom Daytime also known as Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hci is a human otc drug labeled by 'Pharmadel Llc'. National Drug Code (NDC) number for Sanatos Multi Symptom Daytime is 55758-022. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Sanatos Multi Symptom Daytime drug includes Acetaminophen - 325 mg/15mL Dextromethorphan Hydrobromide - 10 mg/15mL Phenylephrine Hydrochloride - 5 mg/15mL . The currest status of Sanatos Multi Symptom Daytime drug is Active.
Drug Information:
| Drug NDC: | 55758-022 |
| 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 Daytime |
| 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, 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 - 325 mg/15mL
DEXTROMETHORPHAN HYDROBROMIDE - 10 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE - 5 mg/15mL
|
| 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 Dec, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 Jan, 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: | Pharmadel LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1113705
|
| 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: | 0899711001327
|
| UPC stands for Universal Product Code. |
| UNII: | 362O9ITL9D
9D2RTI9KYH
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: | 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 |
|---|
| 55758-022-06 | 177 mL in 1 BOTTLE, PLASTIC (55758-022-06) | 01 Dec, 2014 | 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 15 ml, 1 tablespoon) purposes acetaminophen 325 mg pain reliever/fever reducer dextromethorphan hbr 10 mg cough suppressant phenylephrine hci 5 mg nasal decongestant
Product Elements:
Sanatos multi symptom daytime acetaminophen, dextromethorphan hbr, phenylephrine hci dextromethorphan hydrobromide dextromethorphan anhydrous citric acid water phenylephrine hydrochloride phenylephrine fd&c yellow no. 6 food yellow 3 free acid glycerin sucralose acetaminophen acetaminophen propylene glycol sodium benzoate saccharin sodium saccharin
Indications and Usage:
Uses temporarily relieves common cold/flu symptoms: minor aches & pains headache sore throat fever nasal congestion cough due to minor throat and bronchial irritation
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if adults take more than 4,000 mg if acetaminophen in 24 hours child take more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 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 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 takin
Read more...g this product. with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) when using this product do not use more than directed (see overdose warning) avoid alcoholic drinks stop use and ask a doctor if you get nervos, dizzy or sleepless new symptoms occur fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) redness or swelling is present 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 this and all drugs out of reach of children. overdose warning: in case of overdose, get medical help or contact a poison control center right away. 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. severe liver damage may occur if adults take more than 4,000 mg if acetaminophen in 24 hours child take more than 5 doses in 24 hours taken with other drugs containing acetaminophen adult has 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 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. with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. ask a doctor before use if you have liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) when using this product do not use more than directed (see overdose warning) avoid alcoholic drinks stop use and ask a doctor if you get nervos, dizzy or sleepless new symptoms occur fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) redness or swelling is present 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 this and all drugs out of reach of children. overdose warning: in case of overdose, get medical help or contact a poison control center right away. 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 use more than directed (see overdose warning) avoid alcoholic drinks
Dosage and Administration:
Directions take only as recommended (see overdose warning) use dosage cup or tablespoon (tbsp) do not exceed 4 doses per 24 hrs age dose adults & children 12 years & over 30 ml (2 tbsp) every 6 hours children 6 years to under 12 years 15 ml (1 ttbsp) every 4 hours children 4 years to under 6 years ask a doctor children under 4 years do not use when using daytime and nighttime products, carefully read each label to ensure correct dosing.
Stop Use:
Stop use and ask a doctor if you get nervos, dizzy or sleepless new symptoms occur fever gets worse or lasts more than 3 days pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults) redness or swelling is present cough comes back or occurs with rash or headache that lasts these could be signs of a serious condition.
Overdosage:
Overdose warning: in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Package Label Principal Display Panel:
Principal display panel alcholo-free / antihistamine free ndc 55758-022-06 sanatos® daytime multi-symprom cold & flu relief acetaminophen, dextromethrophan hbr, phenylephrine hci minor aches & pains, fever sore throat nasal decongestion cough new & improved non-drowsy 6 fl oz (177ml) sanatos multi-symptoms day
Further Questions:
Questions? call 1-866-359-3478