Sanatos Day And Night Multi Symptom

Acetaminophen,dextromethorphan Hbr,doxylamine Succinate

Pharmadel
Human Otc Drug
NDC 55758-142

Sanatos Day And Night Multi Symptom also known as Acetaminophen,dextromethorphan Hbr,doxylamine Succinate is a human otc drug labeled by 'Pharmadel'. National Drug Code (NDC) number for Sanatos Day And Night Multi Symptom is 55758-142. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Sanatos Day And Night Multi Symptom drug includes . The currest status of Sanatos Day And Night Multi Symptom drug is Active.

Drug Information:

Drug NDC:	55758-142
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 Day And Night 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,doxylamine Succinate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Pharmadel
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:	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 NOT 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:	30 Sep, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	10 Jun, 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
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1086997 1094549
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.
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
55758-142-24	1 BLISTER PACK in 1 CARTON (55758-142-24) / 1 KIT in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK	30 Sep, 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.

Other medicines with the same generic name

Sanatos Day And Night Multi Symptom

Acetaminophen,dextromethorphan Hbr,doxylamine Succinate

Kit
Pharmadel
NDC: 55758-142

Purpose:

Daytime relief active ingredients (in each liquicap) purposes acetaminophen 325 mg....... pain reliever/ fever reducer dextromethorphan hbr 10 mg.............. cough suppressant phenylephrine hci 5 mg....................... nasal decongestant nighttime relief active ingredients (in each liquicap) purposes acetaminophen 325 mg........ pain reliever/ fever reducer dextromethorphan hbr 15 mg............... cough suppressant doxylamine succinate 6.25 mg........................ antihistamine

Product Elements:

Sanatos day and night multi symptom acetaminophen,dextromethorphan hbr,doxylamine succinate sanatos daytime multi symptom acetaminophen,dextromethorphan hbr, phenylephrine hcl titanium dioxide gelatin acetaminophen acetaminophen phenylephrine hydrochloride phenylephrine fd&c red no. 40 fd&c yellow no. 6 food yellow 3 free acid dextromethorphan hydrobromide dextromethorphan glycerin polyethylene glycol, unspecified water sorbitol sorbitan liquicap sanatos nighttime multi symptom acetaminophen,dextromethorphan hbr, doxylamine succinate titanium dioxide gelatin acetaminophen acetaminophen doxylamine succinate doxylamine d&c yellow no. 10 fd&c blue no. 1 dextromethorphan hydrobromide dextromethorphan glycerin polyethylene glycol, unspecified water sorbitol sorbitan liquicap

Indications and Usage:

Use daytime relief temporarily relieves common cold/ï¬u symptoms: headache minor aches and pains sore throat nasal and sinus congestion stuffy nose temporarily reduces fever nighttime relief temporarily relieves common cold/ï¬u symptoms: cough due to minor throat and bronchial irritation headache minor aches and pains sneezing sore throat runny nose itchy nose or throat itchy, watery eyes due to hay fever temporarily reduces fever

Warnings:

hiatric 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. for more than 3 days for fever, unless directed by a doctor ask a doctor before use if you have daytime liver disease heart disease high blood pressure thyroid disease diabetes a cough that is accompanied by excessive phlegm(mucus) a persistent or chronic cough as occurs with smoking, asthma, or emphysema trouble urinating due to enlarged prostate gland nighttime liver disease glaucoma a cough that is accompanied by excessive phlegm (mucus) a breathing problem, persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland ask a doctor or pharmacist before use if you are daytime taking the blood thinning drug warfarin nighttime taking sedatives or tranquilizers taking bloodthinning drug warfarin stop use and ask a doctor if daytime symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. new symptoms occur redness or swelling is present nervousness, dizziness, or sleeplessness occur.these could be signs of a serious condition. nighttime pain or cough gets worse or lasts more than 5 days redness or swelling is present new symptoms occur cough comes back, occurs with rash or a persistent headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, daytime & nighttime ask a health professional before use. keep out of reach of children. daytime & nighttime 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.

Do Not Use:

Warnings liver warning: daytime & nighttime this product contains acetaminophen. severe liver damage may occur if you take more than 4 doses 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 daytime & nighttime 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: daytime & nighttime 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 daytime & nighttime 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. for more than 3 days for fever, unless directed by a doctor ask a doctor before use if you have daytime liver disease heart disease high blood pressure thyroid disease diabetes a cough that is accompanied by excessive phlegm(mucus) a persistent or chronic cough as occurs with smoking, asthma, or emphysema trouble urinating due to enlarged prostate gland nighttime liver disease glaucoma a cough that is accompanied by excessive phlegm (mucus) a breathing problem, persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema trouble urinating due to enlarged prostate gland ask a doctor or pharmacist before use if you are daytime taking the blood thinning drug warfarin nighttime taking sedatives or tranquilizers taking bloodthinning drug warfarin stop use and ask a doctor if daytime symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. new symptoms occur redness or swelling is present nervousness, dizziness, or sleeplessness occur.these could be signs of a serious condition. nighttime pain or cough gets worse or lasts more than 5 days redness or swelling is present new symptoms occur cough comes back, occurs with rash or a persistent headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, daytime & nighttime ask a health professional before use. keep out of reach of children. daytime & nighttime 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.

Dosage and Administration:

Directions daytime & nighttime take only as directed do not exceed 4 doses in a 24-hour period even if taking both daytime and nighttime, total limit per day is 4 doses per 24 hour period adults & children 12 years & over: take two (2) liquicaps with water every 4 hours children 4 to under 12 years consult a doctor children under 4 years: do not use

Stop Use:

Stop use and ask a doctor if daytime symptoms do not improve within 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. new symptoms occur redness or swelling is present nervousness, dizziness, or sleeplessness occur.these could be signs of a serious condition. nighttime pain or cough gets worse or lasts more than 5 days redness or swelling is present new symptoms occur cough comes back, occurs with rash or a persistent headache that lasts. these could be signs of a serious condition.

Package Label Principal Display Panel:

Principal display panel sanatos Â® multi symptom / multi sÃntomas daytime relief / alivio durante el dÃa acetaminophen, dextromethorphan hbr, phenylephrine hci/acetaminofÃ©n, dextrometorfano hbr, fenilefrina hci sore throat / dolor de garganta nasal congestion / congestiÃ³n nasal aches & fever / dolores y fiebre headache / dolor de cabeza cough / tos non-drowsy no causa sueÃ±o daytime liquicaps 12 liquicaps de dia sanatos Â® nighttime relief/alivio durante la noche acetaminophen, dextromethorphan hbr, doxylamine succinate acetaminofÃ©n, dextrometorfano hbr, sucinato de doxilamina sore throat / dolor de garganta aches & fever / dolor y fiebre runny nose / secreciÃ³n nasal sneezing / estornudos cough / tos nighttime liquicaps 12 liquicaps de noche sanatos 12-12

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.