Cold Multi-symptom Night-time

Acetaminophen,chlorpheniramine Maleate, Dextromethorphan Hbr And Phenylephrine Hci

Allegiant Health
Human Otc Drug
NDC 69168-319

Cold Multi-symptom Night-time also known as Acetaminophen,chlorpheniramine Maleate, Dextromethorphan Hbr And Phenylephrine Hci is a human otc drug labeled by 'Allegiant Health'. National Drug Code (NDC) number for Cold Multi-symptom Night-time is 69168-319. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Cold Multi-symptom Night-time drug includes Acetaminophen - 325 mg/1 Chlorpheniramine Maleate - 2 mg/1 Dextromethorphan Hydrobromide - 10 mg/1 Phenylephrine Hydrochloride - 5 mg/1 . The currest status of Cold Multi-symptom Night-time drug is Active.

Drug Information:

Drug NDC:	69168-319
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:	Cold Multi-symptom Night-time
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	Cold Multi-symptom
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix:	Night-time
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
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,chlorpheniramine Maleate, Dextromethorphan Hbr And Phenylephrine Hci
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Allegiant Health
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 CHLORPHENIRAMINE MALEATE - 2 mg/1 DEXTROMETHORPHAN HYDROBROMIDE - 10 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:	23 Dec, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	18 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:	Allegiant Health
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1086991
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:	362O9ITL9D V1Q0O9OJ9Z 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] Histamine H1 Receptor Antagonists [MoA] Histamine-1 Receptor Antagonist [EPC] 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
69168-319-86	12 TABLET in 1 BLISTER PACK (69168-319-86)	23 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.

Other medicines with the same generic name

Cold Multi-symptom Night-time

Acetaminophen & more..

Tablet
Allegiant Health
NDC: 69168-319

Purpose:

Purpose pain reliever/fever reducer antihistamine cough suppressant nasal decongestant

Product Elements:

Cold multi-symptom night-time acetaminophen,chlorpheniramine maleate, dextromethorphan hbr and phenylephrine hci acetaminophen acetaminophen chlorpheniramine maleate chlorpheniramine dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine silicon dioxide starch, corn croscarmellose sodium fd&c blue no. 1 magnesium stearate cellulose, microcrystalline povidone stearic acid titanium dioxide hypromellose, unspecified polyethylene glycol, unspecified crospovidone az319

Indications and Usage:

Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sneezing and runny nose sinus congestion and pressure helps clear nasal passages relieves cough to help you sleep temporarily reduces fever

Warnings:

prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric or emotional conditions, or parkinsonâs 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, 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 taking sedatives or tranquilizers when using this product do not exceed recommended dosage. excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs 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

Do Not Use:

Warnings liver warning/allergy alert 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 with other drugs containing acetaminophen 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 immediately sore throat warning 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 parkinsonâs 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, 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 taking sedatives or tranquilizers when using this product do not exceed recommended dosage. excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if nervousness, dizziness or sleeplessness occurs 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

When Using:

When using this product do not exceed recommended dosage. excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery

Dosage and Administration:

Directions do not take more than directed (see overdose warnings) adults and children 12 years and over: take 2 caplets every 4 hours swallow whole; do not crush, chew or dissolve do not take more than a total of 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 occurs 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:

Package/label principal display panel cold multi-symptom cold multi-symptom

Further Questions:

Questions or comments? call toll free 1-888-952-0050 monday through friday

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.