Coricidin Hbp Day And Night

Dextromethorphan Hydrobromide, Guaifenesin, Acetaminophen, Chlorpheniramine Maleate

Bayer Healthcare Llc.
Human Otc Drug
NDC 11523-4765

Coricidin Hbp Day And Night also known as Dextromethorphan Hydrobromide, Guaifenesin, Acetaminophen, Chlorpheniramine Maleate is a human otc drug labeled by 'Bayer Healthcare Llc.'. National Drug Code (NDC) number for Coricidin Hbp Day And Night is 11523-4765. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Coricidin Hbp Day And Night drug includes . The currest status of Coricidin Hbp Day And Night drug is Active.

Drug Information:

Drug NDC:	11523-4765
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:	Coricidin Hbp Day And Night
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	Coricidin Hbp
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix:	Day and Night
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:	Dextromethorphan Hydrobromide, Guaifenesin, Acetaminophen, Chlorpheniramine Maleate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Bayer Healthcare Llc.
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:
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:	28 Aug, 2009
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	09 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:	Bayer HealthCare LLC.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1098496 1111663 1250983
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
11523-4765-1	1 KIT in 1 CARTON (11523-4765-1) * 2 BLISTER PACK in 1 CARTON (11523-4221-1) / 8 CAPSULE, GELATIN COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON (11523-4111-1) / 4 TABLET in 1 BLISTER PACK	28 Aug, 2009	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

Coricidin Hbp Day And Night

Dextromethorphan Hydrobromide & more..

Kit
Bayer HealthCare LLC.
NDC: 11523-4765

Purpose:

Active ingredients (in each softgel) purpose dextromethorphan hydrobromide 10 mg cough suppressant guaifenesin 200 mg expectorant

Active ingredients (in each tablet) purpose acetaminophen 500 mg pain reliever/fever reducer chlorpheniramine maleate 2 mg antihistamine dextromethorphan hydrobromide 15 mg cough suppressant

Product Elements:

Coricidin hbp day and night dextromethorphan hydrobromide, guaifenesin, acetaminophen, chlorpheniramine maleate coricidin hbp day dextromethorphan hydrobromide and guaifenesin fd&c blue no. 1 fd&c red no. 40 gelatin polyethylene glycol 400 povidone propylene glycol sorbitol dextromethorphan hydrobromide dextromethorphan guaifenesin guaifenesin c;day coricidin hbp night acetaminophen, chlorpheniramine maleate and dextromethorphan hydrobromide carnauba wax fd&c red no. 40 aluminum oxide hypromelloses lactose magnesium stearate cellulose, microcrystalline propylene glycol povidone stearic acid titanium dioxide acetaminophen acetaminophen chlorpheniramine maleate chlorpheniramine dextromethorphan hydrobromide dextromethorphan c;night

Indications and Usage:

Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Uses temporarily relieves minor aches and pains headache cough runny nose sneezing temporarily reduces fever

Warnings:

Warnings 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. ask a doctor before use if you have cough that occurs with excessive phlegm (mucus) persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with fever, rash or persistent headache. these could be signs of a serious condition. if pregnant or breast-feeding, 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. abuse of this product can lead to serious injury.

tis, or emphysema ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if pain 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 a 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 out of reach of children. abuse of this product can lead to serious injury. overdose warning taking more than the recommended dose may cause liver damage. 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 children even if you do not notice any signs or symptoms.

Do Not Use:

Warnings liver warning this product contains acetaminophen. sever liver damage may occur if you take more than 4 tablets in 12 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product do not use with any other drug containing acetaminophen (prescription or non prescription). 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 a maoi, ask a doctor or pharmacist before taking this product. ask a doctor before use if you have liver disease glaucoma trouble urinating due to an enlarged prostate gland cough that occurs with excessive phlegm (mucus) a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if pain 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 a 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 out of reach of children. abuse of this product can lead to serious injury. overdose warning taking more than the recommended dose may cause liver damage. 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 children even if you do not notice any signs or symptoms.

When Using:

When using this product excitability may occur, especially in children marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery

Dosage and Administration:

Directions do not exceed recommended dose do not take the day and night products at the same time; wait 4 hours after the last night dose before starting day product adults and children 12 years and over: 1 or 2 softgels every 4 hours, not more than 6 softgels in 12 hours children under 12 years of age: ask a doctor

Directions do not use more than directed (see overdose warning ) do not take the day and night products at the same time; wait 4 hours after the last day dose before starting night product adults and children 12 years and over: 2 tablets at bedtime and every 6 hours if needed, while symptoms persist, not more than 4 tablets in a 12 hour period children under 12 years of age: ask a doctor

Stop Use:

Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with fever, rash or persistent headache. these could be signs of a serious condition.

Stop use and ask a doctor if pain 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 a rash or headache that lasts. these could be signs of a serious condition.

Package Label Principal Display Panel:

Principal display panel - kit carton dual formula pack coricidin Â® hbp decongestant-free cold relief for people with high blood pressure day multi-symptom cold guaifenesin - expectorant dextromethorphan hbr - cough suppressant day relieves: chest congestion cough 16 day softgels night chlorpheniramine maleate - antihistamine, dextromethorphan hbr - cough suppressant, acetaminophen - pain reliever/fever reducer see new warnings information night relieves: runny nose & sneezing cough â¢ body aches fever 8 night tablets dn

Further Questions:

Questions or comments? call 1-800-317-2165 (mon-fri 9am-5pm est)

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.