Coricidin Hbp Maximum Strength Cold And Flu Day And Night
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Doxylamine Succinate
Bayer Healthcare Llc.
Human Otc Drug
NDC 11523-0100Coricidin Hbp Maximum Strength Cold And Flu Day And Night also known as Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Doxylamine Succinate is a human otc drug labeled by 'Bayer Healthcare Llc.'. National Drug Code (NDC) number for Coricidin Hbp Maximum Strength Cold And Flu Day And Night is 11523-0100. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Coricidin Hbp Maximum Strength Cold And Flu Day And Night drug includes . The currest status of Coricidin Hbp Maximum Strength Cold And Flu Day And Night drug is Active.
Drug Information:
| Drug NDC: | 11523-0100 |
| 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 Maximum Strength Cold And Flu Day And Night |
| 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 Hydrobromide, Guaifenesin, Doxylamine Succinate |
| 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: | 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 Jul, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 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: | Bayer HealthCare LLC.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 707195
1426334
2612689
|
| 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 |
|---|
| 11523-0100-1 | 1 KIT in 1 BLISTER PACK (11523-0100-1) * 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 01 Jul, 2022 | 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:
Purpose
Product Elements:
Coricidin hbp maximum strength cold and flu day and night acetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate coricidin hbp maximum strength cold and flu day acetaminophen, guaifenesin mica acetaminophen acetaminophen lecithin, soybean shellac sorbitol titanium dioxide water sodium hydroxide sorbitan ferrosoferric oxide potassium aluminum disilicate povidone fd&c yellow no. 6 medium-chain triglycerides propylene glycol polyethylene glycol, unspecified guaifenesin guaifenesin gelatin glycerin oblong chbpd coricidin hbp maximum strength cold and flu night acetaminophen, doxylamine succinate, dextromethorphan hydrobromide, doxylamine succinate doxylamine succinate doxylamine lecithin, soybean shellac sorbitan medium-chain triglycerides povidone sodium hydroxide sorbitol soybean oil titanium dioxide acetaminophen acetaminophen propylene glycol water fd&c blue no. 1 polyethylene glycol, unspecified dextromethorphan hydrobromide dextromethorphan d&c yellow no. 10 gelatin glycerin chbpn
Indications and Usage:
Uses uses · temporarily relieves these symptoms due to a cold or flu: · minor aches and pains · headache · sore throat · helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive · temporarily reduces fever
Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains · headache · cough sore throat · runny nose · sneezing temporarily reduces fever
Warnings:
Warnings warnings liver warning: this product contains acetaminophen. 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 allergy alert: acetaminophen may cause severe skin or severe allergic reactions. symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock if a skin or general allergic 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 do not use â with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist â if you have ever had an allergic reac
Read more...tion to this product or any of its ingredients â in children under 12 years of age aska a doctor ask a doctor before use if you have â liver disease â persistent or chronic cough such as occurs with smoking, asthma,chronic bronchitis, or emphysema â cough that occurs with excess phelgm ask a doctor or pharmacist ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin stop use 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 rash or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children keep out of reach of children. 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.
Liver warning liver warning : this product contains acetaminophen. 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 allergy alert: acetaminophen may cause severe skin or severe allergic reactions. symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock if a skin or general allergic 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:
Warnings warnings liver warning: this product contains acetaminophen. 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 allergy alert: acetaminophen may cause severe skin or severe allergic reactions. symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock if a skin or general allergic 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 do not use â with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist â if you have ever had an allergic reaction to this product or any of its ingredients â in children under 12 years of age aska a doctor ask a doctor before use if you have â liver disease â persistent or chronic cough such as occurs with smoking, asthma,chronic bronchitis, or emphysema â cough that occurs with excess phelgm ask a doctor or pharmacist ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin stop use 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 rash or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children keep out of reach of children. 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.
Liver warning liver warning : this product contains acetaminophen. 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 allergy alert: acetaminophen may cause severe skin or severe allergic reactions. symptoms may include: · skin reddening · blisters · rash · hives · facial swelling · asthma (wheezing) · shock if a skin or general allergic 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.
When Using:
When using this product â may cause marked drowsiness â avoid alcoholic beverages â alcohol, sedatives, and tranquilizers may increase drowsiness â be careful when driving a motor vehicle or operating machinery â excitability may occur, especially in children
Dosage and Administration:
Directions directions · do not take more than the recommended dose · do not take the day and night products at the same time; wait 4 hours after taking the last night dose before taking the day product. · adults and children 12 years and over: take 2 capsules with water every 4 hours. do not exceed 6 capsules in 12 hours or as directed by a doctor. · children under 12 years of age: do not use
Directions · do not take more than the recommended dose · do not take the day and night products at the same time; wait 4 hours after taking the last day dose before taking the night product. · adults and children 12 years and over: take 2 capsules with water every 4 hours. do not exceed 4 capsules in 12 hours or as directed by a doctor. · children under 12 years of age: do not use
Stop Use:
Stop use 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 rash or headache that lasts. 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 rash or headache that lasts. these could be signs of a serious condition
Package Label Principal Display Panel:
Coricidin® hbp cold relief for people with high blood pressureÆ maximum strength cold & flu day acetaminophen - pain reliever/fever reducer guaifenesin - expectorant relieves body aches & pains headache chest congestion sore throat fever Æ decongestant free 16 liquid gels (liquid filled capsules) cold & flu night doxylamine succinate - antihistamine acetaminophen - pain reliever/fever reducer dextromethorphan hbr- cough suppressant relieves body aches & pains headache runny nose & sneezing cough sore throat fever Æ decongestant free 8 liquid gels (liquid filled capsules) coricidin combo-22
Further Questions:
Questions or comments? questions or comments? 1-800-317-2165 (mon-fri 9am -5pm est)
Questions or comments?1-800-317-2165 (mon-fri 9am -5pm est)