Coricidin Hbp Cold And Flu
Acetaminophen And Chlorpheniramine Maleate
Proficient Rx Lp
Human Otc Drug
NDC 71205-312Coricidin Hbp Cold And Flu also known as Acetaminophen And Chlorpheniramine Maleate is a human otc drug labeled by 'Proficient Rx Lp'. National Drug Code (NDC) number for Coricidin Hbp Cold And Flu is 71205-312. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Coricidin Hbp Cold And Flu drug includes Acetaminophen - 325 mg/1 Chlorpheniramine Maleate - 2 mg/1 . The currest status of Coricidin Hbp Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 71205-312 |
| 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 Cold And Flu |
| 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: | Cold and Flu |
| 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 And Chlorpheniramine Maleate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Proficient Rx Lp |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet, Film Coated |
| 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
|
| 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 Oct, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 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, 2024 |
| 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: | Proficient Rx LP
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1112864
|
| 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. |
| UPC: | 0371205312107
|
| UPC stands for Universal Product Code. |
| UNII: | 362O9ITL9D
V1Q0O9OJ9Z
|
| 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: | Histamine H1 Receptor Antagonists [MoA]
Histamine-1 Receptor Antagonist [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 |
|---|
| 71205-312-10 | 1 BLISTER PACK in 1 CARTON (71205-312-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 01 Sep, 2019 | 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 tablet) purpose acetaminophen 325 mg pain reliever/ fever reducer chlorpheniramine maleate 2 mg antihistamine
Product Elements:
Coricidin hbp cold and flu acetaminophen and chlorpheniramine maleate starch, corn fd&c red no. 40 aluminum oxide anhydrous lactose magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified povidone, unspecified talc titanium dioxide acetaminophen acetaminophen chlorpheniramine maleate chlorpheniramine cf
Indications and Usage:
Uses ⢠temporarily relieves o minor aches and pains o headache o sneezing o runny nose ⢠temporarily reduces fever
Warnings:
Warnings liver warning this product contains acetaminophen. sever liver damage may occur if ⢠adult takes more than 12 tablets in 24 hours ⢠child takes more than 5 tablets in 24 hours ⢠taken with other drugs containing acetaminophen ⢠adult has 3 or more alcoholic drinks everyday 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. ask a doctor before use if the user has ⢠liver disease ⢠a breathing problem such as emphysema or chronic bronchitis ⢠glaucoma ⢠trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if the user is ⢠taking the blood thinning drug warfarin ⢠taking sedatives or tranquilizers when using this product ⢠excitability may occur, especially in children ⢠drowsiness may occur ⢠avoid alcoholic beverages ⢠al
Read more...cohol, sedatives and tranquilizers may increase drowsiness ⢠use caution when driving a motor vehicle or operating machinery stop use and ask a doctor if ⢠pain gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (adults) ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. 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 ⢠adult takes more than 12 tablets in 24 hours ⢠child takes more than 5 tablets in 24 hours ⢠taken with other drugs containing acetaminophen ⢠adult has 3 or more alcoholic drinks everyday 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. ask a doctor before use if the user has ⢠liver disease ⢠a breathing problem such as emphysema or chronic bronchitis ⢠glaucoma ⢠trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if the user is ⢠taking the blood thinning drug warfarin ⢠taking sedatives or tranquilizers when using this product ⢠excitability may occur, especially in children ⢠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 gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (adults) ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. 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 ⢠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 use more than directed (see overdose warning ) adults and children 12 years and over 2 tablets every 4 to 6 hours, not more than 12 tablets in 24 hours children 6 to under 12 years of age 1 tablet every 4 to 6 hours, not more than 5 tablets in 24 hours children under 6 years of age ask a doctor
Stop Use:
Stop use and ask a doctor if ⢠pain gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (adults) ⢠fever gets worse or lasts more than 3 days ⢠redness or swelling is present ⢠new symptoms occur
Overdosage:
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.
Package Label Principal Display Panel:
Principal display panel - 10 tablet carton 71205-312-10 coricidin hbp decongestant-free cold symptom relief for people with high blood pressure chlorpheniramine - antihistamine, acetaminophen - pain reliever/fever reducer see new warnings information cold & flu relieves: ⢠runny nose ⢠sneezing ⢠body aches and pains ⢠fever 10 tablets relabeled by: proficient rx lp thousand oaks, ca 91320 71205-312-10
Further Questions:
Questions or comments? call 1-800-317-2165