Maximum Strength Daytime Nighttime Cold And Flu
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl
Cvs Pharmacy, Inc.
Human Otc Drug
NDC 69842-451Maximum Strength Daytime Nighttime Cold And Flu also known as Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl is a human otc drug labeled by 'Cvs Pharmacy, Inc.'. National Drug Code (NDC) number for Maximum Strength Daytime Nighttime Cold And Flu is 69842-451. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Maximum Strength Daytime Nighttime Cold And Flu drug includes . The currest status of Maximum Strength Daytime Nighttime Cold And Flu drug is Active.
Drug Information:
| Drug NDC: | 69842-451 |
| 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: | Maximum Strength Daytime Nighttime Cold And Flu |
| 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, Guaifenesin, Phenylephrine Hcl Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Cvs Pharmacy, Inc. |
| 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: | 10 Jul, 2021 |
| 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: | CVS Pharmacy, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1297288
1656815
1657147
|
| 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. |
| UPC: | 0050428298398
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 69842-451-24 | 1 BLISTER PACK in 1 CARTON (69842-451-24) / 1 KIT in 1 BLISTER PACK * 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69842-094-16) * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69842-382-08) | 10 Jul, 2021 | 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:
Purposes daytime cold & flu pain reliever/fever reducer cough suppressant expectorant nasal decongestant purposes nighttime cold & flu pain reliever/fever reducer cough suppressant antihistamine nasal decongestant
Product Elements:
Maximum strength daytime nighttime cold and flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl maximum strength daytime cold and flu acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl fd&c yellow no. 6 sorbitol povidone polyethylene glycol, unspecified propylene glycol water acetaminophen acetaminophen shellac titanium dioxide guaifenesin guaifenesin gelatin phenylephrine hydrochloride phenylephrine dextromethorphan hydrobromide dextromethorphan glycerin 78 maximum strength nighttime cold and flu acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl propylene glycol titanium dioxide phenylephrine hydrochloride phenylephrine gelatin polyethylene glycol, unspecified shellac glycerin povidone sorbitol acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine water fd&c blue no. 1 72
Indications and Usage:
Uses temporarily relieves these common cold and flu symptoms: sinus congestion and pressure cough minor aches and pains headache nasal congestion sore throat runny nose and sneezing ( nighttime only ) itchy, watery eyes due to hay fever ( nighttime only ) itching of the nose or throat ( nighttime only ) helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ( daytime only ) controls cough to help you get to sleep temporarily reduces fever
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 12 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product 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 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 liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 12 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product 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 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 do not use more than directed excitability may occur, especially in children ( nighttime only ) marked drowsiness may occur ( nighttime only ) alcohol, sedatives, and tranquilizers may increase drowsiness ( nighttime only ) avoid alcoholic drinks ( nighttime only ) be careful when driving a motor vehicle or operating machinery ( nighttime only )
Dosage and Administration:
Directions do not take more than directed (see overdose warning) do not take more than 12 softgels in any 24-hour period adults and children 12 years of age and over: take 2 softgels every 4 hours children under 12 years of age: do not use
Stop Use:
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur 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 fever, rash, or headache that lasts. these could be signs of a serious condition.
Package Label Principal Display Panel:
Maximum strength daytime and nightime - cold and dlu - cvs -24s carton
Further Questions:
Questions? call 1-877-290-4008