Maximum Strength Daytime Nighttime Sinus Relief
Acetaminophen Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl And Acetaminophen Dextromethorphan Hbr Doxylamine Succinate Phenylephrine Hcl
Cvs Pharmacy, Inc.
Human Otc Drug
NDC 69842-442Maximum Strength Daytime Nighttime Sinus Relief also known as Acetaminophen Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl And 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 Sinus Relief is 69842-442. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Maximum Strength Daytime Nighttime Sinus Relief drug includes . The currest status of Maximum Strength Daytime Nighttime Sinus Relief drug is Active.
Drug Information:
| Drug NDC: | 69842-442 |
| 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 Sinus Relief |
| 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 And 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: | 22 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. |
| 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 |
|---|
| 69842-442-24 | 1 BLISTER PACK in 1 CARTON (69842-442-24) / 1 KIT in 1 BLISTER PACK * 16 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69842-617-16) * 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (69842-290-08) | 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 sinus relief pain reliever cough suppressant expectorant nasal decongestant purposes nighttime sinus relief pain reliever cough suppressant antihistamine nasal decongestant
Product Elements:
Maximum strength daytime nighttime sinus relief acetaminophen dextromethorphan hbr guaifenesin phenylephrine hcl and acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hcl maximum strength daytime sinus relief acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl dextromethorphan hydrobromide dextromethorphan glycerin povidone propylene glycol shellac sorbitol titanium dioxide phenylephrine hydrochloride phenylephrine gelatin water guaifenesin guaifenesin fd&c yellow no. 6 polyethylene glycol, unspecified acetaminophen acetaminophen pc26 maximum strength nighttime sinus relief acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl sorbitol titanium dioxide phenylephrine hydrochloride phenylephrine povidone water acetaminophen acetaminophen shellac dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine propylene glycol glycerin fd&c blue no. 1 gelatin polyethylene glycol, unspecified 116
Indications and Usage:
Uses temporarily relieves: cough minor aches and pains headache nasal congestion sinus congestion and pressure runny nose and sneezing ( 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 ) temporarily promotes nasal and/or sinus drainage
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 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.
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 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.
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 older: take 2 softgels every 4 hours children under 12 years of age: do not use
Stop Use:
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 )
Package Label Principal Display Panel:
Maximum strength day time and nightime sinus relief - cvs -24s carton
Further Questions:
Questions? call 1-877-290-4008