Severe Daytime Nighttime Cold And Flu Relief Max Strength
Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl, Guaifenesin
Yet Health Group Llc
Human Otc Drug
NDC 81179-804Severe Daytime Nighttime Cold And Flu Relief Max Strength also known as Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl, Guaifenesin is a human otc drug labeled by 'Yet Health Group Llc'. National Drug Code (NDC) number for Severe Daytime Nighttime Cold And Flu Relief Max Strength is 81179-804. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Severe Daytime Nighttime Cold And Flu Relief Max Strength drug includes . The currest status of Severe Daytime Nighttime Cold And Flu Relief Max Strength drug is Active.
Drug Information:
| Drug NDC: | 81179-804 |
| 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: | Severe Daytime Nighttime Cold And Flu Relief Max Strength |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Severe Daytime Nighttime Cold And Flu Relief |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Max Strength |
| 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, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl, Guaifenesin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Yet Health Group 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: | 02 Sep, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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: | YET HEALTH GROUP LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1297288
1656815
2570282
|
| 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 |
|---|
| 81179-804-02 | 1 BOTTLE in 1 CARTON (81179-804-02) / 1 KIT in 1 BOTTLE * 1 CAPSULE, LIQUID FILLED in 1 BOTTLE (81179-004-00) * 1 CAPSULE, LIQUID FILLED in 1 BOTTLE (81179-008-00) | 02 Sep, 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:
Nighttime severe cold & flu purpose pain reliever/fever reducer cough suppressant antihistamine nasal decongestant
Daytime severe cold & flu purpose pain reliever/fever reducer cough suppressant expectorant nasal decongestant
Product Elements:
Severe daytime nighttime cold and flu relief max strength acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl, guaifenesin severe nighttime cold and flu relief max strength acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl sodium hydroxide water propylene glycol povidone fd&c blue no. 1 gelatin glycerin sorbitol polyethylene glycol 1000000 polysorbate 80 titanium dioxide acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine d&c yellow no. 10 sorbitan phenylephrine hydrochloride phenylephrine is5 severe daytime cold and flu relief max strength acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl phenylephrine hydrochloride phenylephrine sorbitan guaifenesin guaifenesin sorbitol water propylene glycol polyethylene glycol, unspecified fd&c yellow no. 6 povidone, unspecified gelatin glycerin polysorbate 80 titanium dioxide acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan is4
Indications and Usage:
Nighttime severe cold & flu uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion and pressure cough due to minor throat and bronchial irritation cough to help you sleep minor aches and pains headache fever sore throat runny nose and sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage
Daytime severe cold & flu uses temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion and pressure cough due to minor throat and bronchial irritation minor aches and pains headache fever sore throat reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage helps loosen phlegm (musus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings:
Warnings liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 8 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day 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 8 softgels in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day 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:
Nighttime severe cold & flu when using this product do not exceed recommended dosage excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness
Daytime severe cold & flu when using this product do not use more than directed.
Dosage and Administration:
Nighttime severe cold & flu directions take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Daytime severe cold & flu directions take only as directed do not exceed 8 softgels per 24 hrs adults & children 12 yrs & over take 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use
Stop Use:
Nighttime severe cold & flu stop use and ask a doctor if you gets nervous, dizzy or sleepless 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 rash or headache that lasts. these could be signs of a serious condition.
Daytime severe cold & flu stop use and ask a doctor if you get nervous, dizzy or sleepless 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 rash or headache that lasts. these could be signs of a serious condition.
Package Label Principal Display Panel:
01b uc_b-b_daytime-nighttime severe cold-flu relief_80-40
Further Questions:
Questions? call toll-free 1-844-735-0202