Equate Health Non Drowsy Day Cold And Flu Plus And Nighttime Cold And Flu Plus
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride
Wal-mart Stores Inc
Human Otc Drug
NDC 79903-133Equate Health Non Drowsy Day Cold And Flu Plus And Nighttime Cold And Flu Plus also known as Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride is a human otc drug labeled by 'Wal-mart Stores Inc'. National Drug Code (NDC) number for Equate Health Non Drowsy Day Cold And Flu Plus And Nighttime Cold And Flu Plus is 79903-133. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Equate Health Non Drowsy Day Cold And Flu Plus And Nighttime Cold And Flu Plus drug includes . The currest status of Equate Health Non Drowsy Day Cold And Flu Plus And Nighttime Cold And Flu Plus drug is Active.
Drug Information:
| Drug NDC: | 79903-133 |
| 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: | Equate Health Non Drowsy Day Cold And Flu Plus And Nighttime Cold And Flu Plus |
| 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, Doxylamine Succinate, Phenylephrine Hydrochloride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Wal-mart Stores 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: | |
| 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: | 11 Aug, 2022 |
| 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: | Wal-Mart Stores Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1086997
1297288
1297404
|
| 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 |
|---|
| 79903-133-20 | 1 KIT in 1 CARTON (79903-133-20) * 1 BLISTER PACK in 1 CARTON / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 1 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 11 Aug, 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:
Purposes day cold & flu formula pain reliever/fever reducer cough suppressant nasal decongestant night cold & flu formula pain reliever/fever reducer cough suppressant antihistamine nasal decongestant
Product Elements:
Equate health non drowsy day cold and flu plus and nighttime cold and flu plus acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride equate health day cold and flu plus acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin polyethylene glycol 400 povidone propylene glycol sorbitol titanium dioxide phenylephrine hydrochloride phenylephrine acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan 512;a09 equate health nighttime cold and flu plus acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride d&c yellow no. 10 fd&c blue no. 1 gelatin glycerin polyethylene glycol 400 povidone propylene glycol sorbitol sorbitan sodium hydroxide titanium dioxide acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine doxylamine succinate doxylamine 116;a07
Indications and Usage:
Uses day cold & flu formula temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough sore throat nasal and sinus congestion temporarily reduces fever night cold & flu formula pain reliever/fever reducer cough suppressant antihistamine nasal decongestant
Warnings:
Undefined liver warning day cold & flu formula these products contain acetaminophen. severe liver damage may occur if you take more than 10 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 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. 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. nighttime cold & flu formula liver warning these products contain acetaminophen. severe liver damage may occur if you take more than 10 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 sore thro
Read more...at 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. 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 to sedate children. do not use day cold & flu formula with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age nighttime cold & flu formula with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age ask a doctor before use if you have daytime cold & flu formula liver disease heart disease high blood pressure thyroid disease diabetes cough with excessive phlegm (mucus) difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema nighttime cold & flu formula liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema daytime cold & flu formula ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. nighttime cold & flu formula taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product daytime cold & flu formula when using this product do not exceed recommended dosage nighttime cold & flu formula do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children stop use and ask a doctor if daytime cold & flu formula pain, cough, or nasal congestion 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. nervousness, dizziness, or sleeplessness occurs nighttime cold &flu formula pain, cough, or nasal congestion 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. nervousness, dizziness, or sleeplessness occurs if pregnant or breast-feeding, ask a health professional before use. if pregnant or breast-feeding, ask a health professional before use.
Do Not Use:
Undefined liver warning day cold & flu formula these products contain acetaminophen. severe liver damage may occur if you take more than 10 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 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. 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. nighttime cold & flu formula liver warning these products contain acetaminophen. severe liver damage may occur if you take more than 10 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 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. 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 to sedate children. do not use day cold & flu formula with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age nighttime cold & flu formula with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the maoi drug. if you do not know if your prescription drug contains an maoi, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age ask a doctor before use if you have daytime cold & flu formula liver disease heart disease high blood pressure thyroid disease diabetes cough with excessive phlegm (mucus) difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema nighttime cold & flu formula liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema daytime cold & flu formula ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. nighttime cold & flu formula taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product daytime cold & flu formula when using this product do not exceed recommended dosage nighttime cold & flu formula do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children stop use and ask a doctor if daytime cold & flu formula pain, cough, or nasal congestion 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. nervousness, dizziness, or sleeplessness occurs nighttime cold &flu formula pain, cough, or nasal congestion 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. nervousness, dizziness, or sleeplessness occurs if pregnant or breast-feeding, ask a health professional before use. if pregnant or breast-feeding, ask a health professional before use.
When Using:
When using this product daytime cold & flu formula when using this product do not exceed recommended dosage nighttime cold & flu formula do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
Dosage and Administration:
Directions day cold & flu formula do not take more than the recommended dose adults and children 12 years and over: take 2 softgels with water every 4 hours. do not exceed 10 softgels in 24 hours or as directed by a doctor. children under 12 years: do not use nighttime cold & flu formula do not take more than the recommended dose adults and children 12 years and over: take 2 softgels with water every 4 hours. do not exceed 10 softgels in 24 hours or as directed by a doctor. children under 12 years: do not use
Stop Use:
Stop use and ask a doctor if daytime cold & flu formula pain, cough, or nasal congestion 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. nervousness, dizziness, or sleeplessness occurs nighttime cold &flu formula pain, cough, or nasal congestion 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. nervousness, dizziness, or sleeplessness occurs
Package Label Principal Display Panel:
Principal display panel equate non-drowsy day cold & flu formula and nighttime cold & flu formula 20ct compare to the active ingredients in alka-seltzer plus® day and night cold and flu formula* non-drowsy day cold & flu formula acetaminophen- pain reliever; fever reducer dextromethorphan hbr - cough suppressant phenylephrine hci - nasal decongestant relieves: nasal congestion; cough; headache & body ache; sore throat; sinus pressure 12 softgels nighttime cold & flu formula acetaminophen- pain reliever; fever reducer dextromethorphan hbr - cough suppressant doxylamine succinate - antihistamine phenylephrine hci - nasal decongestant relieves: nasal congestion; cough; headache & body ache; sore throat; runny nose 8 softgels this product is packaged in a child-resistant and tamper-evident package. use only if blisters are intact *this product is not manufactured or distributed by bayer healthcare llc, owner of the registered trademark alka-seltzer plus® day and night cold and flu formula carton
Further Questions:
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