Daytime Nighttime Severe Cold And Flu

Acetaminophen Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl Doxylaminesucinate

Family Dollar (family Wellness)
Human Otc Drug
NDC 55319-813

Daytime Nighttime Severe Cold And Flu also known as Acetaminophen Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl Doxylaminesucinate is a human otc drug labeled by 'Family Dollar (family Wellness)'. National Drug Code (NDC) number for Daytime Nighttime Severe Cold And Flu is 55319-813. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Daytime Nighttime Severe Cold And Flu drug includes . The currest status of Daytime Nighttime Severe Cold And Flu drug is Active.

Drug Information:

Drug NDC:	55319-813
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:	Daytime Nighttime Severe 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 Doxylaminesucinate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Family Dollar (family Wellness)
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:	31 Jul, 2019
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	31 Jul, 2025
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:	10 May, 2026
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:	Family Dollar (FAMILY WELLNESS)
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1369842 1431245 1860085
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:	0032251525063
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
55319-813-16	1 KIT in 1 KIT (55319-813-16) * 237 mL in 1 BOTTLE * 237 mL in 1 BOTTLE	31 Jul, 2019	31 Jul, 2025	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.

Other medicines with the same generic name

Daytime Nighttime Severe Cold And Flu

Acetaminophen Dextromethorphan Hbr Guaifenesin Phenylephrine Hcl Doxylaminesucinate & more..

Kit
Family Dollar (FAMILY WELLNESS)
NDC: 55319-813

Purpose:

Purposes for day time pain reliever/fever reducer cough suppressant expectorant nasal decongestant

Purpose for night time pain reliever/fever reducer cough suppressant antihistamine nasal decongestant

Product Elements:

Daytime nighttime severe cold and flu acetaminophen dextromethorphan hbr guaifenesin phenylephrine hcl doxylaminesucinate daytime severe cold and flu acetaminophen dextromethorphan hbr guaifenesin phenylephrine hcl acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine guaifenesin guaifenesin anhydrous citric acid fd&c yellow no. 6 propylene glycol water trisodium citrate dihydrate glycerin saccharin sodium sodium benzoate sodium chloride sorbitol sucralose xanthan gum nighttime severe cold and flu acetaminophen dextromethorphan hbr doxylamine succinate phenylephrine hcl acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine phenylephrine hydrochloride phenylephrine anhydrous citric acid fd&c blue no. 1 fd&c red no. 40 glycerin propylene glycol water sodium benzoate trisodium citrate dihydrate saccharin sodium sodium chloride sorbitol sucralose xanthan gum

Indications and Usage:

Uses daytime temporarily relieves common cold and flu symptoms nasal congestion sinus congestion and pressure minor aches and pain headache fever sore throat reduces swelling of nasal passages cough due to minor throat and bronchial irritation temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make cough more productive nighttime temporarily relieves these common cold/flu symptoms` nasal congestion sore throat headache sinus congestion and pressure minor aches and pains runny nose and sneezing cough due to minor throat and bronchial irritation temporarily reduces fever cough to help you sleep swelling of nasal passage temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage

Warnings:

duct 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 daytime nighttime 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 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 child's prescription drug contains an maoi, ask a doctor or pharmacist before giving this product. ask a doctor before use if you have daytime liver disease heart disease high blood pressure thyroid disease diabetes a sodium-restricted diet trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) nighttime liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet ask a doctor or pharmacist before use if you are daytime taking the blood thinning drug warfarin. nighttime taking sedatives or tranquilizers taking the blood thinning drug warfarin when using this product daytime do not take more than directed. nighttime do not take more than directed 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 stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult) 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. nighttime 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 rash, or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. daytime nighttime taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center(1-800-222-1222) right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do Not Use:

Warnings daytime liver warning: this product contains acetaminophen. severe liver damage may occur if: adult takes more than 4 doses (30 ml each) of acetaminophen in 24 hours, which is the maximum daily amount child takes more than 4 doses (15 ml each) in 24 hours taken with other drugs containing acetaminophen adult has 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. nighttime liver warning: this product contains acetaminophen. severe liver damage may occur if you take: more than 4,000 mg of acetaminophen in 24 hours 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 daytime nighttime 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 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 child's prescription drug contains an maoi, ask a doctor or pharmacist before giving this product. ask a doctor before use if you have daytime liver disease heart disease high blood pressure thyroid disease diabetes a sodium-restricted diet trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) nighttime liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to enlarged prostate gland a sodium-restricted diet ask a doctor or pharmacist before use if you are daytime taking the blood thinning drug warfarin. nighttime taking sedatives or tranquilizers taking the blood thinning drug warfarin when using this product daytime do not take more than directed. nighttime do not take more than directed 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 stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult) 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. nighttime 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 rash, or headache that lasts. these could be signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. daytime nighttime taking more than the recommended dose (overdose) may cause liver damage. in case of overdose, get medical help or contact a poison control center(1-800-222-1222) right away. quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

When Using:

When using this product daytime do not take more than directed. nighttime do not take more than directed 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

Dosage and Administration:

Directions daytime do not take more than directed (see overdose warning) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided. do not use any other dosing device. keep dosing cup with product ml= milliliter adults and children 12 years and over 30 ml every 4 hours children 6 to under 12 years 15 ml every 4 hours children 4 to under 6 years ask a doctor children under 4 years do not use nighttime take only as directed (see overdose warning) do not exceed 4 doses per 24 hours measure only with dosing cup provided. do not use any other dosing device. ml= milliliter keep dosing cup with product adults and children 12 years and over: 30 ml every 4 hours children under 12 years of age: do not use when using other daytime or nighttime products, carefully read each label or ensure correct dosing

Stop Use:

Stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur pain, nasal congestion, or cough gets worse, or lasts more than 5 days(children) or 7 days (adult) 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. nighttime 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 rash, or headache that lasts. these could be signs of a serious condition.

Package Label Principal Display Panel:

Principal display panel compare to the active ingredients in vicksÂ® dayquilÂ® and nyquilÂ® severe cold & flu* severe cold & flu relief daytime acetaminophen (pain reliever / fever reducer) dextromethorphan hbr (cough suppressant) guaifenesin (expectorant) phenylephrine hci (nasal decongestant) relieves headache, fever, sore throat, minor aches & pains nasal/sinus congestion & sinus pressure cough chest congestion for ages 6 years and over max strength non-drowsy alcohol free when using other daytime or nighttime products, carefully read each label to ensure correct dosing night time acetaminophen (pain reliever / fever reducer) dextromethorphan hbr (cough suppressant) doxylamine succinate (antihistamine) phenylephrine hcl (nasal decongestant) relieves headache, fever, sore throat, minor aches & pain nasal/sinus congestion & sinus pressure sneezing runny nose cough max strength alcohol free fl oz (ml) berry flavor *this product is not manufactured or distributed by the procter & gamble company. vicksÂ®, dayquilÂ® and nyquilÂ® are registered trademarks of the procter & gamble company. tamper evident: do not use if printed safety seal around dosage cup or under cap is broken or missing. distributed by midwood brands, llc 500 volvo parkway chesapeake, va 23320

Product label family wellness daytime nigttime severe cold and flu relief acetaminophen 325 mg, dextromethorphan hbr 10 mg, guaifenesin 200 mg phenylephrine hcl.5mg, acetaminophen 650 mg, dextromethorphan hbr 20 mg, doxylamine succinate 12.5 mg, phenylephrine hcl 10 mg

Further Questions:

Questions or comments? call 1-877-753-3935 monday-friday 9am-5pm est

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.