Daytime Nighttime Cold/flu

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Diphenhydramine Hci

Cvs Pharmacy
Human Otc Drug
NDC 59779-686

Daytime Nighttime Cold/flu also known as Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Diphenhydramine Hci is a human otc drug labeled by 'Cvs Pharmacy'. National Drug Code (NDC) number for Daytime Nighttime Cold/flu is 59779-686. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Daytime Nighttime Cold/flu drug includes . The currest status of Daytime Nighttime Cold/flu drug is Active.

Drug Information:

Drug NDC:	59779-686
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 Cold/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, Phenylephrine Hcl, Diphenhydramine Hci
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Cvs Pharmacy
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, 2016
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	10 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:	CVS Pharmacy
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1113705 1298348 1803669
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:	0050428560013 0050428377970 0050428253335
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
59779-686-16	1 KIT in 1 KIT (59779-686-16) * 245 mL in 1 BOTTLE, PLASTIC (59779-691-08) * 245 mL in 1 BOTTLE, PLASTIC (59779-693-08)	31 Jul, 2016	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.

Other medicines with the same generic name

Daytime Nighttime Cold/flu

Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Diphenhydramine Hci

Kit
CVS Pharmacy
NDC: 59779-686

Purpose:

Purpose for daytime pain reliever/fever reducer cough suppressant nasal decongestant

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

Product Elements:

Daytime nighttime cold/flu acetaminophen, dextromethorphan hbr, phenylephrine hcl, diphenhydramine hci daytime cold and flu acetaminophen, dextromethorphan hbr, phenylephrine hcl acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine acesulfame potassium alcohol anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 glycerin maltitol propylene glycol water sodium benzoate sodium citrate nighttime cold and flu acetaminophen, diphenhydramine hci, phenylephrine hci acetaminophen acetaminophen diphenhydramine hydrochloride diphenhydramine phenylephrine hydrochloride phenylephrine acesulfame potassium alcohol anhydrous citric acid edetate disodium fd&c blue no. 1 fd&c red no. 40 glycerin maltitol propylene glycol water sodium benzoate sodium citrate

Indications and Usage:

Uses daytime temporarily relieves these symptoms due to a cold minor aches and pains headache nasal and sinus congestion sore throat cough due to minor throat and bronchial irritation temporarily reduces fever nighttime temporarily relieves these symptoms due to a cold minor aches and pains headache sore throat runny nose sneezing itchy, watery eyes due to hay fever nasal and sinus congestion itchy of the nose or throat cough due to minor throat and bronchial irritation temporarily reduces fever

Warnings:

r 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. nighttime to make a child sleepy with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on the skin if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinsonâs 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. ask a doctor before use if you have daytime liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema nighttime liver disease glaucoma high blood pressure heart disease diabetes thyroid disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema ask a doctor or pharmacist before use if you are daytime taking the blood thinning drug warfarin nighttime the blood thinning drug warfarin sedative or tranquilizers when using this product, daytime do not exceed recommended dosage. nighttime do not exceed recommended dosage alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery marked drowsiness may occur excitability may occur, especially in children stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur 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. nighttime nervousness, dizziness, or sleeplessness occur pain, cough, or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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 and nighttime overdose warning: taking more than the recommended dose can 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 and nighttime liver warning: these products contain 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 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, ot 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. nighttime to make a child sleepy with any other drug containing acetaminophen (prescription or nonprescription). if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on the skin if you are now taking a prescription monoamine oxidase inhibitor (maoi) (certain drugs for depression, psychiatric, or emotional conditions, or parkinsonâs 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. ask a doctor before use if you have daytime liver disease heart disease thyroid disease diabetes high blood pressure trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema nighttime liver disease glaucoma high blood pressure heart disease diabetes thyroid disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, or emphysema ask a doctor or pharmacist before use if you are daytime taking the blood thinning drug warfarin nighttime the blood thinning drug warfarin sedative or tranquilizers when using this product, daytime do not exceed recommended dosage. nighttime do not exceed recommended dosage alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery marked drowsiness may occur excitability may occur, especially in children stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur 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. nighttime nervousness, dizziness, or sleeplessness occur pain, cough, or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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 and nighttime overdose warning: taking more than the recommended dose can 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 exceed recommended dosage. nighttime do not exceed recommended dosage alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery marked drowsiness may occur excitability may occur, especially in children

Dosage and Administration:

Directions daytime and nighttime do not take more than directed (see overdose warning) do not take more than 6 doses (180 ml) in any 24-hour peroid 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: children under 12 years: do not use

Stop Use:

Stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur 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. nighttime nervousness, dizziness, or sleeplessness occur pain, cough, or nasal congestion gets worse or lasts more than 7 days new symptoms occur fever gets worse or lasts more than 3 days redness or swelling is present 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 daytime & nighttime compare to the active ingredients in therafluÂ® expressmaxÂ® daytime & nighttime severe cold & cough* daytime severe cold & cough acetaminophen pain reliever; fever reducer dextromethorphan hbr cough suppressant phenylephrine hci nasal decongestant relief of: nasal congestion; cough; fever; body ache; sore throat; headache berry flavor alcohol content 10% for ages 12 & over nighttime severe cold & cough acetaminophen pain reliever; fever reducer diphenhydramine hci anthihistamine; cough suppressant phenylephrine hci nasal decongestant relief of: nasal congestion; cough; fever; body ache; sore throat; headache dosing cup included berry flavor alcohol content 10% for ages 12 & over fl oz (ml) *this product is not manufactured or distributed by gsk comsumer healthcare, distributor of therafluÂ® expressmaxÂ® daytime & nighttime severe cold & cough. tamper evident: do not use if printed safety seal around or under cap is broken or missing. distributed by: cvs pharmacy, inc. one cvs drive, woonsocket, ri 02895 cvs.comÂ® 1-800-shop cvs

Product label cvs health daytime nighttime relief severe cold & cough acetaminophen 650 mg, dextromethorphan hbr 20 mg phenylephrine hcl 10 mg, acetaminophen 650 mg, diphenhydramine hcl 25 mg, phenylephrine hcl 10 mg

Product label daytime cvs health daytime relief severe cold & cough acetaminophen 650 mg, dextromethorphan hbr 20 mg, phenylephrine hcl 10 mg

Package label nighttime cvs health nighttime relief severe cold & cough acetaminophen 650 mg, diphenhydramine hcl 25 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.