Daytime And Nighttime Cold/flu Relief

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Doxylamine Succinate


Pharmacy Value Alliance, Llc
Human Otc Drug
NDC 68016-882
Daytime And Nighttime Cold/flu Relief also known as Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Doxylamine Succinate is a human otc drug labeled by 'Pharmacy Value Alliance, Llc'. National Drug Code (NDC) number for Daytime And Nighttime Cold/flu Relief is 68016-882. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Daytime And Nighttime Cold/flu Relief drug includes . The currest status of Daytime And Nighttime Cold/flu Relief drug is Active.

Drug Information:

Drug NDC: 68016-882
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 And Nighttime Cold/flu 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 Hydrobromide, Phenylephrine Hydrochloride, Doxylamine Succinate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Pharmacy Value Alliance, 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:
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: 28 Feb, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 31 Dec, 2023
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: 22 Dec, 2025
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:Pharmacy Value Alliance, LLC
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1086997
1094549
1311150
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
68016-882-481 KIT in 1 CARTON (68016-882-48) * 4 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK28 Feb, 202031 Dec, 2023No
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:

Purpose (daytime only) acetaminophen …………...... pain reliever/fever reducer dextromethorphan hbr …... cough suppressant phenylephrine hcl ………..... nasal decongestant

Product Elements:

Daytime and nighttime cold/flu relief acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, doxylamine succinate daytime cold/flu relief acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin polyethylene glycol, unspecified povidone propylene glycol water sorbitol sorbitan titanium dioxide to red 604 nighttime cold/flu relief acetaminophen, dextromethorphan hydrobromide, doxylamine succinate acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan doxylamine succinate doxylamine d&c yellow no. 10 fd&c blue no. 1 gelatin glycerin polyethylene glycol, unspecified povidone propylene glycol water sorbitol sorbitan titanium dioxide 603

Indications and Usage:

Uses (daytime only) temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever

Uses (nighttime only) temporarily relieves common cold/flu symptoms: • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever • runny nose & sneezing

Warnings:

Warnings (daytime only) liver warning: this product contains acetaminophen. severe liver damage may occur if you take: • more than 4 doses in 24 hrs, 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, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use • 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 depressio
n, 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. ask a doctor before use if you have • 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 as occurs with smoking, asthma, or emphysema ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product do not use more than directed stop use and ask a doctor if • you get nervous, dizzy or sleepless • symptoms get worse or last more than 5 days (children) or 7 days (adults) • 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. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as children, even if you do not notice any signs or symptoms.

Warnings (nighttime only) liver warning : this product contains acetaminophen. severe liver damage may occur if you take: • more than 4 doses in 24 hrs, 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, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use • 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 depress
ion, 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. • to make a child sleep ask a doctor before use if you have • liver disease •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 ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin when using thls product • do not use 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 & tranquilizers may increase drowsiness stop use and ask a doctor if • pain or cough gets worse or lasls more than 7days • 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. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as children, even if you do not notice any signs or symptoms.

Do Not Use:

Warnings (daytime only) liver warning: this product contains acetaminophen. severe liver damage may occur if you take: • more than 4 doses in 24 hrs, 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, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use • 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. ask a doctor before use if you have • 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 as occurs with smoking, asthma, or emphysema ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. when using this product do not use more than directed stop use and ask a doctor if • you get nervous, dizzy or sleepless • symptoms get worse or last more than 5 days (children) or 7 days (adults) • 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. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as children, even if you do not notice any signs or symptoms.

Warnings (nighttime only) liver warning : this product contains acetaminophen. severe liver damage may occur if you take: • more than 4 doses in 24 hrs, 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, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. do not use • 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. • to make a child sleep ask a doctor before use if you have • liver disease •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 ask a doctor or pharmacist before use if you are • taking sedatives or tranquilizers • taking the blood thinning drug warfarin when using thls product • do not use 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 & tranquilizers may increase drowsiness stop use and ask a doctor if • pain or cough gets worse or lasls more than 7days • 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. in case of overdose, get medical help or contact a poison control center right away. quick medical attention is critical for adults as well as children, even if you do not notice any signs or symptoms.

When Using:

When using this product do not use more than directed

When using thls product • do not use 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 & tranquilizers may increase drowsiness

Dosage and Administration:

Directions (daytime only) take only as directed (see warnings) do not exceed 4 doses in 24 hrs adults and 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 • when using other daytime or nighttime products, carefully read each label to ensure correct dosing

Directions (nighttime only) take only as directed (see warnings) do not exceed 4 doses in 24 hrs adults and children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use •when using other daytime or nighttime products, carefully read each label to ensure correct dosing

Stop Use:

Stop use and ask a doctor if • you get nervous, dizzy or sleepless • symptoms get worse or last more than 5 days (children) or 7 days (adults) • 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.

Stop use and ask a doctor if • pain or cough gets worse or lasls more than 7days • 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 package label premier **compare to the active ingredients in value ® vicks ® dayquil ® and vicks ® nyquil ® liquicaps ​ ​ ​® ​ non-drowsy multi-symptom daytime nighttime cold/flu relief acetaminophen acetaminophen / dextromethorphan hbr/ dextromethorphan hbr/phenylephrine hcl doxylamine succinate • aches, fever & sore throat • headache, fever, sore throat, minor aches and pains • nasal congestion • sneezing, runny nose • cough • cough alcohol - free antihistamine - free 32 softgels 16 softgels 48 total softgels independently tested pv satisfaction guaranteed **this product is not manufactured or distributed by procter & gamble, owner of the registered trademark vicks ® dayquil ® liquicaps ® . **this product is not manufactured or distributed by procter & gamble, owner of the registered trademark vicks ® nyquil ® liquicaps ® . dlstribuled by: pharmacy value alliance, llc 407 east lancaster avenue, wayne, pa 19087 if for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund. tamper evident: do not use if carton is opened or if blister unit is torn, broken or shows any signs of tampering. keep outer cartoin for complete warnings and product information. bx-095 1 987495 1/20 res day & night 882 box

Further Questions:

Questions? (daytime & nighttime) call weekdays from 9:30 am to 4:30 pm est at 1-877-798-5944


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.