Daytime Nighttime Cold Flu Relief

Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl


Bjwc (berkley & Jensen / Bj's)
Human Otc Drug
NDC 68391-472
Daytime Nighttime Cold Flu Relief also known as Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl is a human otc drug labeled by 'Bjwc (berkley & Jensen / Bj's)'. National Drug Code (NDC) number for Daytime Nighttime Cold Flu Relief is 68391-472. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Daytime Nighttime Cold Flu Relief drug includes . The currest status of Daytime Nighttime Cold Flu Relief drug is Active.

Drug Information:

Drug NDC: 68391-472
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 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 Hbr, Doxylamine Succinate, Phenylephrine Hcl
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Bjwc (berkley & Jensen / Bj's)
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 Mar, 2016
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: 15 Jan, 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:BJWC (Berkley & Jensen / BJ's)
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1086997
1094549
1366501
1426334
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:0888670010037
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
68391-472-721 KIT in 1 CARTON (68391-472-72) * 24 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK * 48 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK31 Mar, 201631 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.
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Daytime Nighttime Cold And Flu Relief Multi-symptom


Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate, Phenylephrine Hcl

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NDC: 41250-653

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Purpose:

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

Purpose for nighttime pain reliever/fever reducer cough suppressant antihistamine

Product Elements:

Daytime nighttime cold flu relief acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl 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 sorbitan sorbitol p30;94a;scu1;215;p120 daytime cold flu relief acetaminophen, dextromethorphan hbr, phenylephrine hcl acetaminophen acetaminophen dextromethorphan hydrobromide dextromethorphan phenylephrine hydrochloride phenylephrine butylated hydroxyanisole butylated hydroxytoluene fd&c red no. 40 fd&c yellow no. 6 gelatin glycerin polyethylene glycol, unspecified povidone propylene glycol water sorbitan sorbitol carminic acid sodium metabisulfite d&c yellow no. 10 p19;95a;512;p119

Indications and Usage:

Uses daytime temporarily relieves common cold and flu symptoms cough due to minor throat and bronchial irritation nasal congestion headache minor aches and pains fever sore throat nighttime temporarily relieves common cold and flu symptoms cough due to minor throat and bronchial irritation sore throat headache minor aches and pains fever runny nose and sneezing

Warnings:

Warnings daytime 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 these products 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 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 alergy 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 following by fever, headache, rash, nausea, 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 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. 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 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 daytime liver disease heart disease diabetes thyroid disease high blood pressure cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema nighttime liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are daytime taking the blood thinning drug warfarin nighttime taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product, daytime do not use more than directed nighttime excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur pain, cough, and nasal congestion gets worse or lasts more than 7 days redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days cough comes back or occurs with rash or headache that lasts these could be signs of a serious condition. nighttime pain 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 headache that lasts. these could be a signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. 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 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: 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 these products 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 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 alergy 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 following by fever, headache, rash, nausea, 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 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. 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 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 daytime liver disease heart disease diabetes thyroid disease high blood pressure cough that occurs with too much phlegm (mucus) trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema nighttime liver disease glaucoma cough that occurs with too much phlegm (mucus) a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema trouble urinating due to an enlarged prostate gland ask a doctor or pharmacist before use if you are daytime taking the blood thinning drug warfarin nighttime taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product, daytime do not use more than directed nighttime excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur pain, cough, and nasal congestion gets worse or lasts more than 7 days redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days cough comes back or occurs with rash or headache that lasts these could be signs of a serious condition. nighttime pain 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 headache that lasts. these could be a signs of a serious condition. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. 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 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 use more than directed nighttime excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery

Dosage and Administration:

Directions daytime do not take more than directed (see overdose warning) do not take more than 4 doses in 24 hours swallow whole; do not crush, chew, or dissolve adults and children 12 years and over; take 2 softgels with water every 4 hours. children under 12 years: do not use nighttime do not take more than directed (see overdose warning) do not take more than 4 doses in 24 hours swallow whole; do not crush, chew, or dissolve adults and children 12 years and over: take 2 softgels with water every 6 hours children under 12 years: do not use

Stop Use:

Stop use and ask a doctor if daytime nervousness, dizziness or sleeplessness occur pain, cough, and nasal congestion gets worse or lasts more than 7 days redness or swelling is present new symptoms occur fever gets worse or lasts more than 3 days cough comes back or occurs with rash or headache that lasts these could be signs of a serious condition. nighttime pain 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 headache that lasts. these could be a signs of a serious condition.

Package Label Principal Display Panel:

Principal display panel compare to the active ingredients in vicks® dayquil® and nyquil® liquicaps®† daytime multi-symptom cold & flu relief acetaminophen - pain reliever / fever reducer dextromethorphan hbr - cough suppressant phenylephrine hci - nasal congestant non-drowsy alcohol free antihistamine free softgels** (** liquid-filled capsules) nighttime multi-symptom cold & flu relief acetaminophen - pain reliever / fever reducer dextromethorphan hbr - cough suppressant doxylamine succinate - antihistamine softgels** (**liquid-filled capsules) when using daytime and nighttime products, carefully read the labeling to ensure correct dosing. †this product is not manufactured or distributed by the procter & gamble company. vicks®, dayquil, nyquil®, and liquicaps® are registered trademarks of the procter and gamble company. tamper evident: do not use if carton is opened or if blister unit is torn, broken or show signs of tampering. keep outer carton for complete warnings and product information distributed by: bj's wholesale cxlub 25 research drive westborough, ma 01581

Product label bj's daytime nighttime cold & flu relief acetaminophen 325 mg, dextromethorphan hbr 10 mg, phenylephrine hci 5 mg, acetaminophen 325 mg, dextromethorphan hbr 15 mg, doxylamine succinate 6.25 mg

Further Questions:

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* 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.