Extra Strength Tylenol Cold Plus Flu Multi-action Day/night

Acetaminophen, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide, And Chlorpheniramine Maleate

Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division
Human Otc Drug
NDC 50580-374

Extra Strength Tylenol Cold Plus Flu Multi-action Day/night also known as Acetaminophen, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide, And Chlorpheniramine Maleate is a human otc drug labeled by 'Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division'. National Drug Code (NDC) number for Extra Strength Tylenol Cold Plus Flu Multi-action Day/night is 50580-374. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Extra Strength Tylenol Cold Plus Flu Multi-action Day/night drug includes . The currest status of Extra Strength Tylenol Cold Plus Flu Multi-action Day/night drug is Active.

Drug Information:

Drug NDC:	50580-374
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:	Extra Strength Tylenol Cold Plus Flu Multi-action Day/night
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base:	Extra Strength Tylenol Cold Plus Flu Multi-action
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix:	Day/Night
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
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, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide, And Chlorpheniramine Maleate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division
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:	21 Jun, 2021
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	15 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:	Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1089968 1250743 2558505
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:	0300450149244
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
50580-374-01	1 KIT in 1 PACKAGE (50580-374-01) * 2 BLISTER PACK in 1 CARTON / 8 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK	21 Jun, 2021	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

Extra Strength Tylenol Cold Plus Flu Multi-action Day/night

Acetaminophen & more..

Kit
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC: 50580-374

Purpose:

Active ingredients (in each caplet) purpose acetaminophen 500 mg pain reliever/fever reducer dextromethorphan hbr 15 mg cough suppressant pseudoephedrine hcl 30 mg nasal decongestant

Active ingredients (in each caplet) purpose acetaminophen 500 mg pain reliever/fever reducer chlorpheniramine maleate 2 mg antihistamine dextromethorphan hbr 15 mg cough suppressant pseudoephedrine hcl 30 mg nasal decongestant

Product Elements:

Extra strength tylenol cold plus flu multi-action day/night acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate extra strength tylenol cold plus flu multi-action day acetaminophen, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide carnauba wax hypromellose, unspecified magnesium stearate microcrystalline cellulose powdered cellulose propylene glycol sodium starch glycolate type a titanium dioxide acetaminophen acetaminophen pseudoephedrine hydrochloride pseudoephedrine dextromethorphan hydrobromide dextromethorphan ty;cold;1408 extra strength tylenol cold plus flu multi-action night acetaminophen, chlorpheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide carnauba wax fd&c blue no. 1 aluminum lake hypromellose, unspecified magnesium stearate microcrystalline cellulose polydextrose propylene glycol powdered cellulose sodium starch glycolate type a titanium dioxide triacetin acetaminophen acetaminophen chlorpheniramine maleate chlorpheniramine pseudoephedrine hydrochloride pseudoephedrine dextromethorphan hydrobromide dextromethorphan ty;cold;1407

Indications and Usage:

Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure helps clear nasal passages promotes nasal and sinus drainage temporarily reduces fever

Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat cough nasal congestion sinus congestion and pressure sneezing and runny nose helps clear nasal passages temporarily reduces fever

Warnings:

g. 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 ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes 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) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin when using this product do not exceed recommended dose stop use and ask a doctor if 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. overdose warning in case of overdose, get medical help or contact a poison control center right away. (1-800-222-1222) quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

g. 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 ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes 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) a breathing problem such as emphysema or chronic bronchitis glaucoma ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product do not exceed recommended dose excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if 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. overdose warning in case of overdose, get medical help or contact a poison control center right away. (1-800-222-1222) 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 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 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 ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes 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) ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin when using this product do not exceed recommended dose stop use and ask a doctor if 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. overdose warning in case of overdose, get medical help or contact a poison control center right away. (1-800-222-1222) quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Warnings 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 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 ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes 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) a breathing problem such as emphysema or chronic bronchitis glaucoma ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers when using this product do not exceed recommended dose excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery stop use and ask a doctor if 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. overdose warning in case of overdose, get medical help or contact a poison control center right away. (1-800-222-1222) 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 do not exceed recommended dose

When using this product do not exceed recommended dose excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery

Dosage and Administration:

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

Stop Use:

Stop use and ask a doctor if 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 ndc 50580-374-01 extra strength tylenol Â® for adults cold + flu multi-action acetaminophen dextromethorphan hbr, pseudoephedrine hcl pain reliever-fever reducer, cough suppressant, nasal decongestant day head + body aches fever + sore throat cough nasal congestion actual size 16 caplets; acetaminophen chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl pain reliever-fever reducer, antihistamine, cough suppressant, nasal decongestant night head + body aches fever + sore throat cough â¢ nasal congestion runny nose actual size 8 caplets; total 24 caplets tylenol-01

Further Questions:

Questions or comments? call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

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.