NDC 50580-374 Extra Strength Tylenol Cold Plus Flu Multi-action Day/night

Acetaminophen, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide, And Chlorpheniramine Maleate

NDC Product Code 50580-374

NDC CODE: 50580-374

Proprietary Name: Extra Strength Tylenol Cold Plus Flu Multi-action Day/night What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Acetaminophen, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide, And Chlorpheniramine Maleate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325)
BLUE (C48333)
Shape: OVAL (C48345)
Size(s):
18 MM
Imprint(s):
TY;COLD;1408
TY;COLD;1407
Score: 1

NDC Code Structure

  • 50580 - Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division
    • 50580-374 - Extra Strength Tylenol Cold Plus Flu Multi-action

NDC 50580-374-01

Package Description: 1 KIT in 1 PACKAGE * 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

NDC Product Information

Extra Strength Tylenol Cold Plus Flu Multi-action Day/night with NDC 50580-374 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The generic name of Extra Strength Tylenol Cold Plus Flu Multi-action Day/night is acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate. The product's dosage form is kit and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1089968, 1250743 and 2558505.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POWDERED CELLULOSE (UNII: SMD1X3XO9M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
  • HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • POLYDEXTROSE (UNII: VH2XOU12IE)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • POWDERED CELLULOSE (UNII: SMD1X3XO9M)
  • SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIACETIN (UNII: XHX3C3X673)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division
Labeler Code: 50580
FDA Application Number: part341 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 06-21-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

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

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

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

TYLENOL® COLD + FLU MULTI-ACTION DAYDrug Facts

  • Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.

TYLENOL® COLD + FLU MULTI-ACTION NIGHTDrug Facts

  • Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.

Otc - Purpose

Active ingredients (in each caplet)PurposeAcetaminophen 500 mgPain reliever/fever reducerDextromethorphan HBr 15 mgCough suppressantPseudoephedrine HCl 30 mgNasal decongestant

Active ingredients (in each caplet)PurposeAcetaminophen 500 mgPain reliever/fever reducerChlorpheniramine maleate 2 mgAntihistamineDextromethorphan HBr 15 mgCough suppressantPseudoephedrine HCl 30 mgNasal decongestant

Uses

  • Temporarily relieves these common cold/flu symptoms:minor aches and painsheadachesore throatnasal congestioncoughsinus congestion and pressurehelps clear nasal passagespromotes nasal and sinus drainagetemporarily reduces fever

  • Temporarily relieves these common cold/flu symptoms:minor aches and painsheadachesore throatcoughnasal congestionsinus congestion and pressuresneezing and runny nosehelps clear nasal passagestemporarily reduces fever

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur if you takemore than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product

  • This product contains acetaminophen. Severe liver damage may occur if you takemore than 4,000 mg of acetaminophen in 24 hourswith other drugs containing acetaminophen3 or more alcoholic drinks every day while using this product

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.

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

  • 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 diseaseheart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate glandpersistent or chronic cough such as occurs with smoking, asthma or emphysemacough that occurs with too much phlegm (mucus)

  • Liver diseaseheart diseasehigh blood pressurethyroid diseasediabetestrouble urinating due to an enlarged prostate glandpersistent or chronic cough such as occurs with smoking, asthma or emphysemacough that occurs with too much phlegm (mucus)a breathing problem such as emphysema or chronic bronchitisglaucoma

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Otc - When Using

When using this product do not exceed recommended dose

Stop Use And Ask A Doctor If

  • Nervousness, dizziness, or sleeplessness occurpain, nasal congestion or cough gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough comes back or occurs with rash or headache that lastsThese could be signs of a serious condition.

  • Nervousness, dizziness, or sleeplessness occurpain, nasal congestion or cough gets worse or lasts more than 7 daysfever gets worse or lasts more than 3 daysredness or swelling is presentnew symptoms occurcough comes back or occurs with rash or headache that lastsThese could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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.

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.

Directions

  • Do not take more than directed (see overdose warning)adults and children 12 years and overtake 2 caplets every 6 hours while symptoms lastdo not take more than 6 caplets in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctorchildren under 12 yearsask a doctor

  • Do not take more than directed (see overdose warning)adults and children 12 years and overtake 2 caplets every 6 hours while symptoms lastdo not take more than 6 caplets in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctorchildren under 12 yearsask a doctor

Other Information

  • Store between 20 - 25°C (68 - 77°F).do not use if blister unit is torn or broken

  • Store between 20 - 25°C (68 - 77°F).do not use if blister unit is torn or broken

Inactive Ingredients

Carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, powdered cellulose, pregelatinized starch, propylene glycol, sodium starch glycolate, titanium dioxide

Carnauba wax, FD&C blue No.1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, powdered cellulose, pregelatinized starch, sodium starch glycolate, titanium dioxide, triacetin

Ask A Doctor Or Pharmacist Before Use If You Are

  • Taking the blood thinning drug warfarintaking sedatives or tranquilizers

When Using This Product

  • Do not exceed recommended doseexcitability may occur, especially in childrenmarked drowsiness may occuralcohol, sedatives and tranquilizers may increase drowsinessavoid alcoholic drinksbe careful when driving a motor vehicle or operating machinery

* Please review the disclaimer below.