NDC 50580-177 Tylenol For Children Plus Adults

Acetaminophen

NDC Product Code 50580-177

NDC CODE: 50580-177

Proprietary Name: Tylenol For Children Plus Adults 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 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This drug is used to treat mild to moderate pain (from headaches, menstrual periods, toothaches, backaches, osteoarthritis, or cold/flu aches and pains) and to reduce fever.

Product Characteristics

Color(s):
WHITE (C48325)
Flavor(s):
CHERRY (C73375)

NDC Code Structure

  • 50580 - Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division

NDC 50580-177-08

Package Description: 1 BOTTLE in 1 CARTON > 240 mL in 1 BOTTLE

NDC Product Information

Tylenol For Children Plus Adults with NDC 50580-177 is a a human over the counter drug product labeled by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. The generic name of Tylenol For Children Plus Adults is acetaminophen. The product's dosage form is suspension and is administered via oral form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 307668 and 828555.

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

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.

Tylenol For Children Plus Adults Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


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.

  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL SOLUTION (UNII: 8KW3E207O2)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • SUCROSE (UNII: C151H8M554)
  • XANTHAN GUM (UNII: TTV12P4NEE)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

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: part343 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 07-01-2021 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.

Tylenol For Children Plus Adults Product Label Images

Tylenol For Children Plus Adults 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

Drug 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.

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.

Active Ingredient (In Each 5 Ml)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

  • Temporarily:reduces feverrelieves minor aches and pains due to:the common coldfluheadachesore throattoothachemuscular achesbackacheminor pain of arthritispremenstrual and menstrual cramps

Liver Warning

  • This product contains acetaminophen. Severe liver damage may occur ifadult takes more than 4,000 mg of acetaminophen in 24 hourschild takes more than 5 doses in 24 hours, which is the maximum daily amounttaken with other drugs containing acetaminophenadult has 3 or more alcoholic drinks every day while using this product

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 allergic to acetaminophen or any of the inactive ingredients in this product

Otc - Ask Doctor

Ask a doctor before use if the user has liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin

Otc - When Using

When using this product do not exceed recommended dose (see overdose warning)

Stop Use And Ask A Doctor If

  • Pain gets worse or lasts more than 10 days in adultspain gets worse or lasts more than 5 days in children under 12 yearsfever gets worse or lasts more than 3 daysnew symptoms occurredness or swelling is presentThese could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

Directions

  • Do not give more than directed (see overdose warning)shake well before usingmL = milliliterChildren 2 years to under 12 years:find right dose on chart below. If possible, use weight to dose; otherwise, use age.remove the child protective cap and squeeze the dose into the dosing cuprepeat dose every 4 hours while symptoms lastdo not take more than 5 times in 24 hours unless directed by a doctordo not take for more than 5 days unless directed by a doctorWeight (lb)Age (years)Dose (mL)or as directed by a doctorunder 24under 2 yearsask a doctor24-35 lbs2-3 years5 mL36-47 lbs4-5 years7.5 mL48-59 lbs6-8 years10 mL60-71 lbs9-10 years12.5 mL72-95 lbs11 years15 mLAdults and children 12 years and over:take 20 mL (2 × 10 mL) every 4 hours while symptoms last. For adult dosing, the dosing cup needs to be filled to 10 mL line twice.do not take more than 5 doses (100 mL) in 24 hours unless directed by a doctordo not take for more than 10 days unless directed by a doctorAttention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other Information

  • Each 5 mL contains: potassium 5 mgstore between 20-25°C (68-77°F)do not use if carton tape or bottle wrap imprinted with "TYLENOL" is broken or missing

Inactive Ingredients

Anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum

* Please review the disclaimer below.