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TYLENOL SINUS PLUS HEADACHE DAY Acetaminophen and Phenylephrine hydrochloride 325 mg; 5 mg Tablet, Film Coated

by Kenvue Brands LLC · 2 BLISTER PACK in 1 CARTON (50580-598-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK
NDC 50580-0598-01
🏷️ FDA NDC (as labeled) 50580-598-01 billing pads the product segment with a zero
This package
Contains12 tablet, film coated in 1 blister pack Pack sizes2 compare ↓
Also comes in: 12 tablets 50580-0598-02
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 50580-598-01
Product NDC 50580-598
11-digit billing NDC 50580059801
NCPDP billing unit EA — each (per item)
RxCUI 1046378
UNII 362O9ITL9D, 04JA59TNSJ
Application # M012
SPL Set ID e608d214-cc46-4a24-ac85-1040e36e7403
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2015-07-15
Route ORAL
Dosage form TABLET, FILM COATED
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
GCN Seq No 059707
GCN 25468
HICL code 000436
Ingredient (HICL) Phenylephrine Hcl/Acetaminophn
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B4
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.1)
HIC3 code B4T
Therapeutic class — specific (HIC3) Decongest-Analgesic,Non-Salicylate Comb.
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name TYLENOL SINUS HEADACHE CAPLET
FDB brand name Tylenol Sinus Headache
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 50580-598-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 50580-0598-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Anilides class.

Drug family (ATC) Anilides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerKenvue Brands LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code50580
First marketedJul 2015
Product typeHuman Otc Drug
Portfolio567 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name TYLENOL SINUS HEADACHE CAPLET Ingredient Phenylephrine Hcl/Acetaminophn
🧪 What is this product?

Tylenol Sinus Plus Headache Day is an over-the-counter oral tablet containing acetaminophen and phenylephrine hydrochloride. Acetaminophen is typically used to reduce pain and fever, while phenylephrine hydrochloride functions as a nasal decongestant. This combination product is formulated to address multiple symptoms commonly associated with sinus congestion and headache.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII J9EQA3S2JM
    FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII SMD1X3XO9M
    Powdered cellulose is a fine, plant-based powder made from purified wood fibers. In medicines, it acts as a filler to add bulk and volume, and helps tablets or capsules hold together during manufacturing and storage.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

18 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesanhydrous citric acid, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polysorbate 80, potassium sorbate, powdered cellulose, pregelatinized starch, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose, titanium dioxide

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 12 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sinus Congestion and Pain Maximum Strength 325 mg/1; 5 mg 00536-1289-35 Rugby 24 tablets $0.085 — Availability likely —
Sinus Pressure Pain Maximum Strength, Non-Drowsy 325 mg/1; 5 mg 46122-0443-62 Amerisource 24 tablets $0.085 — Availability likely —
Sinus Pressure and Pain Maximum Strength 325 mg/1; 5 mg 70000-0161-01 Cardinal 24 tablets $0.085 — Availability likely —
Sinus and Headache 325 mg/1; 5 mg 70000-0568-01 Cardinal 12 tablets $0.085 — Availability likely —
Sinus plus Headache 325 mg/1; 5 mg 83324-0094-24 CHAIN 12 tablets $0.085 — Availability likely —
Panadol Cold and Flu NonDrowsy 325 mg/1; 5 mg 00135-0607-02 Haleon 8 tablets — — FDA listed —
Panadol Cold and Flu NonDrowsy 325 mg/1; 5 mg 00135-7031-01 Haleon 2 tablets — — FDA listed —
Sinus and Headache 325 mg/1; 5 mg 00363-4066-08 Walgreen 12 tablets — — FDA listed —
Sinus And Headache 325 mg/1; 5 mg 11822-4669-08 Rite 12 tablets — — FDA listed —
Sinus Pressure and Pain PE Maximum Strength 325 mg/1; 5 mg 11822-5022-08 Rite 24 tablets — — FDA listed —
Pain Relief Non Drowsy Daytime 325 mg/1; 5 mg 21130-0466-08 Better 12 tablets — — Discontinued —
Pain Relief Sinus Congestion 325 mg/1; 5 mg 21130-0474-08 Better 12 tablets — — FDA listed —
Sinus Relief MAXIMUM STRENGTH 325 mg/1; 5 mg 21130-0502-21 Better 24 tablets — — FDA listed —
Sinus Plus Headache 325 mg/1; 5 mg 30142-0466-08 Kroger 12 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 36800-0320-06 TOPCO 12 tablets — — FDA listed —
Sinus plus Headache 325 mg/1; 5 mg 36800-0322-05 TOPCARE 12 tablets — — FDA listed —
Sinus Congestion and Pain Daytime Non-Drowsy 325 mg/1; 5 mg 37808-0466-08 H 12 tablets — — FDA listed —
Sinus Congestion and Pain Daytime 325 mg/1; 5 mg 41163-0664-08 United 12 tablets — — FDA listed —
Sinus and Headache 325 mg/1; 5 mg 42507-0223-05 HYVEE 12 tablets — — FDA listed —
Sinus Pressure and Pain PE 325 mg/1; 5 mg 42507-0320-06 HYVEE 12 tablets — — FDA listed —
Sudafed PE Sinus Pressure Plus Pain 325 mg/1; 5 mg 50580-0435-01 Kenvue 12 tablets — — FDA listed —
SUDAFED PE Pressure Plus Pain 325 mg/1; 5 mg 50580-0547-25 Kenvue 12 tablets — — FDA listed —
Tylenol Sinus Plus Headache Day 325 mg/1; 5 mgthis 50580-0598-01 Kenvue 12 tablets — — Discontinued —
Sinus and Headache 325 mg/1; 5 mg 50804-0123-05 GOODSENSE 12 tablets — — FDA listed —
sinus pressure and pain pe 325 mg/1; 5 mg 50804-0220-06 GOODSENSE 12 tablets — — FDA listed —
Sinus and Headache Daytime 325 mg/1; 5 mg 50844-0467-02 L.N.K. 12 tablets — — FDA listed —
Coltalin-Nd 325 mg/1; 5 mg 51467-0008-01 FORTUNE 24 tablets — — FDA listed —
Coltalin-Nd 325 mg/1; 5 mg 51467-0013-01 FORTUNE 24 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 53943-0220-06 DISCOUNT 12 tablets — — FDA listed —
Sinus And Headache 325 mg/1; 5 mg 53943-0323-05 DISCOUNT 12 tablets — — FDA listed —
Sinus Headache and Pain Day, Non-drowsy 325 mg/1; 5 mg 55301-0446-08 ARMY 12 tablets — — FDA listed —
Suphedrine PE Sinus Pressure Plus Pain 325 mg/1; 5 mg 55301-0902-08 ARMY 24 tablets — — FDA listed —
Sinus and Headache 325 mg/1; 5 mg 55319-0496-08 Family 12 tablets — — FDA listed —
Sinus Pressure and Pain 325 mg/1; 5 mg 55319-0702-08 Family 24 tablets — — FDA listed —
Sinus and Headache Daytime 325 mg/1; 5 mg 55910-0466-08 DOLGENCORP, 12 tablets — — FDA listed —
Sinus Pressure and Pain Maximum Strength 325 mg/1; 5 mg 55910-0925-08 DOLGENCORP, 24 tablets — — FDA listed —
Sinus and Headache 325 mg/1; 5 mg 57344-0923-05 AAA 12 tablets — — FDA listed —
Sinus Pain And Congestion Daytime 325 mg/1; 5 mg 59779-0466-08 CVS 12 tablets — — FDA listed —
Sinus PE Pressure plus Pain MAXIMUM STRENGTH 325 mg/1; 5 mg 59779-0802-08 CVS 24 tablets — — FDA listed —
Sinus plus Headache 325 mg/1; 5 mg 63868-0582-24 CHAIN 12 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 63941-0220-06 VALU 12 tablets — — FDA listed —
Nasal Decongestant PE and Pain Relief Maximum Strength 325 mg/1; 5 mg 67091-0209-24 WinCo 24 tablets — — FDA listed —
Sinus Congestion and Pain Relief Non-Drowsy 325 mg/1; 5 mg 67091-0213-24 WinCo 12 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 68998-0220-06 MARC 12 tablets — — FDA listed —
Sinus plus Headache 325 mg/1; 5 mg 68998-0323-05 MARC 12 tablets — — FDA listed —
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy 325 mg/1; 5 mg 69168-0270-95 Allegiant 18 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 72036-0320-06 Harris 12 tablets — — FDA listed —
Sinus plus Headache 325 mg/1; 5 mg 72036-0323-05 Harris 12 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 72476-0120-06 RETAIL 12 tablets — — FDA listed —
Sinus And Headache 325 mg/1; 5 mg 72476-0123-05 RETAIL 12 tablets — — FDA listed —
Sudafed PE Sinus Pressure Plus Pain 325 mg/1; 5 mg 85766-0183-24 Sportpharm 12 tablets — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2015
On the market since
Jul 2015
📍
2026
Currently FDA-listed
11 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Acetaminophen and Phenylephrine hydrochloride — the ingredient across all brands.

Top reported reactions

Foetal Exposure During Pregnancy4
Autism Spectrum Disorder2
Blood Pressure Increased2
Headache2
Blood Urine Present1
Cardiac Arrest1
Cerebrovascular Accident1

Reporter sex

21 reports
Male · 44%
Female · 56%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
50580-0598-01 You're viewing this 2 BLISTER PACK in 1 CARTON (50580-598-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2015-07-15 Discontinued by firm
50580-0598-02 2 BLISTER PACK in 1 CARTON (50580-598-02) / 12 TABLET, FILM COATED in 1 BLISTER PACK 2019-05-08 Active

Pack size FAQ

What quantity is in NDC 50580-0598-01?
NDC 50580-0598-01 is listed by the FDA — 2 blister pack in 1 carton / 12 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of TYLENOL SINUS PLUS HEADACHE DAY Acetaminophen and Phenylephrine hydrochloride 325 mg; 5 mg Tablet, Film Coated?
Bill NDC 50580-0598-01 — the 11-digit billing format is 50580059801. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 50580-598-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 50580-0598-01, written without dashes as 50580059801. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 50580-0598-01, the first segment (50580) is the labeler code FDA assigned to Kenvue Brands LLC; the middle segment (0598) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 12 tablets (50580-0598-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Kenvue Brands LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 44 words ▾

Uses temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold: headache sinus congestion and pressure nasal congestion minor aches and pains helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever

⏱️ Dosage and Administration 49 words ▾

Directions do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours swallow whole; do not crush, chew or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

⚠️ Warnings ~2 min read ▾

Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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. 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 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 or nasal congestion 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 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.

📦 Storage and Handling 16 words ▾

Other information store between 20-25°C (68-77°F) do not use if blister unit is torn or broken

🧪 Active Ingredient 18 words ▾

Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Phenylephrine HCl 5 mg Nasal decongestant

🧪 Inactive Ingredients 53 words ▾

Inactive ingredients anhydrous citric acid, carnauba wax, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C red no. 40 aluminum lake, flavors, hypromellose, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polysorbate 80, potassium sorbate, powdered cellulose, pregelatinized starch, sodium benzoate, sodium citrate, sodium starch glycolate, sucralose, titanium dioxide

🎯 Purpose 18 words ▾

Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Phenylephrine HCl 5 mg Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 50580-0590-04 · Kenvue 50580-0599-01 · Kenvue →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.