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Sinus and Headache ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE 325 mg; 5 mg Tablet, Coated — NDC 57344-0923-05 package photo

Sinus and Headache ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE 325 mg; 5 mg Tablet, Coated

by AAA Pharmaceutical, Inc. · 2 BLISTER PACK in 1 CARTON (57344-923-05) / 12 TABLET, COATED in 1 BLISTER PACK
NDC 57344-0923-05
🏷️ FDA NDC (as labeled) 57344-923-05 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ 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

🆔 Identity & classification

FDA NDC (as labeled) 57344-923-05
Product NDC 57344-923
11-digit billing NDC 57344092305
RxCUI 1046378
UNII 362O9ITL9D, 04JA59TNSJ
Application # M012
SPL Set ID 73d4fc82-8508-44f8-83ca-9f32c5cd847b
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-08-01
Route ORAL
Dosage form TABLET, COATED
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 57344-923-05 — 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 → 57344-0923-05. 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

LabelerAAA Pharmaceutical, Inc.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code57344
First marketedAug 2020
Product typeHuman Otc Drug
Portfolio26 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

📖 About the active ingredient: Acetaminophen; Phenylephrine Hydrochloride MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is an oral tablet product that combines two active ingredients typically used together for sinus and headache relief. Acetaminophen is commonly used as a pain reliever and fever reducer. Phenylephrine hydrochloride is a decongestant that functions to help relieve sinus congestion and nasal stuffiness. This is an over-the-counter monograph product, meaning it is marketed under FDA's established rules for this category of medication.

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.

💊 What it looks like

Color green
ShapeOval
ImprintAAA;1123
Size17 mm
ScoringNot scored
FlavorMint
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • 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 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 M28OL1HH48
    Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
  • UNII 2S7830E561
    Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
  • UNII 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • 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 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 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 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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 statesacesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, 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.
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 mg 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 mgthis 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

🏛️
2020
On the market since
Aug 2020
📍
2026
Currently FDA-listed
6 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

Age at onset

Adolescent1
Adult2
Elderly1

Reporter sex

21 reports
Male · 44%
Female · 56%
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 3 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
57344-0923-05 You're viewing this 2 BLISTER PACK in 1 CARTON (57344-923-05) / 12 TABLET, COATED in 1 BLISTER PACK 2020-08-01 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
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 ✓ Available
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.
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 57344-923-05, 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: 57344-0923-05, written without dashes as 57344092305. 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 57344-0923-05, the first segment (57344) is the labeler code FDA assigned to AAA Pharmaceutical, Inc.; the middle segment (0923) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by AAA Pharmaceutical, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
AAA Pharmaceutical, Inc. 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 45 words ▾

Uses temporarily relieves these symptoms associated with hay fever or other upper 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 dosage 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 18 words ▾

Other information store between 20-25°C (68-77°F) in a dry place retain carton for complete product information and warnings

🧪 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 44 words ▾

Inactive ingredients acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, 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 ↗
← 57344-0811-03 · AAA 57344-0928-02 · AAA →
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.