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TYLENOL Cold Plus Flu Severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride 325 mg; 10 mg; 200 mg; 5 mg Tablet, Film Coated — NDC 85237-1956-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

TYLENOL Cold Plus Flu Severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride 325 mg; 10 mg; 200 mg; 5 mg Tablet, Film Coated — NDC 85237-1956-3 (Billing 85237-1956-03)

by Select Consumer Group · 20 POUCH in 1 BOX / 2 TABLET, FILM COATED in 1 POUCH

This is a package of TYLENOL Cold Plus Flu Severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride 325 mg; 10 mg; 200 mg; 5 mg Tablet, Film Coated from Select Consumer Group, marketed since Sep 2011 and currently FDA-listed.

NDC 85237-1956-03
🏷️ FDA NDC (as labeled) 85237-1956-3 billing pads the package segment with a zero
This package
Contains2 tablet, film coated in 1 pouch Pack sizes6 compare ↓
Product page 85237-1956-01 Also comes in: 2 tablets 85237-1956-1 2 tablets 85237-1956-2 2 tablets 85237-1956-4 2 tablets 85237-1956-6 2 tablets 85237-1956-7
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85237-1956-3
Product NDC 85237-1956
11-digit billing NDC 85237195603
RxCUI 1110988
UNII 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
UPC 0655708129449
Application # M012
SPL Set ID 55bddbea-5ad9-6a18-e063-6394a90a461d
Established class (EPC) Expectorant
Physiologic effect Decreased Respiratory Secretion Viscosity; Increased Respiratory Secretions
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-09-01
Route ORAL
Dosage form TABLET, FILM COATED
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1110988
Why two NDCs? The FDA registers this code as 85237-1956-3 — a 5-4-1 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 package segment → 85237-1956-03. 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.

Clinical

📖 About the active ingredient 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 over-the-counter combination tablet taken by mouth that contains four active ingredients commonly used together for cold and flu symptom relief. Acetaminophen is typically used to reduce fever and ease pain or aches. Dextromethorphan is a cough suppressant, while guaifenesin functions as an expectorant to help thin mucus and make coughs more productive. Phenylephrine is a nasal decongestant meant to relieve sinus congestion. This product is marketed under FDA's over-the-counter monograph rules for multi-ingredient cold and flu remedies.

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.

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: 2 tablets 2 tablets 2 tablets 2 tablets 2 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
85237-1956-01 85237-1956-1 Main listing 1 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH 2024-09-11 — Active
85237-1956-02 85237-1956-2 2 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH 2024-09-11 — Active
85237-1956-03 You're viewing this 20 POUCH in 1 BOX / 2 TABLET, FILM COATED in 1 POUCH 2024-09-11 — Active
85237-1956-04 85237-1956-4 25 POUCH in 1 BOX / 2 TABLET, FILM COATED in 1 POUCH 2024-09-11 — Active
85237-1956-06 85237-1956-6 50 POUCH in 1 BOX / 2 TABLET, FILM COATED in 1 POUCH 2024-09-11 — Active
85237-1956-07 85237-1956-7 3 POUCH in 1 BLISTER PACK / 2 TABLET, FILM COATED in 1 POUCH 2024-09-11 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 20 pouch in 1 box / 2 tablet, film coated in 1 pouch.
What NDC number is used to bill for this package of TYLENOL Cold Plus Flu Severe Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride 325 mg; 10 mg; 200 mg; 5 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mucus Relief Cold and Flu All in One 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 83324-0105-20 CHAIN 10 tablets $0.132 — Availability likely —
Mucus Relief Cold Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 83324-0104-20 CHAIN 10 tablets $0.132 — Availability likely —
Mucus Relief Sinus Pressure Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 83324-0106-20 CHAIN 10 tablets $0.132 — Availability likely —
Cold plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 83324-0111-24 CHAIN 12 tablets $0.132 — Availability likely —
Cold Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 46122-0418-62 AmeriSource 12 tablets $0.132 — Availability likely —
Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63824-0242-20 Reckitt 10 tablets $0.603 — FDA listed —
Maximum Strength Mucinex Fast-Max Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63824-0575-04 Reckitt 2 tablets $0.603 — FDA listed —
Mucinex Fast-Max Cold, Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63824-0237-20 Reckitt 10 tablets $0.603 — FDA listed —
mucus relief cold flu and sore throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 41250-0197-04 Meijer 10 tablets — — Discontinued —
mucus relief all in one cold and flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 41250-0981-04 Meijer 10 tablets — — Discontinued —
Mucus Relief Cold and Flu All in One 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72036-0298-04 HARRIS 10 tablets — — FDA listed —
Mucus Relief Cold Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63868-0588-20 CHAIN 10 tablets — — FDA listed —
Mucus Relief Cold and Flu All in One 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63868-0589-20 CHAIN 10 tablets — — FDA listed —
Tylenol Cold plus Flu Severe, CVP HEALTH 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 66715-6556-02 Lil 2 tablets — — FDA listed —
Lil Drug Store Tylenol Cold plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 66715-9756-02 Lil 2 tablets — — FDA listed —
Mucus Relief Sinus Pressure Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72036-0199-02 HARRIS 10 tablets — — FDA listed —
Cold and Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72476-0163-05 RETAIL 12 tablets — — FDA listed —
TYLENOL Cold Plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 50580-0402-01 Kenvue 2 tablets — — FDA listed —
Severe Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 42507-0278-03 HYVEE 12 tablets — — FDA listed —
COLD and FLU SEVERE 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 53943-0163-05 DISCOUNT 12 tablets — — FDA listed —
Daytime Severe Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 53943-0178-03 DISCOUNT 12 tablets — — FDA listed —
sinus pressure pain and cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 56062-0399-02 PUBLIX 10 tablets — — FDA listed —
Tylenol Cold plus Flu Severe, TRAVEL BASIX 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 66715-7856-02 Lil 2 tablets — — FDA listed —
DayQuil Severe Plus VapoCOOL Cold And Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 66715-9904-02 Lil' 2 tablets — — FDA listed —
Mucus Relief Sinus Pressure Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 67091-0299-02 WINCO 10 tablets — — FDA listed —
Mucus Relief Cold Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72036-0297-04 HARRIS 10 tablets — — FDA listed —
Sinus Relief Pressure, Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63941-0399-02 VALU 10 tablets — — FDA listed —
Mucus Relief Cold and Flu All in One 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63941-0498-04 VALU 10 tablets — — FDA listed —
Daytime Severe Cold And Flu Maximum Strength 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 37808-0178-03 HEB 12 tablets — — FDA listed —
Mucus Relief Cold, Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 37808-0497-04 HEB 10 tablets — — FDA listed —
Cold Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 37808-0663-05 HEB 12 tablets — — FDA listed —
Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 56062-0198-04 PUBLIX 10 tablets — — FDA listed —
Mucus Relief Cold Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63941-0497-04 VALU 10 tablets — — FDA listed —
TYLENOL Cold Plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 67751-0240-01 Navajo 2 tablets — — FDA listed —
Cold Flu And Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72476-0197-04 RETAIL 10 tablets — — FDA listed —
Mucus Relief Sinus Pressure Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 53943-0199-02 DISCOUNT 10 tablets — — FDA listed —
Cold Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 56062-0197-04 PUBLIX 10 tablets — — FDA listed —
Tylenol Cold plus Flu Severe, Lil Drug Store 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 66715-6456-07 Lil 2 tablets — — FDA listed —
Mucus Relief Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 37808-0598-04 HEB 10 tablets — — FDA listed —
TYLENOL Cold Plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 53209-1003-02 Morning 2 tablets — — FDA listed —
Mucus Relief Sinus Pressure Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63868-0587-20 CHAIN 10 tablets — — FDA listed —
Cold plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63941-0263-05 VALU 12 tablets — — FDA listed —
Cold plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 68998-0263-05 MARC 12 tablets — — FDA listed —
Mucus Relief Cold and Flu All In One 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 36800-0298-04 TOPCARE 10 tablets — — FDA listed —
Cold And Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 36800-0502-05 TOPCARE 12 tablets — — FDA listed —
DayQuil Severe plus Vicks VapoCool Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 37000-0524-02 The 2 tablets — — FDA listed —
Mucus Relief Cold Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 53943-0197-04 DISCOUNT 10 tablets — — FDA listed —
DayQuil Severe plus VapoCOOL Cold and Flu, Travel BASIX 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 66715-6404-02 Lil' 2 tablets — — FDA listed —
Mucus Relief Sinus Pressure Pain and Cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 69842-0796-02 CVS 10 tablets — — Discontinued —
Cold Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 72036-0155-05 Harris 12 tablets — — FDA listed —
Mucus Relief Cold Flu and Sore Throat 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 36800-0697-04 TOPCO 10 tablets — — FDA listed —
Cold and Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 41250-0663-05 Meijer 12 tablets — — Discontinued —
mucus relief sinus pressure, pain and cough 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 41250-0979-02 Meijer 10 tablets — — Discontinued —
Mucus Relief Cold and Flu All in One 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 53943-0198-04 DISCOUNT 10 tablets — — FDA listed —
Severe Cold and Flu 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 63868-0003-24 Chain 12 tablets — — Discontinued —
DayQuil Severe plus VapoCOOL Cold and Flu, CVP HEALTH 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 66715-6580-02 Lil' 2 tablets — — FDA listed —
Mucus Relief Cold and Flu all in one 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 68016-0625-20 CHAIN 10 tablets — — Discontinued —
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTION 325 mg/1; 10 mg/1; 200 mg/1; 5 mg 69423-0987-02 The 2 tablets — — FDA listed —
TYLENOL Cold Plus Flu Severe 325 mg/1; 10 mg/1; 200 mg/1; 5 mgthis 85237-1956-03 Select 2 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

🏛️
2011
On the market since
Sep 2011
📍
2026
Currently FDA-listed
15 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.

What it looks like

Color yellow
ShapeOval
ImprintTYLENOL;SEVERE
Size19 mm
ScoringNot scored
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 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 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 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 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • 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 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.

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

The official label also statescarnauba wax, croscarmellose sodium, D&C yellow no. 10 aluminum lake, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, 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.

Manufacturer & labeler

LabelerSelect Consumer Group
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code85237
First marketedSep 2011
Product typeHuman Otc Drug
Portfolio21 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.

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 36 words ▾

Uses for the temporary relief of the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 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. 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, chronic bronchitis 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.

📦 Storage and Handling 22 words ▾

Other information each caplet contains: sodium 3 mg store between 20-25°C (68-77°F) do not use if blister unit is torn or broken

🧪 Active Ingredient 28 words ▾

Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients carnauba wax, croscarmellose sodium, D&C yellow no. 10 aluminum lake, flavor, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sucralose, titanium dioxide

🎯 Purpose 28 words ▾

Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Guaifenesin 200 mg Expectorant Phenylephrine HCl 5 mg Nasal decongestant

📄 Do Not Use 95 words ▾

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 48 words ▾

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, chronic bronchitis or emphysema cough that occurs with too much phlegm (mucus)

📄 Ask a Doctor or Pharmacist Before Use If 16 words ▾

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

📄 When Using This Product 9 words ▾

When using this product do not exceed recommended dose

📄 Stop Use and Ask a Doctor If 61 words ▾

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 10 words ▾

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

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Questions or Comments 9 words ▾

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

📄 Package Label / Principal Display Panel 4 words ▾

PRINCIPAL DISPLAY PANEL 1956-1

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Select Consumer Group. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 2 tablets (85237-1956-01), 2 tablets (85237-1956-02), 2 tablets (85237-1956-04). 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?
Select Consumer Group 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.
← 85237-1955-01 · Select 85237-1960-01 · Select →
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.