Home › NDC Lookup › Ingredients › Acetaminophen Dextromethorphan Hbr Guaif... › 00363-8005-45
Cold, Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL Solution, 177 mL — NDC 00363-8005-45 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cold, Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL Solution, 177 mL — NDC 0363-8005-45 (Billing 00363-8005-45)

by Walgreen Company · 177 mL in 1 BOTTLE, PLASTIC

This is a package of 177 mL of Cold, Flu and Sore Throat Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL Solution from Walgreen Company, marketed since Oct 2023 and currently FDA-listed. It is this product's only package size.

NDC 00363-8005-45
🏷️ FDA NDC (as labeled) 0363-8005-45 billing pads the labeler segment with a zero
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) 0363-8005-45
Product NDC 0363-8005
11-digit billing NDC 00363800545
RxCUI 1116572
UNII 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
UPC 0311917034119
Application # M012
SPL Set ID 3666cf90-54f8-4bd0-a1de-f77c97f1c045
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 2023-10-04
Route ORAL
Dosage form SOLUTION
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1116572
Why two NDCs? The FDA registers this code as 0363-8005-45 — a 4-4-2 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 labeler segment → 00363-8005-45. 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 oral liquid combination product marketed under FDA's OTC monograph rules. It contains acetaminophen, a pain reliever and fever reducer; dextromethorphan, a cough suppressant; guaifenesin, an expectorant that helps thin mucus; and phenylephrine, a nasal decongestant. The product is typically used to relieve multiple cold and flu symptoms including cough, congestion, sore throat pain, and fever.

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 mLPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00363-8005-45 You're viewing this Main listing 177 mL in 1 BOTTLE, PLASTIC 2023-10-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
leader tussin cf 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 70000-0623-01 Cardinal 1 bottle $0.024 — Availability likely —
Mucinex Fast-Max Cold, Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63824-0015-66 Reckitt 180 ml $0.061 — FDA listed —
Maximum Strength Mucinex Fast-Max Cold and Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63824-0527-03 Reckitt 180 ml $0.061 — FDA listed —
Mucinex Childrens Multi-Symptom Cold and Sore Throat 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 63824-0952-17 Reckitt 1 bottle $0.067 — FDA listed —
Mucinex Childrens FreeFrom Multi-Symptom Cold, Flu and Sore Throat 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 63824-0958-64 Reckitt 1 bottle $0.067 — FDA listed —
Robitussin Severe Multi-Symptom Cough Cold Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00031-8751-12 Haleon 1 bottle — — FDA listed —
Mucus Relief Maximum StrengthCold Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-0782-06 Walgreens 177 ml — — FDA listed —
Mucus Relief All in One Maximum Strength 20 mg/20mL; 650 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-0886-06 Walgreens 177 ml — — FDA listed —
Mucus Relief Cold Flu Sore Throat Maximum Strength 20 mg/20mL; 650 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-3361-06 Walgreens 177 ml — — FDA listed —
Cough Cold and Sore Throat Childrens 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 00363-4050-04 Walgreens 1 bottle — — FDA listed —
Walgreen Severe Multi-Symptom Cough Cold Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-6300-08 WALGREENS 1 bottle — — FDA listed —
Cold, Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mLthis 00363-8005-45 Walgreen 177 ml — — FDA listed —
Cold and Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 00363-9042-45 Walgreen 177 ml — — FDA listed —
Mucus Relief Severe Cold Daytime Maximum Strength 20 mg/20mL; 650 mg/20mL; 400 mg/20mL; 10 mg/20mL 11673-0410-06 TARGET 177 ml — — FDA listed —
Target Maximum Strength Cold Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 11673-0773-06 TARGET 180 ml — — FDA listed —
tussin severe cough cold flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 11822-1400-00 Rite 1 bottle — — Discontinued —
Cold Flu and Sore Throat Relief Maximum Strength 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 21130-0036-06 Safeway, 177 ml — — FDA listed —
COLD, FLU and SORE THROAT RELIEF 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 21130-0909-03 BETTER 177 ml — — FDA listed —
Complete Cold Relief 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 27854-0299-00 Belmora 177 ml — — FDA listed —
Maximum Strength Cold Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 30142-0731-06 KROGER 180 ml — — FDA listed —
MAX Cold, Flu, and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 37808-0316-25 H 117 ml — — FDA listed —
Mucus Relief Cough Cold Sore Throat 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 37808-0811-40 H 1 bottle — — FDA listed —
Mucus Relief Cold Flu and Sore Throat Maximum Strength 20 mg/20mL; 650 mg/20mL; 400 mg/20mL; 10 mg/20mL 41163-0035-06 United 177 ml — — FDA listed —
Maximum Strength Mucus Relief Cold,Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 41163-0737-06 SUPERVALU 180 ml — — FDA listed —
Mucus Relief Cold Flu and Sore Throat Maximum Strength 20 mg/20mL; 650 mg/20mL; 400 mg/20mL; 10 mg/20mL 49035-0336-06 EQUATE 177 ml — — FDA listed —
Maximum Strength Mucus Relief Cold,Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 49035-0771-09 Wal-Mart 266 ml — — FDA listed —
Tukol Max Action Cold, Flu and Sore Throat 32.5 mg/mL; 1 mg/mL; 20 mg/mL; .5 mg/mL 50066-0313-06 Genomma 1 bottle — — FDA listed —
Tukol MAX ACTION Cold, Sore Throat and Cough 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 50066-0516-25 Genomma 177 ml — — FDA listed —
Childrens Tukol Multi-Symptom Cold and Flu 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 50066-0519-24 Genomma 118 ml — — FDA listed —
severe tussin cf 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 51316-0323-26 CVS 1 bottle — — FDA listed —
CVS Severe Multi-Symptom Cough Cold Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 51316-0630-04 CVS 1 bottle — — FDA listed —
Tussnex FM Cold, Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 53041-0618-58 Guardian 177 ml — — FDA listed —
Mucosan Max with Acetaminophen 650 mg/20mL; 400 mg/20mL; 20 mg/20mL; 10 mg/20mL 53145-0696-06 Menper 1 bottle — — FDA listed —
Cold, Flu and Sore Throat Maxium Strength 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 53942-0516-25 DeMoulas 177 ml — — FDA listed —
Cold, Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 55319-0705-45 Family 177 ml — — FDA listed —
SanaTos X Children 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 55758-0443-04 Pharmadel 1 bottle — — FDA listed —
Mucus Relief Cold Flu and Sore Throat Maximum Strength 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 55910-0336-09 Dolgencorp, 266 ml — — FDA listed —
dg health tussin 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 55910-0398-26 Dolgencorp 1 bottle — — FDA listed —
Mucus Relief All in One Maximum Strength 20 mg/20mL; 650 mg/20mL; 400 mg/20mL; 10 mg/20mL 55910-0886-06 Dolgencorp, 177 ml — — FDA listed —
tussin severe 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 59640-0010-26 H 1 bottle — — FDA listed —
Maximum Strength Mucinex Fast-Max Cold and Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63824-0548-64 Reckitt 1 bottle — — FDA listed —
Mucinex Childrens Cold and Flu 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 63824-0954-04 Reckitt 1 bottle — — FDA listed —
Mucus Relief Cold Flu and Sore Throat Maximum Strength 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 63868-0746-07 QUALITY 177 ml — — Discontinued —
WINCO Maximum StrengthCold Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 67091-0457-06 WINCO 180 ml — — FDA listed —
Mucus Relief Cold Flu and Sore Throat Maximum Strength 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 68163-0737-09 Raritan 266 ml — — FDA listed —
Multi-Symptom Cold and Fever Childrens 325 mg/10mL; 10 mg/10mL; 200 mg/10mL; 5 mg/10mL 69842-0475-36 CVS 1 bottle — — FDA listed —
CVS Maximum Strength Cold and Flu Relief 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 69842-0566-06 CVS 180 ml — — FDA listed —
CVS Maximum Strength Cold and Flu Relief 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 69842-0903-06 CVS 180 ml — — FDA listed —
basic care tussin cf severe 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 72288-0463-34 Amazon.com 1 bottle — — FDA listed —
Mucinex Fast-Max Kickstart Severe Cold and Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 72854-0138-66 RB 180 ml — — FDA listed —
topcare tussin cf max 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 76162-0000-26 Topco 1 bottle — — FDA listed —
Mucus Relief Cold, Flu and Sore Throat 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 76162-0050-45 TOPCO 177 ml — — FDA listed —
Meijer Adult Severe Multi-Symptom Cough Cold Flu 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL 79481-6300-08 MEIJER 1 bottle — — FDA listed —
Maximum Strength Mucus Relief 20 mg/20mL; 400 mg/20mL; 10 mg/20mL; 650 mg/20mL 83324-0143-06 Chain 177 ml — — 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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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 blue
FlavorBerry
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 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 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 PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 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 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 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 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the 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 B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesanhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose

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

LabelerWalgreen Company
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedOct 2023
Product typeHuman Otc Drug
Portfolio468 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 55 words ▾

Uses temporarily relieves these common cold and flu symptoms: minor aches and pains sinus congestion and pressure stuffy nose nasal congestion sore throat cough headache temporarily promotes nasal and/or sinus drainage temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

⏱️ Dosage and Administration 59 words ▾

Directions do not take more than directed do not take more than 6 doses in any 24-hour period mL = milliliter only use the dose cup provided dose as follows or as directed by a doctor adults and children 12 years and over: 20 mL in dosing cup provided every 4 hours children under 12 years: do not use

⚠️ Warnings ~2 min read ▾

Warnings Liver warning: This product contains acetaminophen. 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: rash blisters skin reddening 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. Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) liver disease heart disease diabetes difficulty in urination due to enlargement of the prostate gland high blood pressure persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema thyroid disease 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 pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur nervousness, dizziness, or sleeplessness occur fever gets worse or lasts more than 3 days redness or swelling is present 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. In case of overdose, get medical help or contact a Poison Control Center right away.

Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 24 words ▾

Other information each 20 mL contains: sodium 10 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) use by expiration date on package

🧪 Active Ingredient 20 words ▾

Active ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg Phenylephrine HCl 10 mg

🧪 Inactive Ingredients 28 words ▾

Inactive ingredients anhydrous citric acid, FD&C blue #1, FD&C red #40, flavors, glycerin, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sodium metabisulfite, sorbitol, sucralose

🎯 Purpose 9 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

📄 Do Not Use 79 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.

📄 Ask a Doctor Before Use If 50 words ▾

Ask a doctor before use if you have cough that occurs with too much phlegm (mucus) liver disease heart disease diabetes difficulty in urination due to enlargement of the prostate gland high blood pressure persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema thyroid disease

📄 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 dosage.

📄 Stop Use and Ask a Doctor If 61 words ▾

Stop use and ask a doctor if pain, nasal congestion, or cough gets worse or lasts more than 7 days new symptoms occur nervousness, dizziness, or sleeplessness occur fever gets worse or lasts more than 3 days redness or swelling is present 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 43 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-426-9391

📄 Package Label / Principal Display Panel 171 words ▾

Principal Display Panel Walgreens WALGREENS PHARMACIST RECOMMENDED † Compare to the active ingredients in Maximum Strength Mucinex® FAST-MAX® Cold, Flu & Sore Throat †† Cold, Flu & Sore Throat ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT GUAIFENESIN / EXPECTORANT PHENYLEPHRINE HCl / NASAL DECONGESTANT Maximum Strength • Relieves body pain, headache, fever & sore throat • Controls cough • Relieves nasal & chest congestion • Thins & loosens mucus • Ages 12 years & over 6 FL OZ (177 mL) TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org 50844 REV0724A00545 DISTRIBUTED BY: WALGREEN CO.

DEERFIELD, IL 60015 100% SATISFACTION GUARANTEED walgreens.com ©2025 Walgreen Co. NDC 0363-8005-45 † Our pharmacists recommend the Walgreens brand. We invite you to compare to national brands. †† This product is not manufactured or distributed by RB Health (US) LLC, owner of the registered trademark Maximum Strength Mucinex® FAST-MAX® Cold, Flu & Sore Throat.

Walgreens 44-005 Walgreens 44-005

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

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 Cold, Flu and Sore Throat (this brand).

Top reported reactions

Toxicity To Various Agents2
Anaphylactic Reaction1
Choking1
Erythema1
Heart Rate Increased1
Intentional Product Misuse1
Peripheral Swelling1

Age at onset

Adult2

Reporter sex

6 reports
Male · 33%
Female · 67%

Serious outcomes

Hospitalization3
Death2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2 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.

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 Walgreen Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Walgreen Company 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.
← 00363-8004-45 · Walgreen 00363-8011-62 · Walgreen →
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.