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Maximum Strength Mucinex Fast-Max Cold and Flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL Solution, 266 mL — NDC 63824-0548-69 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Maximum Strength Mucinex Fast-Max Cold and Flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL Solution, 266 mL — NDC 63824-548-69 (Billing 63824-0548-69)

by Reckitt Benckiser LLC · 266 mL in 1 BOTTLE

This is a package of 266 mL of Maximum Strength Mucinex Fast-Max Cold and Flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL Solution from Reckitt Benckiser LLC, marketed since Jul 2018 and currently FDA-listed.

NDC 63824-0548-69
🏷️ FDA NDC (as labeled) 63824-548-69 billing pads the product segment with a zero
This package
Contains266 mL Pack sizes4 compare ↓
Product page 63824-0548-66 Also comes in: 118 mL 63824-548-64 3 bottles 63824-548-33 180 ml 63824-548-66
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

NDC database record

One package, one record: these facts belong to NDC 63824-548-69 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
63824 labeler · 548 product · 69 package
Package marketed since
Jul 28, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
266 mL per package
Barcode (UPC)
0363824020662
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63824-548-69
Product NDC 63824-548
11-digit billing NDC 63824054869
NCPDP billing unit ML — per mL (volume)
RxCUI 1116572
UNII 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
UPC 0363824020662
Application # M012
SPL Set ID 182222b5-a852-4dbe-b05f-a41d89806021
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 2018-07-28
Route ORAL
Dosage form SOLUTION
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 43998304100915
GPI class Mucinex Fast-Max Cold Flu
GCN Seq No 067926
GCN 30577
HICL code 035445
Ingredient (HICL) Phenylephrine/Dm/Acetaminop/Gg
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B4
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.1)
HIC3 code B4P
Therapeutic class — specific (HIC3) Non-Opioid Antituss-Decongestant-Analgesic-Expect
AHFS code 12:12.04.00
AHFS class Alpha-Adrenergic Agonists (12:12)
FDB label name MUCINEX FAST-MAX COLD-FLU LIQ
FDB brand name Mucinex Fast-Max Cold-Flu
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 067926
  • GCN: 30577
  • GPI-14 (Medi-Span): 43998304100915
  • HICL (First Databank): 035445
  • AHFS class code: 12:12.04.00
  • RxCUI (RxNorm): 1116572
Why two NDCs? The FDA registers this code as 63824-548-69 — 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 → 63824-0548-69. 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

Label name MUCINEX FAST-MAX COLD-FLU LIQ Ingredient Phenylephrine/Dm/Acetaminop/Gg
🧪 What is this product?

Maximum Strength Mucinex Fast-Max Cold and Flu is an over-the-counter oral liquid solution marketed under FDA's OTC monograph rules. It contains four active ingredients typically used together for cold and flu symptom relief: acetaminophen, commonly used to reduce fever and relieve pain; dextromethorphan, typically used to suppress cough; guaifenesin, an expectorant commonly used to help thin mucus and make coughs more productive; and phenylephrine, typically used as a nasal decongestant. This combination product is intended for multi-symptom cold and flu relief.

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.
Try another pack size: 118 mL 3 bottles 180 ml
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 Per unit Per pack Marketing startMarketing endStatus
63824-0548-64 63824-548-64 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE — — 2018-10-01 — Active
63824-0548-66 63824-548-66 Main listing 180 mL in 1 BOTTLE $0.0614 / mL $11.05 2018-07-28 — Active
63824-0548-69 You're viewing this 266 mL in 1 BOTTLE — — 2018-07-28 — Active
63824-0548-33 63824-548-33 3 BOTTLE in 1 CARTON / 180 mL in 1 BOTTLE — — 2023-08-01 — Active

Pack size FAQ

What quantity is in this package?
This package contains 266 mL — 266 ml in 1 bottle.
How does this package differ from NDC 63824-0548-66?
Both are Maximum Strength Mucinex Fast-Max Cold and Flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL Solution — the drug itself is identical. This page's package is the 266 mL one, while NDC 63824-0548-66 is the 180 ml package.
What NDC number is used to bill for this package of Maximum Strength Mucinex Fast-Max Cold and Flu acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride 650 mg/20mL; 20 mg/20mL; 400 mg/20mL; 10 mg/20mL Solution?
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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

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/20mL 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/20mLthis 63824-0548-69 Reckitt 266 ml — — 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

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 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
FlavorFruit
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 3VRD35U26C
    A natural extract from licorice root, ammonium glycyrrhizate is used as a flavoring agent and sweetener in medicines. It may also help soothe irritated tissues in the mouth or throat.
  • 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 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • 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 8D4SNN7V92
    Propyl gallate is a synthetic antioxidant derived from gallic acid. It prevents oils and fats in the medicine from oxidizing and spoiling, helping the product stay stable and effective during storage.
  • 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 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate may contain this ingredient, xanthan gum

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

LabelerReckitt Benckiser LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code63824
First marketedJul 2018
Product typeHuman Otc Drug
Portfolio174 products on file

More NDCs from Reckitt Benckiser LLC labeler code 63824

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 49 words ▾

Uses temporarily relieves these common cold and flu symptoms: cough nasal congestion minor aches and pains sore throat headache stuffy nose sinus congestion and pressure 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 72 words ▾

Directions do not take more than directed (see Overdose warning ) do not take more than 6 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and over: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use

⚠️ Warnings ~2 min read ▾

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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. Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease 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 use more than directed 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 fever, 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.

Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 16 words ▾

Other information each 20 mL contains: sodium 12 mg store at 20-25°C (68-77°F) do not refrigerate

🧪 Active Ingredient 29 words ▾

Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg Nasal decongestant

🧪 Inactive Ingredients 40 words ▾

Inactive ingredients ammonium glycyrrhizate, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40, flavor, glycerin (soy), propyl gallate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, trisodium citrate dihydrate may contain this ingredient , xanthan gum

🎯 Purpose 29 words ▾

Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Guaifenesin 400 mg Expectorant Phenylephrine HCl 10 mg 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 48 words ▾

Ask a doctor before use if you have liver disease heart disease diabetes high blood pressure thyroid disease 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 10 words ▾

When using this product do not use more than directed

📄 Stop Use and Ask a Doctor If 62 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 fever, 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 13 words ▾

Questions? 1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.

📄 Package Label / Principal Display Panel 67 words ▾

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton NDC 63824‐548‐64 MAXIMUM STRENGTH Mucinex® FAST-MAX ® COLD & FLU Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Guaifenesin – Expectorant Phenylephrine HCl – Nasal Decongestant HEADACHE BODY PAIN SORE THROAT FEVER CHEST CONGESTION COUGH ALL IN ONE* NASAL CONGESTION SINUS CONGESTION SINUS PRESSURE 4 FL OZ (118 mL) FOR AGES 12+ full carton label back label

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 Reckitt Benckiser LLC. 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 3 other package presentations of this same product, including 1 bottle (63824-0548-64), 3 bottles (63824-0548-33), 180 ml (63824-0548-66). 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?
Reckitt Benckiser LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63824-0540-66 · Reckitt 63824-0553-90 · RB →
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.