List of Excipients in Branded Drug MUCUS RELIEF DM MAX

Generic Drugs Containing MUCUS RELIEF DM MAX

Company	Ingredient	NDC	Excipient
TARGET Corporation	dextromethorphan hbr, guaifenesin	11673-834	CARBOMER 934
TARGET Corporation	dextromethorphan hbr, guaifenesin	11673-834	CELLULOSE, MICROCRYSTALLINE
TARGET Corporation	dextromethorphan hbr, guaifenesin	11673-834	D&C YELLOW NO. 10
TARGET Corporation	dextromethorphan hbr, guaifenesin	11673-834	HYPROMELLOSE
TARGET Corporation	dextromethorphan hbr, guaifenesin	11673-834	LACTOSE MONOHYDRATE
TARGET Corporation	dextromethorphan hbr, guaifenesin	11673-834	MAGNESIUM STEARATE

What are the Most Frequently-Used Excipients in MUCUS RELIEF DM MAX?

# Of NDCs	Excipient
1	CARBOMER 934
1	CARBOMER HOMOPOLYMER TYPE B
3	CELLULOSE, MICROCRYSTALLINE
1	COPOVIDONE K25-31
2	D&C YELLOW NO. 10
3	HYPROMELLOSE

Mucus Relief DM Max Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: August 24, 2026

Mucus Relief DM Max is an over-the-counter extended-release cough-and-expectorant product combining guaifenesin and dextromethorphan hydrobromide. Its commercial position depends less on active-ingredient patents than on formulation performance, tablet manufacturability, retailer economics, brand equivalence, and regulatory compliance. The principal excipient opportunity is a robust 12-hour matrix or multiparticulate delivery system that maintains dose uniformity, controls release of both actives, limits tablet size, and supports low-cost private-label production.

What is Mucus Relief DM Max?

Mucus Relief DM Max is generally marketed as an extended-release tablet containing:

Component	Function	Typical labeled amount
Guaifenesin	Expectorant	1,200 mg
Dextromethorphan hydrobromide	Antitussive	60 mg
Dosage form	Extended-release oral tablet	One tablet every 12 hours

The product is positioned against branded and store-brand products equivalent to Mucinex DM Maximum Strength. The combination targets productive cough and cough suppression in a single twice-daily dosage form.

The active ingredients are chemically established OTC substances. Their commercial value comes from dose, release profile, combination positioning, packaging, and retail distribution rather than new-molecule exclusivity.

What excipients are likely used in Mucus Relief DM Max?

Public OTC labels typically identify the active ingredients and may identify inactive ingredients, but they generally do not disclose quantitative excipient levels or the complete manufacturing process. A commercially practical formulation would likely use the following excipient categories:

Excipient category	Likely candidates	Technical purpose
Diluent and compression aid	Microcrystalline cellulose, silicified microcrystalline cellulose	Tablet structure and compressibility
Binder	Povidone, copovidone, hydroxypropyl cellulose	Granule strength and content uniformity
Release-control polymer	Hypromellose, ethylcellulose, methacrylate copolymers	12-hour release control
Superdisintegrant	Crospovidone, croscarmellose sodium, sodium starch glycolate	Hydration and matrix breakup
Glidant	Colloidal silicon dioxide	Powder flow
Lubricant	Magnesium stearate, sodium stearyl fumarate	Ejection and tooling protection
Opacifier or colorant	Titanium dioxide or approved color systems	Identification and appearance
Film former	Hypromellose, polyethylene glycol, polyvinyl alcohol	Swallowability and tablet protection
Antiadherent	Talc or equivalent material	Manufacturing performance

A formulation should not rely on a single excipient to control release and disintegration. The high guaifenesin load creates a large tablet and can produce poor compactability, capping, sticking, or slow dissolution if the matrix is over-polymerized.

Which excipients are most important for the formulation?

The highest-value excipient decisions concern the release-control polymer, binder system, lubricant level, and granulation route.

Guaifenesin is present at a high dose relative to dextromethorphan. The formulation therefore needs a high drug-loading strategy. Direct compression can reduce processing steps, but wet granulation may improve flow and content uniformity where the dextromethorphan fraction is small relative to guaifenesin.

Hydrophilic hypromellose is a practical starting point for a monolithic matrix. Polymer viscosity, substitution type, particle size, and loading level affect gel formation and drug diffusion. A lower-viscosity polymer can improve early release but may fail the 12-hour profile. A higher-viscosity grade can extend release but increase tablet size and risk incomplete release.

A dual-matrix approach can separate the performance requirements of the two actives. Guaifenesin may be dispersed in a hydrophilic matrix, while dextromethorphan may be incorporated into a polymer-coated granule or controlled-release layer. This approach raises manufacturing cost but can improve control of the low-dose component.

What formulation patents protect Mucus Relief DM Max?

No widely recognized active-ingredient patent estate protects the guaifenesin and dextromethorphan combination itself. The principal intellectual-property value is likely to reside in formulation, manufacturing, packaging, or brand-specific trade dress rather than basic molecule patents.

IP category	Relevance to Mucus Relief DM Max	Expected risk level
Guaifenesin composition patents	Limited for an established OTC ingredient	Low
Dextromethorphan composition patents	Limited for an established OTC ingredient	Low
Combination-product patents	Potentially relevant if claims cover ratios or release profiles	Low to moderate
Extended-release formulation patents	Relevant to polymer systems, coated particles, or release profiles	Moderate
Manufacturing patents	Relevant to granulation, compression, coating, and scale-up	Low to moderate
Trade dress and trademarks	Relevant to retailer branding and packaging	Moderate
Orange Book-listed patents	Generally not the main barrier for a monograph OTC product	Low

A generic or private-label manufacturer must still conduct a freedom-to-operate review. A product can avoid active-ingredient claims while infringing a formulation patent directed to release kinetics, coated particles, tablet architecture, or a specific excipient combination.

What is the FDA regulatory status of Mucus Relief DM Max?

The product falls within the regulatory framework for OTC cough, cold, bronchodilator, and antiasthmatic drug products under 21 C.F.R. Part 341. Guaifenesin and dextromethorphan are established OTC monograph ingredients when used within the permitted conditions, labeling, dosage, and route requirements.[1]

The regulatory pathway is materially different from approval of a new prescription drug:

Regulatory issue	Commercial implication
OTC monograph eligibility	Reduces dependence on a new-drug approval pathway
Active ingredients	Must comply with monograph conditions or another valid FDA pathway
Extended-release dosage form	Requires product-specific performance and quality controls
Labeling	Must conform to OTC warnings, directions, and indications
Bioequivalence or comparative performance	May be required depending on product pathway and formulation
Manufacturing	Must comply with current good manufacturing practice requirements
Postmarket obligations	Include complaint handling, adverse-event reporting, and quality investigations

The monograph route does not eliminate formulation risk. An extended-release combination product must demonstrate reproducible dissolution, stability, assay, content uniformity, impurity control, and physical integrity through shelf life.

What is the Orange Book status of Mucus Relief DM Max?

Mucus Relief DM Max is not primarily an Orange Book exclusivity story. OTC monograph products generally do not receive the same patent-and-exclusivity structure associated with approved prescription products listed in the Orange Book.

The commercial barriers are instead:

1. Meeting the applicable OTC monograph conditions.
2. Establishing a stable extended-release formulation.
3. Demonstrating acceptable product performance.
4. Avoiding third-party formulation and manufacturing patents.
5. Securing retailer authorization and shelf placement.
6. Maintaining supply and quality at private-label margins.

A manufacturer should not assume that the absence of a prominent Orange Book patent listing creates unrestricted freedom to copy a branded extended-release product. Patent exposure can exist outside the Orange Book, particularly for formulation and manufacturing claims.

When does Mucus Relief DM Max lose exclusivity?

Mucus Relief DM Max does not appear to have a conventional prescription-drug exclusivity expiration date. Its market exclusivity is commercial and contractual.

Exclusivity source	Likely duration logic
New chemical entity exclusivity	Not applicable to established guaifenesin or dextromethorphan
New-drug exclusivity	Not the primary framework
Orange Book patent term	Not the principal protection mechanism
Trademark rights	Continue while maintained and used
Retailer agreement	Depends on contract and supply terms
Formulation know-how	Persists as confidential information
Private-label placement	Depends on retailer performance and pricing

Because the ingredients are established and widely available, competing manufacturers can enter with equivalent products if they meet applicable regulatory requirements and avoid enforceable third-party rights.

Which companies challenge Mucus Relief DM Max in the market?

The relevant competition is from branded and store-brand products containing the same active ingredients. Major competitive categories include:

Competitor type	Examples
National brand	Mucinex DM Maximum Strength
Retail private label	CVS Health, Walgreens, Walmart, Target, Rite Aid and regional pharmacy labels
Value generics	Perrigo, Kenvue, Teva, retailer-sourced OTC manufacturers
Alternative dosage forms	Immediate-release liquids, capsules, tablets, and combination cold products

The closest competitive benchmark is a 12-hour extended-release tablet containing 1,200 mg guaifenesin and 60 mg dextromethorphan hydrobromide. Price, tablet count, package design, retailer margin, and perceived equivalence are more important than molecule differentiation.

What excipient strategy creates the strongest commercial position?

A commercially attractive formulation should meet five objectives: high drug loading, consistent 12-hour release, low defect rates, small practical tablet size, and broad supplier availability.

Strategy 1: Hydrophilic matrix tablet

A hypromellose-based matrix is the lowest-complexity platform. It can be manufactured through direct compression or wet granulation.

Advantages include:

• Lower manufacturing complexity.
• Broad excipient availability.
• Straightforward scale-up.
• Lower bill-of-materials cost.
• Compatibility with private-label pricing.

Risks include:

• Large tablet dimensions.
• Sensitivity to compression force and polymer distribution.
• Potential burst release of dextromethorphan.
• Dissolution variability between equipment scales.

Strategy 2: Coated multiparticulate system

Guaifenesin and dextromethorphan can be layered or granulated into particles with a controlled-release coating, then compressed into a tablet or filled into a capsule.

Advantages include:

• Better control of each active ingredient.
• Reduced risk of dose dumping.
• Flexibility to combine immediate and extended-release fractions.
• Potentially improved pharmacokinetic matching.

Risks include:

• Higher coating and analytical costs.
• Greater process complexity.
• More demanding scale-up.
• Increased risk of patent overlap.
• Higher capital requirements.

Strategy 3: Bilayer or multilayer tablet

A bilayer design can place different release systems in separate tablet layers. One layer can support guaifenesin release, while the other controls dextromethorphan.

Advantages include:

• Physical separation of incompatible excipient systems.
• More precise release engineering.
• Clear manufacturing control points.

Risks include:

• Layer separation and delamination.
• Higher tooling and compression complexity.
• Increased tablet size.
• More expensive validation.

For a mass-market store-brand product, the hydrophilic matrix is generally the most attractive starting platform. Multiparticulate or bilayer systems become more compelling where dissolution performance, patent differentiation, or product line extension justifies the cost.

What formulation improvements could create commercial opportunities?

The strongest opportunities are product extensions rather than a new active ingredient.

Opportunity	Value proposition	Commercial potential
Smaller tablet	Easier swallowing	High
Lower-cost 12-hour tablet	Retailer margin and consumer value	High
Sugar-free liquid	Pediatric or swallowing-constrained users where permitted	Moderate
Alcohol-free liquid	Broader household acceptability	Moderate
Combination pack	Cough and congestion regimen	Moderate
Gelcap or capsule	Easier ingestion and differentiation	Moderate
Tamper-evident unit dose	Safety and institutional use	Low to moderate
Senior-friendly packaging	Accessibility and adherence	Moderate
Fast-dissolving or orally disintegrating form	Convenience	Technically difficult
Dual-release profile	Better cough suppression and expectoration timing	High but technically demanding

Excipient suppliers can capture value by offering ready-to-use direct-compression blends, high-functionality hypromellose grades, low-level lubricants, co-processed fillers, and film-coating systems optimized for high-dose OTC tablets.

A supplier with dissolution-modeling capability can differentiate through formulation support rather than commodity excipient pricing. The commercial pitch should focus on fewer development cycles, lower tablet weight, improved tooling performance, and reliable release profiles.

What manufacturing and IP barriers affect generic entry?

The main manufacturing barriers are operational rather than chemical.

High-dose tablet compression

Guaifenesin accounts for most of the tablet mass. High drug loading can cause:

• Poor powder flow.
• Segregation of the low-dose dextromethorphan component.
• Tablet capping.
• Punch sticking.
• Weight variation.
• Slow disintegration or incomplete release.

Dissolution control

The product must maintain its release profile across:

• Different raw-material lots.
• Compression-force ranges.
• Equipment scales.
• Storage conditions.
• Physiological pH conditions.
• Packaging configurations.

A formulation that passes development dissolution may fail after commercial scale-up if polymer hydration, granule density, or tablet porosity changes.

Supply-chain resilience

The preferred excipient platform should have at least two qualified suppliers for critical materials. Hypromellose, microcrystalline cellulose, magnesium stearate, film-coating components, and printing inks can affect production continuity and release performance.

Confidential know-how

Manufacturing parameters may be more valuable than patent claims. Important know-how includes:

• Order of excipient addition.
• Granulation endpoint.
• Lubrication time.
• Compression-force window.
• Coating weight gain.
• Hold times.
• Packaging moisture controls.
• In-process dissolution specifications.

What patent litigation or settlement risks affect Mucus Relief DM Max?

The product category has lower litigation exposure than patented prescription combinations, but three risks remain:

1. A formulation patent may claim a specific extended-release matrix or multiparticulate architecture.
2. A branded manufacturer may assert trade dress or trademark rights against confusingly similar packaging.
3. A supplier agreement may restrict use of proprietary excipient systems or technical data.

Paragraph IV litigation is generally not the central entry mechanism for an OTC monograph product. A manufacturer seeking entry should focus on patent clearance, regulatory compliance, trademark screening, and comparative product performance.

No biosimilar risk applies. Mucus Relief DM Max is a small-molecule OTC product, not a biologic. Biosimilar approval pathways under the Public Health Service Act are irrelevant to this product.[2]

How does Mucus Relief DM Max compare with Mucinex DM Maximum Strength?

Attribute	Mucus Relief DM Max	Mucinex DM Maximum Strength
Active ingredients	Guaifenesin and dextromethorphan hydrobromide	Same therapeutic combination
Typical strength	1,200 mg / 60 mg	1,200 mg / 60 mg
Release	Extended release	Extended release
Main differentiation	Retailer price, package, availability	Brand recognition and consumer trust
Patent value	Likely limited at molecule level	Primarily formulation, brand, and know-how
Generic entry	Feasible under OTC framework	Feasible if regulatory and IP requirements are met
Key commercial constraint	Retailer economics and supply	Brand premium and shelf competition

The store-brand product can compete effectively when it matches the branded product in tablet size, dosing interval, appearance, package count, and perceived performance. A technically equivalent product can still lose shelf space if it has higher tablet defects, poor packaging, or inconsistent supply.

What revenue exposure and commercial upside exist?

Product-specific revenue for Mucus Relief DM Max is not generally disclosed separately by retailers or contract manufacturers. The opportunity should be assessed through category economics:

• Annual respiratory-season demand.
• Retailer private-label penetration.
• Gross margin per package.
• Wholesale acquisition cost.
• Package count and dosage frequency.
• Out-of-stock rates.
• Promotional elasticity.
• Manufacturing yield.
• Product returns and complaint rates.

The highest-value opportunity is a reliable, low-cost product that can be supplied across multiple retail channels. Margin expansion is more likely to come from process yield, reduced tablet weight, lower coating cost, and dual-source excipients than from a novel active formulation.

Geographic expansion is relatively straightforward where guaifenesin and dextromethorphan are permitted OTC ingredients, but labeling, dosage conventions, excipient restrictions, and local registration requirements vary by jurisdiction. The United States is the most direct opportunity because the product aligns with the FDA OTC monograph framework. Canada, the European Union, and other markets require separate regulatory and labeling analysis.

Key Takeaways

• Mucus Relief DM Max is an extended-release guaifenesin and dextromethorphan OTC product, typically dosed at 1,200 mg and 60 mg every 12 hours.
• Its commercial protection is not primarily based on molecule patents or prescription-style exclusivity.
• A hypromellose matrix tablet is the most practical cost-focused formulation platform.
• Multiparticulate and bilayer systems offer stronger release control but increase cost and potential patent exposure.
• The main technical challenge is controlling a low-dose dextromethorphan component within a high-dose guaifenesin tablet.
• Generic and private-label entry is commercially feasible, subject to OTC monograph compliance, product-performance testing, trademark clearance, and formulation freedom to operate.
• No biosimilar pathway or conventional Paragraph IV strategy is central to this product.
• The strongest commercial opportunities are smaller tablets, reliable 12-hour release, lower-cost private-label supply, liquid extensions, and excipient systems that improve manufacturability.

FAQs

Is Mucus Relief DM Max protected by a new chemical entity patent?

No. Guaifenesin and dextromethorphan are established active ingredients. Any meaningful protection would more likely involve formulation, manufacturing, trademarks, packaging, or confidential know-how.

Can a manufacturer make a generic equivalent of Mucus Relief DM Max?

Yes, provided the product satisfies the applicable FDA OTC requirements, matches the required active-ingredient conditions, meets quality and performance standards, and avoids enforceable third-party intellectual-property rights.

Which polymer is most suitable for a 12-hour Mucus Relief DM Max tablet?

Hypromellose is a practical first-line polymer for a hydrophilic matrix. The grade and concentration must be optimized against tablet size, dissolution, compression behavior, and release of both active ingredients.

Is dextromethorphan a controlled substance in the United States?

Federal law does not classify dextromethorphan as a controlled substance, but state restrictions, age limits, retail controls, and abuse-prevention measures can apply.

Can excipient selection support premium pricing in this product category?

Usually only indirectly. Excipient value is strongest when it reduces tablet size, improves swallowing, stabilizes the release profile, lowers defect rates, supports dual sourcing, or reduces total manufacturing cost.

References

1. U.S. Food and Drug Administration. (2024). 21 C.F.R. Part 341: Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. Electronic Code of Federal Regulations.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA Orange Book.

3. U.S. Food and Drug Administration. (2024). Current good manufacturing practice requirements for finished pharmaceuticals, 21 C.F.R. Parts 210 and 211. Electronic Code of Federal Regulations.

4. U.S. Food and Drug Administration. (2024). Inactive ingredient database. FDA.

5. U.S. Food and Drug Administration. (2024). Over-the-counter monograph drug products. FDA.