List of Excipients in Branded Drug MUCUS RELIEF EXTENDED RELEASE

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Generic Drugs Containing MUCUS RELIEF EXTENDED RELEASE

Company	Ingredient	NDC	Excipient
Walgreens	guaifenesin	0363-0832	CARBOMER 934
Walgreens	guaifenesin	0363-0832	CELLULOSE, MICROCRYSTALLINE
Walgreens	guaifenesin	0363-0832	FD&C BLUE NO. 1
Walgreens	guaifenesin	0363-0832	HYPROMELLOSE
Walgreens	guaifenesin	0363-0832	LACTOSE MONOHYDRATE
Walgreens	guaifenesin	0363-0832	MAGNESIUM STEARATE
Walgreens	guaifenesin	0363-0832	POVIDONE

What are the Most Frequently-Used Excipients in MUCUS RELIEF EXTENDED RELEASE?

# Of NDCs	Excipient
17	CARBOMER 934
17	CELLULOSE, MICROCRYSTALLINE
17	FD&C BLUE NO. 1
17	HYPROMELLOSE
17	LACTOSE MONOHYDRATE
17	MAGNESIUM STEARATE
17	POVIDONE

Mucus Relief Extended Release: Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: October 10, 2026

Mucus Relief Extended Release is an OTC guaifenesin extended-release product category. Its commercial value depends less on active-ingredient exclusivity and more on reliable 12-hour drug release, low-cost tablet manufacturing, acceptable swallowability, retailer access, and differentiated packaging. Guaifenesin is an established expectorant covered by the FDA OTC monograph framework rather than a conventional prescription-drug exclusivity model.[1]

The strongest commercial opportunities are retailer-brand supply, private-label manufacturing, formulation improvements, smaller-dose or easier-to-swallow presentations, and supply-chain advantages. The principal technical risks are dissolution variability, tablet size, moisture sensitivity, mechanical damage during coating or packaging, and failure to demonstrate an extended-release profile across the product shelf life.

What is Mucus Relief Extended Release?

Mucus Relief Extended Release generally refers to an oral guaifenesin tablet designed to release drug over approximately 12 hours. Commercial products are commonly sold in 600 mg and 1,200 mg strengths, although strength, labeler, packaging, and inactive ingredients vary by manufacturer and National Drug Code.

Attribute	Commercial assessment
Active ingredient	Guaifenesin
Therapeutic category	OTC expectorant
Dosage form	Extended-release oral tablet
Typical dosing concept	Every 12 hours
Main consumer use	Relief of chest congestion and loosening of phlegm
Regulatory pathway	OTC monograph framework
Primary technical challenge	Controlling release over the labeled dosing interval
Primary economic challenge	Low-cost competition and retailer pricing
Orange Book relevance	Generally limited for OTC monograph products
Biosimilar relevance	None
Paragraph IV relevance	Generally none unless a separate NDA-listed product is involved

The product should be analyzed as a guaifenesin ER platform rather than as a single global product. The exact labeler and formulation cannot be inferred from the product name alone.

What excipients are used in guaifenesin extended-release tablets?

The core excipient strategy is usually a hydrophilic matrix, a coated multiparticulate system, or a combination of matrix and coating technologies. Public labels for individual products identify inactive ingredients, but those ingredients do not necessarily reveal the manufacturing process or release-control mechanism.

Typical excipient functions

Excipient class	Typical examples	Function in the formulation
Hydrophilic polymer	Hypromellose, also called HPMC	Forms a hydrated gel layer that slows drug diffusion and erosion
Diluent	Microcrystalline cellulose, lactose, dibasic calcium phosphate	Provides tablet mass, compressibility, and dose uniformity
Binder	Povidone, pregelatinized starch, hydroxypropyl cellulose	Improves granule and tablet strength
Disintegrant	Crospovidone, sodium starch glycolate, croscarmellose sodium	Supports breakup of non-rate-controlling portions of the tablet
Lubricant	Magnesium stearate, stearic acid	Reduces sticking and ejection force
Glidant	Colloidal silicon dioxide	Improves powder flow
Film-coating system	Hypromellose, polyvinyl alcohol, polyethylene glycol, titanium dioxide, colorants	Improves appearance, handling, light protection, and swallowability
Taste and odor modifiers	Flavor systems or coating components	Can reduce the sensory impact of the active and excipients
Moisture-control components	High-barrier blister or bottle packaging, desiccant where justified	Protects dissolution performance and tablet mechanics

A hydrophilic HPMC matrix is commercially attractive because it uses common pharmaceutical excipients, is scalable by direct compression or wet granulation, and can be adjusted through polymer viscosity, concentration, particle size, and tablet geometry.

Which excipient strategy is strongest for Mucus Relief Extended Release?

A robust development strategy would begin with a hydrophilic matrix tablet using HPMC as the principal release-controlling polymer. The formulation should be designed around release kinetics, not simply around a target polymer percentage.

Option 1: HPMC matrix tablet

This is usually the lowest-cost development path.

Advantages include:

• Straightforward tablet manufacturing
• Broad supplier availability
• Low dependence on specialized coating equipment
• Ability to tune release by polymer grade and loading
• Compatibility with high-dose guaifenesin products

Risks include:

• Large tablet size because guaifenesin is administered at a relatively high dose
• Sensitivity to compression force and tablet porosity
• Faster release if the matrix hydrates inconsistently
• Dissolution shifts after exposure to heat or humidity
• Potential food-effect or agitation sensitivity

A matrix system should be evaluated across multiple HPMC viscosity grades. Lower-viscosity polymers may improve manufacturability but can produce faster release. Higher-viscosity polymers can extend release but may increase tablet size, gel strength, and manufacturing sensitivity.

Option 2: Coated multiparticulates

Guaifenesin can be layered or granulated into pellets, followed by application of a polymeric rate-controlling coating.

Advantages include:

• More precise release control
• Reduced dependence on tablet porosity
• Potential for smaller subunits and flexible dosage forms
• Better ability to create sprinkle or alternative administration products

Risks include:

• Higher manufacturing cost
• More complex process validation
• Coating-weight variability
• Greater equipment and scale-up requirements
• More demanding dissolution specifications

Multiparticulate technology is most commercially attractive when it supports a meaningful product distinction, such as an easier-to-swallow product, a sprinkle formulation, or a pediatric presentation.

Option 3: Matrix plus functional film coat

A hybrid system can use an HPMC matrix for the primary release control and a thin functional coating for additional protection or release adjustment. This approach may improve robustness but increases process complexity.

It is commercially justified where the product must meet a tight dissolution profile across different tablet hardness, moisture, and storage conditions.

What excipients create the largest commercial opportunity?

The most defensible opportunity is not a new excipient by itself. It is an excipient system that lowers manufacturing cost or improves consumer use without changing the established product profile.

Polymer optimization

A supplier or manufacturer could develop a guaifenesin ER platform based on:

• Lower polymer loading
• More efficient HPMC grades
• Polymer blends that reduce tablet size
• Improved release consistency across compression-force ranges
• Lower sensitivity to gastric agitation
• Reduced batch-to-batch dissolution variation

The value proposition must be measurable. Examples include lower coating cost, higher tablet press speed, lower rejection rates, or reduced tablet dimensions.

Swallowability and tablet-size reduction

Guaifenesin ER tablets are constrained by the active dose. A formulation that reduces tablet volume while preserving the 12-hour release profile could support a premium private-label product.

Potential approaches include:

• Higher-density excipient systems
• Granulation that reduces porosity
• Multiparticulate compression
• Functional coatings that permit lower matrix-polymer loading
• Bilayer or dual-phase tablets

The regulatory and technical burden increases if the dosage form changes materially. A smaller tablet is commercially useful only if dissolution, stability, mechanical strength, and label performance remain acceptable.

Low-dust and direct-compression systems

A direct-compression formulation can reduce processing steps and improve manufacturing economics. A suitable excipient platform would need:

• Consistent flow
• Low segregation risk
• Adequate tensile strength
• Low friability
• Low sticking and picking
• Stable release after scale-up

The highest-value excipient suppliers are those able to provide a complete powder platform rather than a single polymer. This could include a co-processed filler-binder, a release-controlling polymer, and a lubricant or glidant system validated for high-dose guaifenesin tablets.

Moisture and stability control

Moisture can alter matrix hydration, tablet hardness, coating integrity, and dissolution. Commercial opportunities include:

• High-barrier bottles
• Blister packaging with improved water-vapor protection
• Desiccant-compatible packaging
• Moisture-resistant coating systems
• Excipient combinations with lower hygroscopicity

Packaging is part of the release-control strategy. A formulation that performs well only under tightly controlled humidity may create higher quality costs and greater market-complaint risk.

What is the FDA regulatory status of Mucus Relief Extended Release?

Guaifenesin is an OTC expectorant active ingredient recognized under the FDA OTC monograph system. The expectorant monograph is codified in 21 C.F.R. Part 341, including conditions for active ingredients, labeling, and dosage forms.[1]

A compliant product generally requires:

1. An eligible active ingredient and dosage form.
2. Labeling consistent with the applicable OTC monograph.
3. Manufacturing under current good manufacturing practice requirements.
4. Stability data supporting the labeled shelf life.
5. Dissolution and release testing appropriate for the extended-release dosage form.
6. Appropriate safety and performance controls for the final product.

The exact regulatory route depends on the product’s formulation, claims, dosage form, strength, and whether it falls fully within the current monograph conditions.

Does Mucus Relief Extended Release have FDA exclusivity?

OTC monograph products generally do not receive the same new-drug exclusivity periods associated with prescription NDAs. The principal commercial barrier is regulatory compliance and product quality, not a long period of market exclusivity.

A manufacturer may still own patents covering a specific formulation, manufacturing method, coating system, packaging configuration, or combination product. Those rights would be separate from the basic guaifenesin active-ingredient status.

What patents protect Mucus Relief Extended Release?

No broad patent protection should be assumed for guaifenesin itself. Guaifenesin is an established active ingredient with extensive prior use.

Potentially relevant rights may cover:

• Specific extended-release matrices
• Coated particles or granules
• Dual-release dosage forms
• Taste-masking systems
• Reduced-size tablets
• Abuse-deterrent or dose-dumping-resistant designs
• Packaging systems
• Manufacturing processes
• Combination products containing guaifenesin and another active ingredient

Patent strength depends on claim scope and expiration, not on the presence of an inactive ingredient in a product label. HPMC, microcrystalline cellulose, magnesium stearate, and common coating materials are generally weak standalone patent positions because of extensive prior art and routine pharmaceutical use.

How strong is the patent estate for guaifenesin extended-release products?

The patent estate is likely weak at the active-ingredient level and potentially moderate for a narrowly defined formulation or process.

Patent category	Likely commercial strength
Guaifenesin composition of matter	Very weak or expired
Basic HPMC matrix	Weak because of extensive prior art
Specific polymer ratio and dissolution profile	Moderate if technically distinctive
Novel multiparticulate coating	Moderate to strong if claims are narrow and validated
Tablet-size reduction platform	Moderate if supported by unexpected performance
Packaging configuration	Usually weak unless tied to a specific technical result
Manufacturing process	Moderate if difficult to design around
OTC labeling claims	Limited exclusivity value

A freedom-to-operate review should search formulation patents, continuations, abandoned applications, and foreign equivalents. Product-name searching alone is insufficient because the marketed name may be owned by a retailer or labeler rather than the formulation developer.

What is the Orange Book status of Mucus Relief Extended Release?

The Orange Book is primarily relevant to approved prescription and certain nonprescription drug applications. A conventional OTC monograph product is not generally protected through Orange Book-listed patents in the same way as an NDA product.

Issue	Assessment
Orange Book listing	Not generally expected for a monograph guaifenesin product
Paragraph IV certification	Generally not applicable to a monograph-only product
ANDA substitution	Not the primary market-entry mechanism for a monograph product
OTC monograph compliance	Central regulatory pathway
Patent litigation risk	More likely to involve private formulation or process rights than Orange Book litigation

If a particular Mucus Relief Extended Release SKU is marketed under an approved NDA or other listed application, its status must be assessed separately. The trade name alone does not establish the application pathway.

When does Mucus Relief Extended Release lose exclusivity?

There is no single loss-of-exclusivity date for the product category. Guaifenesin has long been available in OTC products, and competing products can enter when they comply with the applicable monograph and quality requirements.

The commercial exclusivity timeline is therefore:

Milestone	Commercial effect
Guaifenesin active ingredient established	No meaningful active-ingredient exclusivity
OTC monograph availability	Enables compliant competing products
Brand launch	Creates retail and consumer recognition
Private-label entry	Applies price pressure
Formulation patent expiration	Removes any remaining product-specific barrier
Retailer substitution	Shifts demand toward lower-cost suppliers

The main competitive advantage is usually distribution, retailer contracts, manufacturing economics, and product quality consistency.

Which companies are challenging Mucus Relief Extended Release?

The competitive field is likely to include:

• National OTC brands selling guaifenesin ER
• Store-brand and private-label manufacturers
• Contract development and manufacturing organizations
• International suppliers seeking U.S. OTC market access
• Combination-product manufacturers selling guaifenesin with dextromethorphan, pseudoephedrine, or other actives

Direct company-level attribution depends on the exact labeler and NDC. Large OTC manufacturers and private-label suppliers compete through retailer relationships, broad product portfolios, and low-cost production. The most relevant commercial competitors may not use the same trade name.

What generic launch risks exist for Mucus Relief Extended Release?

The principal launch risks are operational rather than patent-driven.

Dissolution failure

An extended-release product must maintain its release profile across:

• Different tablet hardness levels
• Multiple dissolution apparatus conditions
• Accelerated and long-term stability
• Manufacturing-scale changes
• Packaging configurations
• Relevant pH environments

A product that passes initial release testing but shifts during stability can generate recalls, retailer delisting, or costly reformulation.

Dose dumping

Alcohol exposure and high-agitation conditions should be assessed where appropriate. The formulation must avoid an unintended rapid release that could increase safety or regulatory risk.

Tablet size and adherence

A technically successful 1,200 mg ER tablet may be too large for some consumers. Tablet dimensions can affect repeat purchase, complaints, and product ratings.

Supply-chain concentration

Dependence on a single HPMC, coating, or high-volume filler supplier creates continuity risk. Dual sourcing should be assessed early, because switching excipient grades can change dissolution and compression behavior.

What licensing deals are relevant to guaifenesin extended release?

Licensing value is likely to arise from technology rather than from guaifenesin rights. Potentially licensable assets include:

• Proprietary release-control polymers
• Co-processed excipients
• Multiparticulate coating systems
• Direct-compression platforms
• Small-tablet or swallowability technology
• Packaging systems that preserve dissolution
• Combination-product platforms

A license is commercially attractive only if the technology produces a quantifiable advantage over standard HPMC matrix manufacturing. A generic formulation with common excipients is more likely to be manufactured under supply or contract-development arrangements than under a high-value patent license.

What commercial opportunities exist for excipient suppliers?

The best opportunities are concentrated in four areas.

Opportunity	Buyer value	Development priority
High-performance HPMC system	Consistent 12-hour release	High
Smaller-tablet platform	Better swallowability and differentiation	High
Direct-compression excipient blend	Lower manufacturing cost	High
Moisture-resistant formulation and packaging	Fewer stability failures	Medium to high
Sprinkle or multiparticulate dosage form	New consumer segment	Medium
Premium flavor or sensory system	Improved consumer experience	Medium
Novel excipient with no clear performance gain	Limited	Low

An excipient company should position the offering around validated performance metrics: dissolution robustness, tablet size, press speed, tensile strength, stability, and cost per dose.

How does Mucus Relief Extended Release compare with immediate-release guaifenesin?

Factor	Extended-release guaifenesin	Immediate-release guaifenesin
Dosing frequency	Typically lower	Typically higher
Formulation complexity	Higher	Lower
Manufacturing cost	Higher	Lower
Excipient value	Stronger opportunity for release-control systems	More focused on compression and disintegration
Tablet size pressure	Greater	Lower per unit
Dissolution risk	Significant	Less complex
Consumer proposition	Convenience	Lower price and flexibility
Patent differentiation	More plausible for specific formulation	Generally limited

Extended release can command a commercial premium, but only if consumers value reduced dosing frequency and the product remains easy to swallow.

Key Takeaways

• Mucus Relief Extended Release is generally a guaifenesin OTC extended-release tablet category.
• The product’s main technical asset is the release-control system, not the active ingredient.
• HPMC matrix technology offers the strongest cost-to-complexity profile for most products.
• The most attractive excipient opportunities involve smaller tablets, robust dissolution, direct compression, and moisture control.
• Guaifenesin has little active-ingredient exclusivity value.
• Orange Book and Paragraph IV strategies are generally less relevant to an OTC monograph product.
• Formulation, process, packaging, and manufacturing patents may still affect freedom to operate.
• Commercial success depends on retailer contracts, reliable supply, manufacturing cost, product quality, and consumer acceptance.
• The strongest licensing candidates are validated excipient platforms with measurable performance improvements.
• Exact patent, litigation, and NDC conclusions require product-specific identification because the trade name can cover different labelers and formulations.

FAQs

Is guaifenesin extended release protected by a patent?

The active ingredient is not expected to provide meaningful current exclusivity. A specific extended-release formulation may have patent protection, but protection would depend on the asserted claims, filing history, and expiration date.

Can a company launch a private-label Mucus Relief Extended Release product?

Yes, provided the product satisfies the applicable OTC regulatory requirements, manufacturing standards, labeling conditions, quality specifications, and any enforceable third-party patent or contract restrictions.

Which excipient is most important in a guaifenesin ER tablet?

HPMC is often the central release-controlling excipient in a hydrophilic matrix design. Its grade, viscosity, loading, particle size, and interaction with compression conditions can materially affect dissolution.

Is a guaifenesin ER formulation eligible for a premium price?

Potentially. The strongest premium case is based on a smaller tablet, easier swallowing, more reliable 12-hour release, improved packaging, or a differentiated administration format. A conventional large HPMC tablet is more exposed to private-label price competition.

Are biosimilars relevant to Mucus Relief Extended Release?

No. Guaifenesin is a small-molecule OTC active ingredient, not a biologic. Biosimilar pathways do not apply.

References

1. U.S. Food and Drug Administration. (n.d.). 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. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-341

2. U.S. Food and Drug Administration. (2015). Abbreviated new drug application submissions: Refuse-to-receive standards. FDA.

3. U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

4. U.S. Food and Drug Administration. (2024). Current good manufacturing practice for finished pharmaceuticals, 21 C.F.R. Parts 210 and 211. Electronic Code of Federal Regulations. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-210

5. U.S. Pharmacopeial Convention. (2024). United States Pharmacopeia and National Formulary. United States Pharmacopeial Convention.