List of Excipients in Branded Drug GOOD SENSE MUCUS ER

Generic Drugs Containing GOOD SENSE MUCUS ER

Company	Ingredient	NDC	Excipient
L Perrigo Company	guaifenesin	0113-0325	CELLULOSE, MICROCRYSTALLINE
L Perrigo Company	guaifenesin	0113-0325	COPOVIDONE K25-31
L Perrigo Company	guaifenesin	0113-0325	FD&C BLUE NO. 1
L Perrigo Company	guaifenesin	0113-0325	HYPROMELLOSE
L Perrigo Company	guaifenesin	0113-0325	MAGNESIUM STEARATE
L Perrigo Company	guaifenesin	0113-0325	MALTODEXTRIN

What are the Most Frequently-Used Excipients in GOOD SENSE MUCUS ER?

# Of NDCs	Excipient
4	CARBOMER HOMOPOLYMER TYPE B
5	CELLULOSE, MICROCRYSTALLINE
2	COPOVIDONE K25-31
1	FD&C BLUE NO. 1
3	FD&C BLUE NO. 1 ALUMINUM LAKE
5	HYPROMELLOSE

Good Sense Mucus ER Excipient Strategy and Commercial Opportunities

Last updated: August 22, 2026

Good Sense Mucus ER is an over-the-counter extended-release guaifenesin product positioned for 12-hour mucus relief. Its commercial value comes from low-cost active pharmaceutical ingredient, mature excipient technology, broad OTC eligibility, and private-label scalability rather than from patent exclusivity. The strongest opportunities are supply-chain optimization, tablet robustness, swallowability, packaging, retailer-specific branding, and line extensions.

What is Good Sense Mucus ER?

Good Sense Mucus ER contains guaifenesin in an extended-release oral tablet. Guaifenesin is an expectorant used to loosen phlegm and thin bronchial secretions. The product is generally marketed in 600 mg and/or 1,200 mg extended-release strengths depending on the specific stock-keeping unit and market channel.

Attribute	Product profile
Brand	Good Sense
Product type	OTC extended-release oral tablet
Active ingredient	Guaifenesin
Therapeutic category	Expectorant
Administration	Oral
Release profile	Extended release, typically 12 hours
Primary consumer claim	Mucus relief and loosening of phlegm
Regulatory route	FDA OTC monograph pathway
Prescription status	Nonprescription
Biosimilar relevance	None
Orange Book relevance	Generally limited because the product is an OTC monograph drug rather than an NDA-listed prescription product

The exact strength, tablet design, manufacturer, and inactive-ingredient list can vary by National Drug Code and private-label contract manufacturer. Commercial diligence should therefore be performed at the NDC and labeler level rather than solely at the Good Sense brand level.

What excipients are used in Good Sense Mucus ER?

The extended-release tablet platform typically relies on a hydrophilic matrix and standard oral-solid-dose processing excipients. Public product labeling for guaifenesin extended-release tablets commonly identifies excipients such as hypromellose, microcrystalline cellulose, crospovidone, sodium starch glycolate, povidone, magnesium stearate, colloidal silicon dioxide, talc, polyethylene glycol, and titanium dioxide. The precise Good Sense composition should be confirmed against the current package insert or DailyMed entry for the relevant NDC.[1]

Likely functional roles of the excipients

Excipient class	Typical materials	Primary function in the formulation
Matrix former	Hypromellose	Controls water penetration, swelling, gel formation, and guaifenesin diffusion
Diluent	Microcrystalline cellulose	Adds tablet mass, improves compressibility, and supports content uniformity
Binder	Povidone	Improves granule and tablet strength
Disintegrant	Crospovidone or sodium starch glycolate	Promotes breakup of non-matrix portions of the tablet
Glidant	Colloidal silicon dioxide	Improves powder flow and die filling
Lubricant	Magnesium stearate	Reduces punch and die adhesion
Processing aid or coating component	Talc	Supports flow, anti-sticking, or coating performance
Film-coating component	Polyethylene glycol and titanium dioxide	Supports coating flexibility, appearance, and opacity

The critical excipient is the release-controlling polymer. In an extended-release guaifenesin tablet, hypromellose grade, viscosity, particle size, concentration, and hydration behavior can materially affect the dissolution profile. Changes that appear minor from a formulation perspective can alter release over the full dosing interval.

How does the extended-release excipient system work?

A hydrophilic matrix tablet generally controls release through polymer hydration and gel-layer formation. After ingestion, gastrointestinal fluid penetrates the tablet. Hypromellose hydrates and forms a viscous barrier. Guaifenesin then moves through the hydrated polymer by diffusion, while erosion of the matrix can contribute to later-stage release.

The formulation must balance four competing requirements:

1. Sufficient mechanical strength for manufacturing, transport, and handling.
2. Controlled release over the labeled dosing interval.
3. Acceptable tablet size and swallowability.
4. Rapid enough release to support the onset-of-action expectation for an OTC product.

A high-polymer formulation may extend release but produce a large, hard-to-swallow tablet. A low-polymer formulation may improve onset but fail the dissolution target. Excessive compression force can reduce porosity and slow hydration. Excessive lubricant can weaken tablet bonding or delay wetting.

Key critical quality attributes

For Good Sense Mucus ER or a comparable private-label product, the principal critical quality attributes are:

• Assay and content uniformity of guaifenesin.
• Tablet weight and hardness.
• Friability.
• Thickness and coating uniformity.
• Dissolution at multiple time points.
• Water activity and moisture content.
• Stability under temperature and humidity stress.
• Extractables and leachables from packaging.
• Ease of swallowing and resistance to chipping.
• Physical compatibility with the intended bottle or blister package.

The dissolution profile is the most commercially sensitive quality attribute because it connects the excipient system to the extended-release claim.

What formulation patents protect guaifenesin extended-release products?

Guaifenesin is an old active ingredient with no meaningful composition-of-matter exclusivity for current OTC products. Commercial protection is more likely to arise from formulation know-how, manufacturing controls, trademarks, packaging, and retailer relationships than from enforceable active-ingredient patents.

Potentially protectable subject matter includes:

• Specific polymer ratios or polymer combinations.
• Multiparticulate or coated-particle release systems.
• Abuse-resistant or tamper-evident delivery systems.
• Low-size, high-dose tablet designs.
• Taste-masking systems for liquid or orally disintegrating products.
• Bilayer or dual-release tablets.
• Manufacturing processes that improve dissolution consistency.
• Moisture-resistant coatings and packaging systems.

A generic or private-label manufacturer could use a different excipient system and avoid a narrow formulation patent if the resulting product meets FDA requirements and does not infringe the relevant claims. For an OTC monograph product, regulatory compliance does not eliminate patent risk, but the absence of a new-drug exclusivity framework reduces the value of conventional Orange Book patent barriers.

When does Good Sense Mucus ER lose exclusivity?

Good Sense Mucus ER does not depend on a conventional prescription-drug exclusivity period. Guaifenesin is available under the FDA OTC monograph framework for eligible expectorant products. The commercial product therefore faces competition from Mucinex, store brands, mass retailers, pharmacies, online sellers, and other guaifenesin products.

Exclusivity category	Relevance to Good Sense Mucus ER
New chemical entity exclusivity	None expected
Five-year NDA exclusivity	Not the primary regulatory structure
Three-year clinical-investigation exclusivity	Not expected
Pediatric exclusivity	Not expected
Orphan exclusivity	None
Biologic exclusivity	None
OTC monograph status	Central regulatory pathway
Trademark protection	May protect Good Sense branding
Formulation patent protection	Possible but product-specific
Trade-secret protection	Important for process parameters and supplier specifications

The product can therefore be challenged commercially at any time by a compliant competing product, subject to manufacturing, labeling, quality, and distribution requirements.

What is the FDA regulatory status of Good Sense Mucus ER?

Guaifenesin expectorant products are regulated under FDA’s OTC monograph framework, including the final monograph requirements for internal analgesic, antipyretic, and antirheumatic drug products where applicable to the relevant product category and the specific OTC expectorant provisions.[2] The manufacturer must use an allowed active ingredient, conform to the applicable dosage and labeling conditions, and manufacture the product under current good manufacturing practice requirements.

FDA regulatory priorities include:

• Accurate active-ingredient declaration.
• Conformance with OTC Drug Facts labeling.
• Appropriate dosing instructions.
• Warnings for persistent or worsening symptoms.
• Quality-system compliance.
• Stability and expiration-date support.
• Control of dissolution for the extended-release dosage form.

The product is generally not dependent on an FDA-approved NDA in the same way as a prescription extended-release product. That distinction reduces regulatory entry barriers but increases price competition.

Does Good Sense Mucus ER have Orange Book patents?

Good Sense Mucus ER is not generally expected to have a conventional Orange Book patent estate comparable to an NDA-backed prescription medicine. The Orange Book primarily lists approved prescription and certain other drug products with patent and exclusivity information. OTC monograph products typically compete without the Paragraph IV certification process associated with ANDA applicants.

A competitor therefore would not ordinarily need to challenge a Good Sense Mucus ER Orange Book patent before launching a compliant OTC guaifenesin product. Patent risk could still arise from third-party formulation, coating, manufacturing, packaging, or delivery-system patents.

Are there Paragraph IV challenges to Good Sense Mucus ER?

A conventional Paragraph IV challenge is unlikely to be the principal competitive mechanism for Good Sense Mucus ER because the product is generally marketed under the OTC monograph pathway rather than through an NDA with listed Orange Book patents.

Competition is more likely to occur through:

• Another OTC monograph-compliant guaifenesin product.
• Retailer private-label substitution.
• Authorized store-brand manufacturing.
• Product reformulation.
• Lower-cost foreign or domestic API sourcing.
• Alternative dosage forms.
• Combination products containing guaifenesin and other OTC ingredients.

This structure makes manufacturing economics and retail placement more important than Hatch-Waxman litigation.

What excipient strategies create commercial opportunities?

1. Reduce tablet size

Guaifenesin requires a relatively high dose, particularly at 1,200 mg. Tablet size is a direct consumer barrier. A formulation that maintains extended release with less total excipient mass could improve swallowing and reduce complaints.

Potential approaches include:

• Higher-density microcrystalline cellulose.
• More efficient hypromellose grades.
• Direct-compression blends.
• Granulation processes that improve packing.
• Multiparticulate compression.
• Bilayer designs that separate loading and maintenance-release functions.

The opportunity is strongest for adult consumers who avoid large tablets and for retailers seeking differentiated products without a new active ingredient.

2. Improve dissolution robustness

Manufacturing variability in polymer hydration, granule porosity, compression force, and lubricant distribution can shift dissolution. A more robust formulation can reduce batch failures and release testing variability.

Commercially useful levers include:

• Tight control of hypromellose viscosity grade.
• Defined polymer particle-size distribution.
• Controlled granulation endpoint.
• Lower sensitivity to compression force.
• Reduced magnesium stearate over-lubrication.
• In-process near-infrared monitoring.
• Design-space development around dissolution rather than only assay.

This strategy can lower cost of goods by reducing rejected batches, investigations, and production downtime.

3. Improve swallowability and mouthfeel

Extended-release tablets are difficult to make small because guaifenesin is present at a high dose. Film coating can improve surface smoothness and reduce chalkiness. A low-friction coating may support easier swallowing without materially affecting release.

Potential excipient and dosage-form opportunities include:

• Smooth hypromellose-based film coating.
• Reduced tablet edge sharpness.
• Smaller multiparticulate capsules.
• Oral granules for consumers who cannot swallow tablets.
• Sugar-free liquid formulations.
• Orally disintegrating or chewable products, if the release profile and labeling requirements can be supported.

Chewable and orally disintegrating products require special attention because extended-release behavior can be disrupted by mastication or rapid dispersion.

4. Develop moisture-resistant packaging

Hydrophilic polymers can be sensitive to moisture exposure. A bottle, desiccant, induction seal, or high-barrier blister may preserve hardness, coating integrity, and dissolution performance.

Packaging upgrades can support:

• Longer shelf life.
• Distribution in humid climates.
• Reduced tablet sticking.
• Better stability after opening.
• Premium positioning.
• Lower consumer complaints.

Packaging may provide a more practical commercial advantage than a narrow formulation change because it can be implemented without materially changing the active formulation.

5. Optimize supply-chain economics

The largest cost opportunities may come from excipient and process optimization rather than from ingredient substitution alone.

Key levers are:

• Dual sourcing for hypromellose and microcrystalline cellulose.
• Qualification of regional excipient suppliers.
• Use of multifunctional excipients.
• Direct compression instead of wet granulation where feasible.
• Fewer coating passes.
• Lower tablet rejection rates.
• Standardized tablet tooling across multiple private-label customers.
• Harmonized excipient specifications across 600 mg and 1,200 mg strengths.

Excipient changes must be evaluated for dissolution equivalence, stability, processability, and labeling impact.

Which companies compete with Good Sense Mucus ER?

The primary competitive set includes:

Competitor	Product type	Commercial relevance
Mucinex	Branded extended-release guaifenesin	Category leader and reference brand
Walgreens, CVS, Walmart, and other store brands	Private-label guaifenesin products	Direct price competition
Rite Aid and regional pharmacy brands	Store-brand expectorants	Channel-specific substitution
Robitussin	Cough and cold products, including combination products	Brand recognition and broader symptom coverage
Generic manufacturers	Guaifenesin tablets, liquids, and extended-release forms	Manufacturing and wholesale competition
Combination-product manufacturers	Guaifenesin with dextromethorphan or other actives	Broader cough-and-cold positioning

Mucinex has stronger consumer recognition and advertising resources. Good Sense competes primarily through value pricing and retail availability. Private-label manufacturers can capture share by matching the dose, release duration, tablet appearance, and package count while reducing brand-related marketing costs.

How strong is the patent estate for Good Sense Mucus ER?

The patent estate is likely weak at the active-ingredient level and moderate only where product-specific formulation or process claims exist. The commercial moat is better described as operational than patent-based.

Protection layer	Relative strength
Guaifenesin active ingredient	Very low
OTC regulatory pathway	Low entry barrier
Extended-release formulation know-how	Moderate
Specific formulation patent claims	Product-dependent
Manufacturing process control	Moderate trade-secret value
Brand trademark	Moderate
Retail distribution	Moderate to strong within specific channels
Consumer recognition	Stronger for Mucinex than Good Sense
Packaging and merchandising	Moderate

A due-diligence review should search USPTO records, FDA labeling, assignment data, and relevant court dockets for the manufacturer or labeler associated with the exact NDC. Searching only the Good Sense trademark may miss patents held by a contract manufacturer or parent company.

What licensing and contract-manufacturing opportunities exist?

The product category is suitable for private-label licensing and contract manufacturing. A manufacturer can offer a standardized guaifenesin extended-release platform to multiple retailers, with changes limited to:

• Tablet imprint.
• Film-coat color.
• Bottle count.
• Carton and label.
• Retailer trademark.
• Package configuration.
• Approved inactive-ingredient presentation.

A platform approach can reduce development time and support rapid launches across pharmacy, grocery, club, dollar, and e-commerce channels. The main contractual issues are ownership of formulation improvements, responsibility for FDA compliance, change-control rights, excipient substitutions, stability data, recall allocation, and minimum purchase commitments.

Licensing value is higher for a formulation that delivers measurable advantages, such as smaller tablet size, improved humidity stability, lower manufacturing cost, or a differentiated dosage form. A basic guaifenesin extended-release tablet has limited royalty potential because numerous substitutes are available.

What generic launch risks exist?

Generic and private-label launch risk is high because:

• Guaifenesin is widely available.
• The active ingredient is inexpensive.
• OTC monograph compliance can reduce development barriers.
• Consumers can substitute among brands.
• Retailers have strong incentives to stock lower-cost alternatives.
• The product does not require clinical differentiation for routine expectorant claims.

The main launch constraints are product-quality execution, supply reliability, FDA compliance, retail authorization, and seasonal demand planning. A manufacturer that misses the cough-and-cold season may lose a large portion of its annual sales opportunity.

What geographic opportunities exist?

The most attractive markets are jurisdictions where guaifenesin is recognized as an OTC expectorant and where extended-release tablets are accepted by consumers. Opportunities include:

• United States private-label retail.
• Canada and other North American markets.
• Latin American markets with pharmacy-led OTC distribution.
• Selected Asia-Pacific markets with growing self-care demand.
• E-commerce channels serving expatriate and cross-border consumers.

Regulatory classification, permitted claims, excipient restrictions, language requirements, and dosage-form conventions differ by country. A U.S. OTC monograph-compliant formulation cannot automatically be commercialized worldwide without local regulatory review.

Key Takeaways

• Good Sense Mucus ER is an OTC extended-release guaifenesin product with low active-ingredient barriers to entry.
• Hypromellose is the central release-controlling excipient in the likely matrix-tablet platform.
• Microcrystalline cellulose, povidone, crospovidone, sodium starch glycolate, magnesium stearate, colloidal silicon dioxide, talc, polyethylene glycol, and titanium dioxide support processing, strength, coating, and performance.
• The product is generally not protected by an NDA-style Orange Book exclusivity strategy.
• Paragraph IV litigation is unlikely to be the main competitive issue.
• The best commercial opportunities are smaller tablets, better swallowability, improved dissolution robustness, moisture-resistant packaging, and private-label platform manufacturing.
• Patent strength is likely limited for guaifenesin itself and depends on any product-specific formulation or process claims.
• Retail distribution, manufacturing reliability, seasonal inventory planning, and cost control are more important than conventional patent exclusivity.

FAQs About Good Sense Mucus ER Excipient and Commercial Strategy

Can hypromellose be replaced in Good Sense Mucus ER?

Yes, but replacement requires development and comparative dissolution work. Alternative matrix formers may change hydration, swelling, erosion, and release kinetics. A substitution can also affect tablet hardness, coating adhesion, and stability.

Is guaifenesin extended-release technology difficult to manufacture?

It is technically manageable but sensitive to polymer grade, compression force, granulation, lubrication, and moisture. The main challenge is maintaining dissolution consistency at commercial scale.

Can Good Sense Mucus ER be reformulated as a capsule?

Yes. A capsule could contain coated guaifenesin particles or multiparticulates. The formulation would need to preserve the extended-release profile and meet applicable OTC labeling and quality requirements.

Is a 1,200 mg guaifenesin tablet commercially attractive?

Yes. It offers twice-daily convenience and can reduce dosing frequency. The principal drawback is tablet size, which creates an opportunity for high-density formulations, coated multiparticulates, or alternative dosage forms.

What is the highest-value improvement for a private-label guaifenesin product?

For a mass-market product, the highest-value improvement is usually a combination of low manufacturing cost, reliable dissolution, moisture stability, and acceptable swallowability. A narrow patent position alone is unlikely to support a durable premium.

References

1. U.S. National Library of Medicine. (n.d.). DailyMed: Guaifenesin extended-release tablet labeling. https://dailymed.nlm.nih.gov
2. U.S. Food and Drug Administration. (n.d.). Over-the-counter monograph drugs and expectorant drug products. https://www.fda.gov
3. U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov
4. U.S. Food and Drug Administration. (2024). Current good manufacturing practice requirements for finished pharmaceuticals, 21 C.F.R. Parts 210 and 211. https://www.ecfr.gov
5. U.S. Pharmacopeia. (2024). United States Pharmacopeia and National Formulary. United States Pharmacopeial Convention.