List of Excipients in Branded Drug GUAIFENESIN 600 MG

« Back to Dashboard

Generic Drugs Containing GUAIFENESIN 600 MG

Company	Ingredient	NDC	Excipient
MARKSANS PHARMA LIMITED	guaifenesin 600 mg	25000-042	COPOVIDONE K25-31
MARKSANS PHARMA LIMITED	guaifenesin 600 mg	25000-042	FD&C BLUE NO. 1 ALUMINUM LAKE
MARKSANS PHARMA LIMITED	guaifenesin 600 mg	25000-042	HYPROMELLOSE
MARKSANS PHARMA LIMITED	guaifenesin 600 mg	25000-042	MAGNESIUM STEARATE
MARKSANS PHARMA LIMITED	guaifenesin 600 mg	25000-042	MALTODEXTRIN
MARKSANS PHARMA LIMITED	guaifenesin 600 mg	25000-042	MICROCRYSTALLINE CELLULOSE 102

What are the Most Frequently-Used Excipients in GUAIFENESIN 600 MG?

# Of NDCs	Excipient
4	CARBOMER HOMOPOLYMER TYPE B
4	CELLULOSE, MICROCRYSTALLINE
1	COPOVIDONE K25-31
1	FD&C BLUE NO. 1 ALUMINUM LAKE
4	FERRIC OXIDE RED
4	HYDROXYPROPYL CELLULOSE

Guaifenesin 600 mg Excipient Strategy, Formulation Economics, and Commercial Opportunities

Last updated: October 3, 2026

Guaifenesin 600 mg is primarily an extended-release oral solid-dose opportunity. The active ingredient is inexpensive, widely available, and not differentiated by new chemical entity exclusivity. Commercial value comes from controlled drug release, tablet robustness, swallowability, packaging, combination products, retailer economics, and regulatory execution.

The strongest formulation strategy is a hydrophilic matrix tablet using hypromellose or a comparable release-controlling polymer, supported by direct compression or a low-moisture granulation process. Manufacturers can compete through private-label products, retailer brands, combination cold-and-cough products, and geographic markets where branded guaifenesin penetration remains limited.

What is guaifenesin 600 mg used for?

Guaifenesin is an expectorant used to loosen phlegm and thin bronchial secretions associated with respiratory congestion. The 600 mg strength is commonly delivered as a 12-hour extended-release tablet.

Attribute	Guaifenesin 600 mg
Active ingredient	Guaifenesin
Therapeutic category	Expectorant
Common dosage form	Extended-release tablet
Typical adult and adolescent use	600 mg every 12 hours, subject to product labeling
Regulatory category	OTC drug in the United States
Primary commercial reference	Mucinex 600 mg extended-release products
Prescription requirement	No, for compliant OTC products
Primary formulation challenge	Sustained release with acceptable tablet size and dissolution
Main competitive alternatives	Generic guaifenesin ER, immediate-release guaifenesin, combination cough-and-cold products
Principal commercial risks	Low unit price, retailer private-label pressure, formulation similarity, seasonal demand

The FDA OTC monograph framework identifies guaifenesin as an oral expectorant active ingredient. The applicable conditions include dosage, labeling, and claims requirements for OTC cough and cold products.[1]

What excipients are used in guaifenesin 600 mg extended-release tablets?

The central excipient system normally includes a release-controlling polymer, compression aid, lubricant, glidant, coating system, and moisture-control components. Exact excipient selections vary by manufacturer and cannot be inferred solely from the 600 mg strength.

Recommended excipient architecture

Formulation function	Candidate excipients	Commercial purpose
Release control	Hypromellose, hydroxypropyl cellulose, ethylcellulose	Controls water penetration and drug diffusion
Dilution and compression	Microcrystalline cellulose, dibasic calcium phosphate, pregelatinized starch	Improves tablet hardness, flow, and manufacturability
Granulation or binding	Povidone, copovidone, pregelatinized starch	Improves granule strength and content uniformity
Disintegration adjustment	Crospovidone, croscarmellose sodium, sodium starch glycolate	Controls breakup of non-matrix portions
Lubrication	Magnesium stearate, sodium stearyl fumarate	Reduces ejection force and tooling adhesion
Flow enhancement	Colloidal silicon dioxide	Improves powder flow and blend uniformity
Film coating	Hypromellose, polyethylene glycol, titanium dioxide or permitted colorants	Improves appearance, handling, identification, and moisture protection
Taste and mouthfeel control	Film coating, high-solids surface layer, polymer barrier	Reduces bitterness and chalky perception if the tablet is chewed or damaged
Moisture protection	High-barrier bottle, desiccant, moisture-resistant coating	Protects dissolution performance and tablet integrity

Hypromellose is the most commercially practical starting point for a 600 mg extended-release matrix. Polymer grade, viscosity, particle size, substitution pattern, concentration, and manufacturing shear can materially affect release. A formulation using a high-viscosity grade may provide stronger release control but can increase tablet size, processing difficulty, and risk of incomplete drug release.

The formulation should be designed around the complete matrix rather than around a single excipient. Guaifenesin loading, particle-size distribution, polymer hydration, compression force, tablet porosity, and coating permeability jointly determine dissolution.

How should a guaifenesin 600 mg extended-release tablet be formulated?

A practical development target is a robust hydrophilic matrix tablet with sufficient polymer to maintain 12-hour performance across physiological pH conditions.

Direct compression strategy

Direct compression can reduce processing steps and manufacturing cost. It is attractive where the guaifenesin active pharmaceutical ingredient has suitable flow and compressibility.

The main development controls are:

• Active particle-size distribution
• Blend uniformity at high drug loading
• Polymer segregation
• Lubricant mixing time
• Tablet tensile strength
• Compression force
• Ejection behavior
• Weight variation
• Dissolution profile

Direct compression can create segregation risk when the active ingredient and polymer have materially different particle sizes or densities. A pre-blend, ordered mixing process, or co-processed excipient system can reduce that risk.

Wet granulation strategy

Wet granulation can improve flow, reduce segregation, and increase tablet strength. It also introduces a moisture and drying burden. Guaifenesin products should be evaluated for moisture-related changes in polymorphic form, particle agglomeration, tablet hardness, coating adhesion, and dissolution.

A low-moisture or solvent-restricted process may be commercially preferable where the active or polymer system is sensitive to water. Fluid-bed granulation can provide strong process control but may increase capital requirements and cycle time.

Matrix-polymer optimization

The key variables are polymer concentration and viscosity. Higher polymer loading generally slows release, but it can also increase tablet mass and swelling. A low-viscosity polymer may improve manufacturability but provide weaker release control.

A development program should compare:

1. One high-viscosity hypromellose grade.
2. A combination of low- and high-viscosity grades.
3. Hypromellose with a secondary hydrophobic or water-insoluble barrier.
4. A coated multiparticulate or granule-based system.

The fourth option can provide differentiated release behavior but usually has a higher cost of goods and more complex scale-up.

What dissolution and quality attributes matter for guaifenesin 600 mg?

Extended-release guaifenesin products require a dissolution profile that supports the labeled dosing interval without rapid dose dumping. The development package should establish release behavior under multiple pH conditions, agitation rates, and media volumes.

Key quality attributes include:

• Assay and content uniformity
• Tablet weight and thickness
• Hardness and friability
• Dissolution at multiple time points
• Related substances and degradation products
• Moisture content
• Microbial quality
• Coating uniformity
• Extractables and leachables from packaging
• Stability under long-term and accelerated conditions

The product should be tested after mechanical stress, including friability, shipping simulation, bottle vibration, and tablet-to-tablet abrasion. A 600 mg tablet can be large and susceptible to breakage, edge chipping, and coating damage.

The most commercially useful dissolution profile is one that is distinct from immediate release but does not depend on an overly narrow process window. A formulation that meets specification only at a limited compression force or polymer moisture level is less suitable for multi-site production.

What FDA regulatory pathway applies to guaifenesin 600 mg?

A guaifenesin 600 mg product may be developed under the FDA OTC monograph framework if it meets the applicable active-ingredient, dosage, labeling, and manufacturing requirements. The product must also comply with current good manufacturing practice requirements and applicable drug listing obligations.[1][2]

OTC monograph route

The OTC route offers several commercial advantages:

• No conventional new drug application is required when the product conforms to the applicable monograph conditions.
• There is no new chemical entity exclusivity for guaifenesin.
• The product can be positioned as a store brand, contract-manufactured product, or branded OTC product.
• Regulatory cost is generally lower than for a new prescription product.

The main constraints are narrow labeling flexibility and limited ability to make claims outside the monograph. A formulation change that materially alters dosing, release, labeling, or claims can create a different regulatory analysis.

NDA or monograph-order considerations

An NDA-based extended-release product may create a different Orange Book and reference-product analysis from a purely monograph-compliant product. The sponsor must determine whether the intended product is marketed under the monograph, relies on an approved NDA, or requires an application because of formulation, labeling, or claim differences.

What patents protect guaifenesin 600 mg products?

The guaifenesin molecule is an old active ingredient and does not provide modern new chemical entity exclusivity. The commercial protection for a 600 mg product usually comes from formulation claims, manufacturing claims, trademarks, packaging, and brand recognition rather than active-ingredient patents.

Potentially relevant patent categories include:

• Extended-release matrix compositions
• Polymer combinations
• Coated guaifenesin particles
• Multiparticulate dosage forms
• Abuse-deterrent or tamper-resistant designs
• Combination products containing guaifenesin
• Manufacturing processes
• Taste-masking systems
• Packaging and dispensing systems

A formulation patent must be assessed claim by claim. A generic manufacturer may avoid infringement through different polymer ratios, different coating systems, alternative processing conditions, or a distinct release mechanism.

Orange Book status and Paragraph IV risk

Orange Book exposure depends on the regulatory status of the specific reference product. A monograph-only product does not create the same Orange Book pathway as an NDA reference product. If an NDA-listed product has relevant patents, an ANDA sponsor may face patent certification requirements, including a Paragraph IV certification.

For guaifenesin 600 mg, the principal competitive risk is generally not active-ingredient patent expiry. It is the possibility of formulation patents, regulatory exclusivities, trademark restrictions, or litigation involving a branded extended-release product.

The commercial review should cover:

Issue	Relevance to guaifenesin 600 mg
Active-ingredient patent	Usually not a barrier because guaifenesin is an established generic active
NCE exclusivity	Not applicable to this old active ingredient
Formulation patent	Potentially relevant for extended-release technologies
Method-of-use patent	Usually limited because expectorant use is established
Orange Book listing	Depends on the reference product’s approval basis
Paragraph IV challenge	Relevant only where an ANDA references an NDA with listed patents
Trademark	Important for brand names, trade dress, and retailer positioning
Manufacturing patent	May affect specific coated or multiparticulate technologies

No commercial launch should rely on a conclusion that the active ingredient is unpatented. The relevant analysis is the full product, formulation, regulatory pathway, and jurisdiction.

What commercial opportunities exist for guaifenesin 600 mg?

The strongest opportunities are in channels where formulation cost, retailer access, and seasonal availability determine market share.

Private-label and retailer brands

Retailers can offer 600 mg extended-release guaifenesin under store brands with lower marketing costs than national brands. The opportunity is strongest where the manufacturer can provide:

• Stable supply before the respiratory season
• Multiple bottle counts
• Competitive unit economics
• Compliant OTC labeling
• Reliable dissolution equivalence or performance
• Short lead times for seasonal replenishment

Packaging formats can include 20-, 30-, 40-, 60-, and 100-count bottles. Larger count sizes improve household value perception and reduce packaging cost per tablet.

Combination respiratory products

Guaifenesin 600 mg can be combined commercially with active ingredients such as dextromethorphan, pseudoephedrine, or acetaminophen, subject to applicable FDA requirements and labeling restrictions.

Combination products increase shelf visibility and average retail value, but they also increase development complexity. Risks include:

• Separate release rates for each active
• Drug-drug compatibility
• Larger tablets
• Greater label complexity
• Duplicate therapy and misuse concerns
• State and federal restrictions affecting pseudoephedrine
• More extensive stability and dissolution requirements

A dual-layer tablet or physically segregated granule system may be needed when the second active has a different release target.

Pediatric and swallowability products

A 600 mg tablet is generally not a pediatric universal dosage form. The better opportunity for younger populations is a separate lower-strength or liquid formulation, not a simple relabeling of the adult tablet.

For adults, commercial differentiation can include:

• Smaller tablets at the same dose
• Film-coated tablets with improved swallowability
• Tablets with clear dose markings
• Unit-dose blister packaging
• Lower-sugar liquid alternatives for adjacent age groups

A smaller tablet may require higher drug loading, denser compression, or a more efficient release polymer system. Those changes can create a meaningful formulation barrier even when the active ingredient is generic.

How does guaifenesin 600 mg compare with immediate-release guaifenesin?

Criterion	600 mg extended release	Immediate release
Dosing frequency	Typically twice daily	More frequent dosing
Tablet size	Larger	Smaller
Formulation complexity	Higher	Lower
Polymer dependence	High	Low
Manufacturing cost	Higher	Lower
Convenience	Stronger	Weaker
Patent differentiation	More possible	Limited
Generic competition	Strong	Very strong
Commercial positioning	Premium convenience	Value and flexibility

The extended-release format supports a higher retail price and stronger brand positioning. Immediate-release products remain attractive where consumers prioritize low price or flexible dosing.

Which companies are competing in guaifenesin 600 mg?

The market includes national OTC brands, private-label retailers, contract manufacturers, and generic drug companies. Reckitt’s Mucinex franchise is the best-known branded commercial reference for extended-release guaifenesin in the United States. Store brands and generic suppliers compete primarily through price, retail distribution, and supply reliability.

The competitive landscape is fragmented at the manufacturing level. A sponsor does not need a unique active ingredient to compete, but it does need a validated extended-release platform, compliant labeling, stable supply, and channel access.

What manufacturing and intellectual-property barriers exist?

The active ingredient is not the main barrier. The practical barriers are formulation reproducibility and commercial execution.

The most important manufacturing risks are:

• High-dose blend segregation
• Inconsistent polymer distribution
• Tablet capping and lamination
• Excessive tablet size
• Slow or variable dissolution
• Coating defects
• Moisture-driven stability changes
• Packaging failures during seasonal distribution
• Inadequate scale-up from laboratory compression to commercial equipment

The most important intellectual-property risks are formulation patents, combination-product claims, proprietary coating systems, and trademark or trade-dress restrictions. A legally available guaifenesin supply does not establish freedom to commercialize a particular 600 mg extended-release product.

What is the revenue opportunity for guaifenesin 600 mg?

Exact brand revenue is not separately reported by most manufacturers. Revenue exposure is seasonal and concentrated in the fall and winter respiratory period, with additional demand during regional outbreaks and cold-season peaks.

A commercial model should measure:

• Net revenue per tablet
• Retailer margin
• Manufacturing cost per tablet
• Packaging cost
• Slotting and promotional allowances
• Seasonal inventory carrying cost
• Return and expiration risk
• Contract manufacturing minimums
• Cost of regulatory maintenance
• Litigation and formulation-design-around reserves

The most defensible margin strategy is usually a two-tier portfolio: a low-cost standard extended-release tablet for private-label volume and a differentiated product using improved swallowability, packaging, or a combination indication.

Key Takeaways

• Guaifenesin 600 mg is an established OTC extended-release opportunity, not a new chemical entity opportunity.
• Hypromellose-based matrix technology is the most practical formulation starting point.
• Direct compression offers lower cost, while wet granulation can improve flow and content uniformity.
• Dissolution robustness, tablet size, moisture control, and mechanical durability determine commercial viability.
• Private-label and retailer-brand products are the clearest near-term opportunities.
• Combination products can increase value but introduce more complex regulatory and formulation requirements.
• Active-ingredient patent risk is limited, while formulation patents, trademarks, and NDA-specific Orange Book issues require product-level review.
• The commercial advantage lies in release control, supply reliability, packaging, and channel execution.

FAQs about guaifenesin 600 mg formulation and commercialization

Is hypromellose the best excipient for guaifenesin 600 mg extended release?

Hypromellose is the most practical first-line matrix polymer because it is widely available, scalable, and accepted in oral solid-dose products. The optimal grade and concentration must be established through dissolution and stability testing.

Can guaifenesin 600 mg be made as a smaller tablet?

Yes. A smaller tablet may require higher drug loading, denser compression, a different polymer system, or a multiparticulate design. Tablet size reduction can improve swallowability but may narrow the manufacturing process window.

Does guaifenesin 600 mg require an ANDA?

Not necessarily. A product that complies with the applicable FDA OTC monograph may use the monograph pathway. An NDA or ANDA analysis becomes relevant when the product relies on an approved NDA reference, falls outside monograph conditions, or uses a distinct regulatory basis.

Are guaifenesin 600 mg formulation patents commercially important?

They can be. The principal patent risk is usually tied to the extended-release matrix, coating, multiparticulate system, combination product, or manufacturing process rather than to guaifenesin itself.

What is the strongest differentiation strategy for a new guaifenesin 600 mg product?

The strongest strategies are a smaller swallowable tablet, robust 12-hour dissolution, improved moisture protection, low-cost private-label manufacturing, unit-dose packaging, or a compliant combination product with a clear consumer benefit.

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.
2. U.S. Food and Drug Administration. (2024). Over-the-counter monograph M012: Cough and cold products.
3. U.S. Food and Drug Administration. (2024). Inactive ingredient database.
4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
5. International Council for Harmonisation. (2009). ICH Q8(R2): Pharmaceutical development.
6. International Council for Harmonisation. (2005). ICH Q9: Quality risk management.
7. International Council for Harmonisation. (2008). ICH Q10: Pharmaceutical quality system.
8. DailyMed. (2024). Guaifenesin extended-release tablet labeling. National Library of Medicine.