List of Excipients in Branded Drug GOOD SENSE ALL DAY ALLERGY D

Generic Drugs Containing GOOD SENSE ALL DAY ALLERGY D

Company	Ingredient	NDC	Excipient
L Perrigo Company	cetirizine hydrochloride, pseudoephedrine hydrochloride	0113-0147	CELLULOSE, MICROCRYSTALLINE
L Perrigo Company	cetirizine hydrochloride, pseudoephedrine hydrochloride	0113-0147	HYPROMELLOSE
L Perrigo Company	cetirizine hydrochloride, pseudoephedrine hydrochloride	0113-0147	LACTOSE MONOHYDRATE
L Perrigo Company	cetirizine hydrochloride, pseudoephedrine hydrochloride	0113-0147	LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE

What are the Most Frequently-Used Excipients in GOOD SENSE ALL DAY ALLERGY D?

# Of NDCs	Excipient
2	CELLULOSE, MICROCRYSTALLINE
1	FERRIC OXIDE YELLOW
1	HYPROMELLOSE
1	HYPROMELLOSES

Good Sense All Day Allergy D: Excipient Strategy and Commercial Opportunities

Last updated: August 23, 2026

Good Sense All Day Allergy D is a private-label extended-release combination of cetirizine hydrochloride and pseudoephedrine hydrochloride. The standard product contains cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg per tablet and is marketed for 24-hour relief of allergy and nasal-congestion symptoms.[1] Its commercial opportunity is primarily excipient-led: improving tablet manufacturability, release control, swallowability, allergen positioning, packaging, and retailer differentiation rather than creating new active-ingredient exclusivity.

The most attractive development paths are:

1. A lower-cost robust extended-release platform.
2. A smaller or easier-to-swallow tablet.
3. A lactose-free, gluten-free, or reduced-irritant formulation.
4. A premium non-drowsy allergy and congestion product with improved patient experience.
5. Retailer-specific private-label versions using the same active combination but differentiated excipient and packaging profiles.

What is Good Sense All Day Allergy D?

Good Sense All Day Allergy D combines:

Attribute	Product profile
Brand	Good Sense
Product	All Day Allergy D
Active ingredients	Cetirizine HCl 5 mg; pseudoephedrine HCl 120 mg
Dosage form	Extended-release oral tablet
Therapeutic category	Antihistamine plus nasal decongestant
Primary use	Temporary relief of allergy symptoms and nasal congestion
Dosing profile	Generally one tablet every 24 hours
Regulatory category	OTC product marketed under an FDA-approved or authorized generic framework, depending on the specific NDC and labeler
Key commercial constraint	Pseudoephedrine sales, storage, and purchase restrictions

The product competes with Zyrtec-D 24 Hour and other store-brand cetirizine-pseudoephedrine extended-release tablets. Cetirizine provides H1-antihistamine activity, while pseudoephedrine produces systemic nasal decongestant effects. The extended-release design must deliver a reliable pseudoephedrine exposure over the labeled dosing interval without compromising tablet integrity or cetirizine release.

What excipients are used in Good Sense All Day Allergy D?

Public product labeling identifies conventional solid-dose excipients associated with immediate-release antihistamine delivery and extended-release tablet manufacture. The formulation commonly includes:

Excipient class	Typical function
Hypromellose	Hydrophilic matrix former and release-control polymer
Microcrystalline cellulose	Diluent and compression aid
Lactose monohydrate	Filler and tablet-mass contributor
Povidone	Binder and granulation aid
Crospovidone	Disintegrant, particularly for the immediate-release component
Colloidal silicon dioxide	Glidant and moisture-flow aid
Magnesium stearate	Lubricant
Sodium lauryl sulfate	Wetting or processing aid
Titanium dioxide	Opacifier and colorant

The precise quantitative composition is proprietary and may differ by manufacturer, NDC, or manufacturing site. Public labeling generally does not disclose the amount of each excipient or the architecture of the bilayer, matrix, coating, or compressed-unit system.

The critical technical issue is the separation of release functions. Cetirizine is typically intended to become available promptly, while pseudoephedrine must be released over an extended interval. A formulation that relies on a hydrophilic polymer matrix must control water penetration, gel formation, erosion, drug diffusion, and tablet-to-tablet variability.

Which excipients create the greatest formulation value?

Hypromellose and other release-control polymers

Hypromellose is the central excipient opportunity. Polymer grade, viscosity, particle size, substitution pattern, concentration, and hydration behavior can materially affect pseudoephedrine release.

A commercial developer can pursue:

• Lower-viscosity hypromellose for faster hydration and improved processability.
• Higher-viscosity grades for stronger release retardation.
• Polymer blends to reduce sensitivity to compression force.
• Direct-compression grades to eliminate wet granulation.
• Coated matrix particles to improve release uniformity.
• Polyethylene oxide or modified cellulose alternatives where regulatory and supply-chain economics support the change.

The strongest formulation position is not the use of hypromellose alone. It is a reproducible relationship among polymer grade, drug loading, tablet hardness, porosity, coating, and dissolution profile.

Microcrystalline cellulose and compression aids

Pseudoephedrine HCl has a high active load relative to the tablet mass. Microcrystalline cellulose can improve compactibility and reduce capping, lamination, and friability problems. A manufacturer may create value by using a high-functionality cellulose grade that supports direct compression and reduces granulation steps.

Potential benefits include:

• Higher tablet throughput.
• Lower water consumption.
• Reduced drying energy.
• Lower batch variability.
• Better resistance to mechanical damage during packaging and distribution.

The principal risk is that changes in porosity and tablet hardness can alter the release curve. Compression optimization must therefore be linked to dissolution testing rather than tablet-strength testing alone.

Lactose and lactose-free alternatives

Lactose is economically attractive but creates a market-positioning limitation for consumers who avoid lactose or prefer dairy-free products. Replacing lactose with mannitol, anhydrous dibasic calcium phosphate, additional microcrystalline cellulose, or a co-processed filler could support a lactose-free version.

The substitution must be evaluated for:

• Tablet weight.
• Moisture sensitivity.
• Compactability.
• Powder flow.
• Mouthfeel if partial tablet dissolution occurs.
• Pseudoephedrine release.
• Cost per dose.

A lactose-free claim can have stronger retail value than a small active-ingredient change because store-brand allergy products compete heavily on package communication and perceived tolerability.

Lubricants and processing aids

Magnesium stearate is effective but can create over-lubrication risk. Excessive lubrication may reduce tablet tensile strength and slow liquid penetration into a hydrophilic matrix. The opportunity is to optimize lubricant concentration, blending time, and addition sequence.

Alternative or supplemental lubricants, including sodium stearyl fumarate, may improve compression performance in some processes. Any substitution requires comparative dissolution and stability work because lubricant hydrophobicity can affect release.

Colorants, coatings, and printing systems

Titanium dioxide and opaque film coatings support product identification and light protection. They also add processing steps and can increase consumer concern in markets that favor "clean label" medicines.

A differentiated product could use:

• Minimal-color or white-only tablets.
• Iron oxide pigments where permitted and commercially appropriate.
• A thin functional coat that improves swallowability.
• Low-tack film systems for high-speed packaging.
• Embossing or imprinting that improves product recognition.

A coating change is commercially useful only if it improves handling, identification, or patient acceptance without changing dissolution performance.

What formulation strategies could improve commercial performance?

Smaller extended-release tablets

The combination has a substantial pseudoephedrine load. Tablet size is a major adherence issue, especially for patients taking multiple cold or allergy medicines. A smaller tablet could be achieved through:

• Higher-density excipients.
• Coated active particles.
• More efficient matrix design.
• Bilayer compression.
• Granulation that increases bulk density.
• Lower excipient overage while maintaining process control.

A smaller tablet is likely to be more commercially meaningful than a marginal reduction in manufacturing cost. It also supports premium positioning against large store-brand tablets.

Bilayer or multilayer delivery

A bilayer tablet could separate immediate-release cetirizine from extended-release pseudoephedrine. This architecture may provide greater control over early cetirizine availability and prolonged pseudoephedrine release.

Potential advantages include:

• Reduced active-ingredient interaction.
• Independent optimization of each drug layer.
• Easier control of release profiles.
• Better development rationale for formulation claims.

The main disadvantages are higher capital costs, more complex manufacturing, and increased risk of layer adhesion, weight variation, and delamination.

Abuse-deterrent and tamper-resistant design

Pseudoephedrine is subject to federal retail controls under the Combat Methamphetamine Epidemic Act. The product is not generally positioned as an abuse-deterrent medicine, but manufacturers can consider packaging and dosage-form controls that limit tampering.

Potential measures include:

• Unit-dose blister packaging.
• Tamper-evident cartons.
• Serialized or retailer-controlled packaging.
• Tablets that resist powdering or crushing.

These measures do not eliminate legal purchase restrictions and should not be marketed as abuse deterrence without appropriate regulatory support.

Allergen and excipient positioning

A formulation excluding lactose, artificial colors, or specific surfactants could create a differentiated private-label product. Claims must be supported by the complete formulation and manufacturing controls.

Potential claims include:

• Lactose-free.
• Gluten-free, where supported by ingredient and facility controls.
• Dye-free.
• Sugar-free, although sugar is generally not central to this tablet format.
• Preservative-free, because the product is a solid oral dosage form.

"Dye-free" and "lactose-free" are more commercially actionable than broad clean-label language. Retailers can use these features in shelf tags, e-commerce filters, and planogram segmentation.

What FDA regulatory requirements apply to the excipient strategy?

Cetirizine-pseudoephedrine extended-release tablets require more than a simple active-ingredient identity assessment. The sponsor must establish that the reformulated product remains pharmaceutically equivalent and bioequivalent to the reference product or otherwise satisfies the applicable FDA pathway.

Key regulatory areas include:

Regulatory issue	Practical requirement
Active ingredients	Correct identity, strength, and quality
Dosage form	Extended-release tablet consistency
Dissolution	Discriminating method capable of detecting release changes
Bioequivalence	Comparative pharmacokinetic performance where required
Stability	Shelf-life support under applicable ICH and FDA conditions
Inactive ingredients	Safety and compatibility assessment
Labeling	FDA Drug Facts compliance
Manufacturing	cGMP controls and process validation
Pseudoephedrine controls	Sales, recordkeeping, storage, and quantity limitations
Packaging	Tamper evidence and child-resistant requirements where applicable

A major development error would be to treat an excipient substitution as a low-risk change simply because the active ingredients and strengths remain unchanged. In an extended-release product, excipients control the drug-release mechanism. A formulation change may trigger comparative dissolution, pharmacokinetic, stability, and regulatory filing requirements.

FDA guidance on modified-release solid oral dosage forms emphasizes the importance of dissolution testing, formulation characterization, and in vivo performance where release changes can affect exposure.[2] The FDA inactive-ingredient database is useful for assessing prior use of proposed excipients and routes of administration, but it does not replace product-specific safety and equivalence work.[3]

What patent protection applies to the excipient strategy?

The basic cetirizine-pseudoephedrine combination is mature and commercially established. The principal intellectual-property opportunity is therefore a formulation or manufacturing patent, not a new composition-of-matter patent on either active ingredient.

Potential claim categories include:

1. A specific extended-release matrix using defined polymer grades and concentration ranges.
2. A bilayer tablet with independent cetirizine and pseudoephedrine release zones.
3. A coated-particle or multiparticulate delivery system.
4. A tablet with a defined dissolution profile across multiple time points.
5. A smaller tablet achieving a specified drug load and release curve.
6. A lactose-free or dye-free formulation with defined physical properties.
7. A manufacturing process that reduces weight variation or improves content uniformity.
8. A tamper-resistant tablet or package.

Patent strength depends on technical specificity. A broad claim to "cetirizine, pseudoephedrine, and hypromellose" is likely vulnerable if prior art discloses the same combination and polymer class. Stronger protection would tie the claim to measurable performance, such as a defined dissolution profile, tablet architecture, polymer viscosity range, or process parameter combination.

Before filing, an applicant would need a freedom-to-operate review covering:

• Zyrtec-D and related formulation patents.
• Generic extended-release cetirizine-pseudoephedrine products.
• Polymer matrix and bilayer tablet patents.
• Coated-particle delivery technologies.
• Manufacturing patents held by contract manufacturers.
• U.S., European, Canadian, and other jurisdictional family members.

Because OTC and generic products may not have a robust Orange Book patent listing, a patent search should cover Google Patents, USPTO Patent Center, FDA Orange Book records, and relevant litigation databases.

What is the Orange Book and Paragraph IV risk?

The Orange Book status depends on the specific product's regulatory pathway and NDC. A product marketed under an ANDA may have an Orange Book entry if the corresponding application and dosage form are listed. A product marketed under an OTC monograph pathway may not have the same listing profile.

For a reformulated product, the main legal risks are:

• A new formulation patent could be challenged by a later ANDA applicant.
• A Paragraph IV certification could trigger patent litigation if an Orange Book-listed patent is identified.
• A non-listed patent may still support ordinary patent litigation, but it does not automatically create the same Hatch-Waxman stay mechanics.
• A formulation change may require a new ANDA, supplement, or other FDA filing depending on the product's regulatory basis.

The commercial barrier from pseudoephedrine controls is distinct from patent exclusivity. Even after patent expiry, a generic launch must comply with federal purchase limits, point-of-sale controls, identification requirements, record retention, and state-specific rules.[4]

When does Good Sense All Day Allergy D lose exclusivity?

The active ingredients are long-established, and the product does not appear to depend on new chemical-entity exclusivity. Commercial exclusivity is therefore driven by:

• Brand recognition.
• Retailer placement.
• Private-label contracts.
• Manufacturing scale.
• Formulation know-how.
• Any unexpired formulation or process patents.
• FDA approval status for the specific generic product.
• Pseudoephedrine distribution controls.

There is no single meaningful "loss of exclusivity" date for the product without identifying the precise NDC, labeler, application number, and patent estate. The practical market is already genericized, with private-label competition established.

Which companies challenge or compete with Good Sense All Day Allergy D?

The competitive set includes:

Competitor type	Representative products or participants
National brand	Zyrtec-D 24 Hour
Retail private labels	CVS Health, Walgreens, Walmart, Target, Rite Aid, and supermarket brands
Generic manufacturers	Companies marketing cetirizine-pseudoephedrine extended-release tablets through approved applications
Alternative antihistamines	Loratadine-pseudoephedrine and fexofenadine-pseudoephedrine products
Non-systemic alternatives	Intranasal corticosteroids, intranasal antihistamines, and topical decongestants
Non-drug substitutes	Saline irrigation and environmental allergy controls

Zyrtec-D has the strongest direct brand association. Store brands compete through lower price, equivalent active ingredients, retailer loyalty, and availability behind the pharmacy counter.

The main substitution risk is not only another cetirizine-pseudoephedrine tablet. Consumers may shift to separate cetirizine and pseudoephedrine products, especially when retailers offer larger package sizes or lower unit pricing.

What commercial opportunities exist for excipient-led reformulation?

Retailer-specific private-label platforms

A manufacturer can offer a common active-ingredient core with several excipient and package variants:

• Standard low-cost version.
• Lactose-free version.
• Dye-free version.
• Small-tablet premium version.
• Blister-packed pharmacy version.
• Club-store multipack.

This model can support multiple customers without creating an entirely separate manufacturing process for every retailer.

Contract manufacturing and technology licensing

The most licensable asset would be a validated extended-release platform that offers:

• Direct compression.
• High-speed manufacturing.
• Reduced tablet size.
• Stable dissolution across humidity and compression ranges.
• Easy adaptation to related combinations.

A platform could be extended to pseudoephedrine combinations with loratadine or fexofenadine, subject to regulatory and patent review. Licensing value would depend on demonstrated bioequivalence, scale-up data, and freedom to operate.

Seasonal inventory and geographic coverage

Allergy and respiratory products have seasonal demand patterns, but allergy symptoms can generate year-round sales. Pseudoephedrine restrictions create additional inventory-management requirements because retailers must maintain controlled pharmacy-counter stock.

Geographic expansion requires review of:

• U.S. federal and state pseudoephedrine laws.
• Canadian and European decongestant rules.
• Country-specific OTC classifications.
• Permitted excipients and colorants.
• Local labeling and pack-size requirements.
• Import and distribution controls.

The United States remains the most commercially important market for this exact combination, while international opportunities may favor cetirizine-only products or alternative decongestants.

How should a company prioritize the development program?

A practical sequence is:

Stage	Development objective
1	Confirm the exact reference product, NDC, active strengths, and regulatory pathway
2	Map the current excipient composition and tablet architecture
3	Screen polymer systems and high-density fillers
4	Establish comparative dissolution methods
5	Select lactose-free, dye-free, or small-tablet variants
6	Conduct accelerated and long-term stability studies
7	Evaluate pharmacokinetic equivalence where required
8	File formulation or process patents before public disclosure
9	Complete FDA regulatory submission and pseudoephedrine compliance review
10	Secure retailer or pharmacy-channel contracts

The highest-probability commercial program is a direct-compression or simplified granulation formulation using a robust hypromellose matrix, reduced tablet size, and a lactose-free or dye-free positioning. A bilayer or multiparticulate system may offer stronger patent differentiation but carries greater manufacturing and regulatory complexity.

Key Takeaways

• Good Sense All Day Allergy D is an established cetirizine HCl and pseudoephedrine HCl extended-release product.
• Excipient value is concentrated in release control, tablet size, compression reliability, and consumer-facing tolerability claims.
• Hypromellose, microcrystalline cellulose, lactose, binders, lubricants, and coating systems are the main formulation levers.
• A lactose-free or dye-free version could support retail differentiation, but the claim must match the full formulation and manufacturing process.
• The strongest patent opportunity is a narrowly defined release-control architecture or manufacturing process.
• The product faces mature generic competition and does not rely on new chemical-entity exclusivity.
• Pseudoephedrine purchase and distribution controls remain a commercial barrier after patent rights expire.
• A private-label platform with multiple excipient and packaging variants is the clearest licensing and manufacturing opportunity.

FAQs

Can lactose be removed from Good Sense All Day Allergy D without changing the release profile?

Yes, but the replacement filler can change tablet porosity, hardness, water penetration, and pseudoephedrine release. Comparative dissolution and stability testing are required.

Is a smaller Good Sense All Day Allergy D tablet commercially defensible?

Yes. A smaller tablet can improve swallowability and support a differentiated formulation or process patent if the size reduction is linked to a defined release profile and manufacturing architecture.

Can a dye-free version command a higher retail price?

Potentially. Dye-free positioning can support premium private-label placement, although the commercial benefit depends on retailer segmentation, package communication, and manufacturing cost.

Does pseudoephedrine create patent protection for Good Sense All Day Allergy D?

No. Pseudoephedrine is an established active ingredient. Its main commercial impact comes from federal and state sales controls, not new chemical exclusivity.

Can the formulation be expanded to loratadine-pseudoephedrine products?

A shared manufacturing platform may be possible, but the active ingredients have different physicochemical and release requirements. Separate formulation, bioequivalence, labeling, and freedom-to-operate analyses would be required.

References

1. DailyMed. (n.d.). Cetirizine hydrochloride and pseudoephedrine hydrochloride extended-release tablets, Good Sense All Day Allergy D labeling. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

2. U.S. Food and Drug Administration. (1997). Extended release solid oral dosage forms: Development, evaluation, and application of in vitro/in vivo correlations. https://www.fda.gov/

3. U.S. Food and Drug Administration. (n.d.). Inactive ingredient database. https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm

4. U.S. Drug Enforcement Administration. (n.d.). Combat methamphetamine epidemic act requirements for retail distributors and sellers of pseudoephedrine. https://www.deadiversion.usdoj.gov/ meth/