List of Excipients in Branded Drug ALLERGY RELIEF-D24 HOUR

Generic Drugs Containing ALLERGY RELIEF-D24 HOUR

Company	Ingredient	NDC	Excipient
TOP CARE (Topco Associates LLC)	loratadine and pseudoephedrine sulfate	36800-472	CANDELILLA WAX
TOP CARE (Topco Associates LLC)	loratadine and pseudoephedrine sulfate	36800-472	FERROSOFERRIC OXIDE
TOP CARE (Topco Associates LLC)	loratadine and pseudoephedrine sulfate	36800-472	GLYCERYL MONOSTEARATE
TOP CARE (Topco Associates LLC)	loratadine and pseudoephedrine sulfate	36800-472	HYPROMELLOSE

What are the Most Frequently-Used Excipients in ALLERGY RELIEF-D24 HOUR?

# Of NDCs	Excipient
1	CANDELILLA WAX
1	FERROSOFERRIC OXIDE
1	GLYCERYL MONOSTEARATE
1	HYPROMELLOSE

Last updated: August 3, 2026

ALLERGY RELIEF-D 24 HOUR is an extended-release combination of cetirizine hydrochloride 10 mg and pseudoephedrine hydrochloride 240 mg. Its commercial opportunity is primarily a private-label and retail-channel play, not a conventional patent-protected branded product. The strongest product-development levers are controlled pseudoephedrine release, tablet robustness, moisture control, swallowability, and supply-chain compliance. Public FDA labeling identifies common solid-dose excipients, but the exact formulation and manufacturer must be confirmed against the applicable National Drug Code.

ALLERGY RELIEF-D 24 HOUR Excipient Strategy, Patent Position, and Commercial Opportunities

What is ALLERGY RELIEF-D 24 HOUR?

ALLERGY RELIEF-D 24 HOUR is an oral extended-release allergy and nasal-congestion product containing:

Component	Typical strength	Function
Cetirizine hydrochloride	10 mg	Second-generation antihistamine
Pseudoephedrine hydrochloride	240 mg	Nasal decongestant
Dosage form	One extended-release tablet	24-hour delivery

The product is therapeutically comparable to once-daily cetirizine-pseudoephedrine products such as Zyrtec-D 24 Hour. Cetirizine reduces histamine-mediated allergy symptoms, while pseudoephedrine reduces nasal congestion through systemic vasoconstriction.

The 24-hour format differentiates the product from 12-hour cetirizine-pseudoephedrine tablets containing approximately 120 mg of pseudoephedrine per tablet.

FDA labeling for this product category directs patients to swallow the tablet whole and not crush, chew, or split it. That instruction makes the release-controlling matrix or coating central to product performance and regulatory equivalence [1].

What excipients are used in ALLERGY RELIEF-D 24 HOUR?

Public labels for cetirizine-pseudoephedrine extended-release tablets identify excipients commonly used in direct-compression or coated modified-release tablets. Depending on the manufacturer, the formulation may contain:

• Microcrystalline cellulose
• Hypromellose
• Povidone
• Colloidal silicon dioxide
• Magnesium stearate
• Crospovidone or another disintegrant
• Polyethylene glycol
• Titanium dioxide
• Talc
• Lactose or another diluent

The exact inactive-ingredient profile is manufacturer-specific. FDA’s Inactive Ingredient Database and the product’s DailyMed label provide the relevant regulatory record for the marketed NDC [2,3].

What does each excipient do?

Excipient category	Commercial and technical role
Microcrystalline cellulose	Filler, compression aid, and tablet-strength enhancer
Hypromellose	Matrix former or film-coating polymer for extended release
Povidone	Binder that improves granule and tablet cohesion
Colloidal silicon dioxide	Glidant and moisture-flow aid
Magnesium stearate	Lubricant used during compression
Crospovidone	Disintegration aid, where compatible with the release design
Polyethylene glycol	Plasticizer or coating component
Titanium dioxide	Opacifier and appearance modifier
Talc	Anti-sticking or coating aid
Lactose	Diluent that can reduce formulation cost and improve tablet mass

The formulation must balance two conflicting requirements. Cetirizine must become available rapidly enough to provide antihistamine activity, while pseudoephedrine must release over approximately 24 hours. A single matrix system can accomplish both functions, but the active ingredients have different dose levels and physicochemical properties. Pseudoephedrine represents most of the tablet’s active mass, which makes its release profile the principal formulation challenge.

How should the excipient strategy be designed?

Control pseudoephedrine release

Pseudoephedrine hydrochloride is highly water soluble. Without an effective release-control system, it can dissolve rapidly and produce an undesirable initial release. A hydrophilic hypromellose matrix is a practical platform because the polymer hydrates at the tablet surface and creates a diffusion and erosion barrier.

A commercial development program should screen:

1. Hypromellose viscosity grades.
2. Polymer concentration.
3. Tablet hardness and compression force.
4. Granulation method.
5. Coating weight.
6. Dissolution sensitivity to agitation and pH.
7. Release behavior after tablet splitting or crushing.

A high-viscosity hypromellose grade may extend release but can increase tablet size, slow processing, and create manufacturing variability. A lower-viscosity grade can improve manufacturability but may require a coating or additional matrix former.

Separate the immediate and extended-release functions

A multipart or bilayer design could place cetirizine in an immediate-release portion and pseudoephedrine in an extended-release portion. This approach can provide greater control over the pharmacokinetic profile than a uniform matrix.

A bilayer tablet may offer:

• Faster cetirizine availability.
• More predictable pseudoephedrine release.
• Lower dependence on a single polymer concentration.
• A clearer platform for future line extensions.

The tradeoff is higher manufacturing complexity, more demanding process controls, and greater risk of layer separation or weight variation.

Improve swallowability

A 24-hour tablet can be relatively large because of the 240 mg pseudoephedrine dose and the polymer matrix. Opportunities include:

• Higher-density excipient systems.
• Coated mini-tablets placed in a capsule.
• Multiparticulate beads.
• Bilayer compression.
• Low-moisture granulation.
• Film coatings that reduce friction and improve mouthfeel.

The product must retain its extended-release characteristics. Any size reduction that increases patient convenience must not create a dose-dumping risk.

Manage moisture and stability

Hypromellose, povidone, and some disintegrants can affect moisture uptake. Moisture may alter tablet hardness, coating integrity, dissolution, and physical stability.

Priority controls include:

• Low-moisture excipients.
• Moisture-barrier film coating.
• High-barrier blister packaging.
• Desiccant-containing bottles where justified.
• Relative-humidity controls during compression and packaging.
• Stability testing under FDA and ICH conditions.

Pseudoephedrine products also require strong inventory controls because of diversion concerns. Packaging should support unit accountability, tamper evidence, and retail compliance.

What patents protect ALLERGY RELIEF-D 24 HOUR?

The principal historical intellectual-property protection for the cetirizine-pseudoephedrine extended-release combination related to the combination product and its controlled-release presentation. The original branded product was associated with U.S. patent protection covering cetirizine and pseudoephedrine in an extended-release dosage form. Those original U.S. rights have expired, eliminating the principal patent barrier to generic and store-brand competition.

The commercial product is therefore more likely to be protected by:

• Manufacturer-specific formulation know-how.
• Process parameters.
• Dissolution specifications.
• Coating technology.
• Supplier relationships.
• Trade dress and trademarks.
• Product-specific regulatory records.

Does ALLERGY RELIEF-D 24 HOUR have Orange Book protection?

An OTC product of this type generally does not have the same Orange Book patent-listing profile as a prescription drug approved under a conventional NDA. FDA’s Orange Book is principally focused on approved prescription and certain other NDA products, while many nonprescription products are marketed under OTC monographs or approved applications with limited public patent relevance [4].

As a result, an entrant should not assume that absence of an Orange Book listing means absence of all intellectual-property risk. The relevant review should include:

• FDA approval history.
• OTC monograph status.
• Listed drug status.
• U.S. formulation patents.
• Foreign patent families.
• Trademark rights.
• Manufacturer-specific technical disclosures.

When does ALLERGY RELIEF-D 24 HOUR lose exclusivity?

The product’s principal historical exclusivity has already expired in the United States. Cetirizine became broadly available as a generic antihistamine, and pseudoephedrine has long been available from multiple manufacturers. The combination product is therefore commercially open to private-label and generic competition, subject to FDA requirements and pseudoephedrine controls.

There is no meaningful current exclusivity period comparable to a new chemical entity, biologic reference product, or recently approved prescription combination.

Is there a Paragraph IV challenge risk?

Paragraph IV litigation risk is limited when the product is marketed as an OTC or non-Orange-Book-listed product. A generic applicant challenging an Orange Book-listed patent would use an abbreviated new drug application and could submit a Paragraph IV certification. For this product category, the more common path is an OTC monograph route, an approved ANDA where applicable, or another FDA-recognized pathway tied to the specific product and listing history.

The practical risk is formulation and regulatory equivalence, not an active branded patent campaign.

What FDA regulatory issues affect commercial launch?

Pseudoephedrine is subject to federal retail controls under the Combat Methamphetamine Epidemic Act. Retailers must maintain sales records, enforce daily and monthly purchase limits, verify purchaser information, and secure inventory. State requirements can be stricter [5].

A launch strategy must account for:

Regulatory area	Commercial implication
Pseudoephedrine sales controls	Limits retail availability and requires compliance systems
Extended-release labeling	Requires whole-tablet administration instructions
OTC labeling	Drug Facts, warnings, age restrictions, and contraindications
Hypertension and cardiovascular warnings	Influences target consumers and pharmacist counseling
Antihistamine warnings	Drowsiness and alcohol-related labeling may apply
Product quality	Dissolution and assay consistency are critical
Packaging	Tamper evidence and diversion controls increase cost

The product is less suitable for unrestricted e-commerce than a cetirizine-only product because pseudoephedrine sales may require age verification, quantity tracking, and retailer-specific controls.

What commercial opportunities exist for ALLERGY RELIEF-D 24 HOUR?

Private-label retail

The clearest opportunity is a retailer-branded product sold through pharmacy chains, grocery stores, warehouse clubs, and regional drugstores. Retailers can use the product to compete with branded Zyrtec-D 24 Hour on price while preserving a recognizable dual-symptom proposition.

The main commercial advantages are:

• Established active ingredients.
• No new chemical entity development.
• Familiar therapeutic category.
• Simple once-daily dosing.
• Strong seasonal demand.
• Potential for retailer-exclusive packaging.

Contract manufacturing

A manufacturer with validated extended-release capabilities can offer a turnkey platform covering:

• API sourcing.
• Granulation or direct compression.
• Film coating.
• Dissolution testing.
• Packaging.
• NDC support.
• Retailer-specific artwork.

The strongest suppliers will have experience with high-dose soluble APIs and controlled-release tablets. Manufacturing capacity is more valuable when it includes pseudoephedrine compliance and serialization capabilities.

Line extensions

Potential extensions include:

• 12-hour tablets.
• Liqui-gel or capsule formats.
• Smaller tablets or mini-tablets.
• Seasonal multi-packs.
• Cetirizine-only and pseudoephedrine-only companion products.
• International formulations using local decongestants.
• Sugar-free or lactose-free variants where consumer demand supports them.

A pediatric extension would require separate safety and dosing support and should not be treated as a simple reformulation.

Geographic expansion

The United States has a distinctive pseudoephedrine regulatory environment. International expansion requires separate review of:

• Whether pseudoephedrine is permitted.
• Prescription versus nonprescription status.
• Maximum daily dose.
• Approved antihistamine combinations.
• Local labeling language.
• Import and controlled-substance rules.
• Local excipient restrictions.

In some markets, phenylephrine or another decongestant may be used instead, but that would create a different product and require separate efficacy, safety, and regulatory analysis.

How strong is the formulation and manufacturing barrier?

The patent barrier is weak because the historical combination-product exclusivity has expired. The technical barrier is moderate.

Key development risks are:

1. Failure to match the reference dissolution profile.
2. Dose dumping under altered pH or high agitation.
3. Tablet size that reduces adherence.
4. Moisture-driven stability changes.
5. Manufacturing variation in polymer distribution.
6. Pseudoephedrine supply and compliance constraints.
7. Retail limitations caused by behind-the-counter controls.

A differentiated product can create commercial value without relying on a new patent. Useful protection may come from a novel coating, multiparticulate architecture, improved stability, or a manufacturing process that produces a demonstrably better product. Any patent strategy should focus on specific formulation or process claims rather than broad claims to cetirizine and pseudoephedrine alone.

How does ALLERGY RELIEF-D 24 HOUR compare with competing products?

Product category	Main actives	Dosing	Competitive position
Allergy Relief-D 24 Hour	Cetirizine plus pseudoephedrine	Once daily	Broad allergy and congestion coverage
Zyrtec-D 24 Hour	Cetirizine plus pseudoephedrine	Once daily	Branded reference and premium benchmark
Claritin-D 24 Hour	Loratadine plus pseudoephedrine	Once daily	Direct antihistamine-combination competitor
Allegra-D 24 Hour	Fexofenadine plus pseudoephedrine	Once daily	Non-sedating positioning
Cetirizine-only tablets	Cetirizine	Once daily	Lower-cost option without decongestant
Pseudoephedrine-only products	Pseudoephedrine	Varies	Targeted congestion relief

Cetirizine may have stronger consumer recognition for allergy symptom relief, while loratadine and fexofenadine compete on perceived non-drowsiness. The combination product’s main advantage is convenience for consumers with simultaneous allergic rhinitis and congestion.

What generic launch scenarios exist?

The most likely launch scenarios are:

• Retailer private-label substitution for the branded product.
• Multi-source generic supply through major wholesalers.
• Seasonal promotional pricing.
• Dual sourcing from U.S. and international contract manufacturers.
• Reformulated products with smaller tablets or improved packaging.
• Retailer-specific packs with controlled pseudoephedrine distribution.

Pricing pressure will be high because the actives are mature and the historical patent estate is no longer a major barrier. Gross-margin protection depends on manufacturing yield, tablet count, packaging cost, retailer terms, and supply reliability.

Key Takeaways

• ALLERGY RELIEF-D 24 HOUR is a mature extended-release cetirizine-pseudoephedrine product.
• The likely active-ingredient profile is cetirizine hydrochloride 10 mg plus pseudoephedrine hydrochloride 240 mg per tablet.
• Hypromellose-based release control, compression aids, binders, lubricants, and film-coating materials are the core excipient tools.
• The historical combination-product patent barrier has expired in the United States.
• Orange Book and Paragraph IV exposure is limited relative to a conventional prescription NDA product.
• The strongest opportunities are private label, contract manufacturing, improved swallowability, moisture protection, and retailer-specific packaging.
• Pseudoephedrine controls are a material commercial and operational constraint.
• Formulation and process know-how provide more realistic competitive protection than broad composition claims.

FAQs

Can ALLERGY RELIEF-D 24 HOUR be reformulated without changing the active ingredients?

Yes. A sponsor can evaluate different fillers, binders, matrix polymers, coatings, and packaging systems, provided the product continues to meet FDA quality, labeling, stability, and release requirements.

Is a lactose-free version commercially viable?

Potentially. A lactose-free formulation could address consumers with lactose sensitivity or retailer-specific ingredient policies. The replacement diluent must preserve tablet hardness, dissolution, stability, and manufacturing yield.

Does pseudoephedrine make this product a controlled substance?

Pseudoephedrine is not scheduled as a conventional controlled substance, but federal law imposes sales, recordkeeping, quantity, identification, and storage requirements because it can be diverted for illicit methamphetamine production [5].

Can the product be sold freely through online marketplaces?

Availability depends on the retailer’s verification and pseudoephedrine compliance system. Unrestricted marketplace distribution is less practical than for cetirizine-only products.

What is the most defensible patent strategy for a new competitor?

The strongest strategy would target a specific extended-release architecture, coating system, multiparticulate design, stability improvement, or manufacturing process. Broad claims covering cetirizine plus pseudoephedrine are unlikely to provide meaningful protection against mature generic competition.

References

1. U.S. Food and Drug Administration. (n.d.). DailyMed: Cetirizine hydrochloride and pseudoephedrine hydrochloride extended-release tablets. National Library of Medicine.

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

3. National Library of Medicine. (n.d.). DailyMed. https://dailymed.nlm.nih.gov/dailymed/

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Center for Drug Evaluation and Research.

5. U.S. Drug Enforcement Administration. (n.d.). Pseudoephedrine, ephedrine, and phenylpropanolamine: Retail sales requirements. https://www.deadiversion.usdoj.gov/phrma/epsupplements.html