List of Excipients in Branded Drug GOOD SENSE ALLER EASE

Generic Drugs Containing GOOD SENSE ALLER EASE

Company	Ingredient	NDC	Excipient
L Perrigo Company	fexofenadine hcl	0113-0425	CELLULOSE, MICROCRYSTALLINE
L Perrigo Company	fexofenadine hcl	0113-0425	CROSCARMELLOSE SODIUM
L Perrigo Company	fexofenadine hcl	0113-0425	FERRIC OXIDE RED
L Perrigo Company	fexofenadine hcl	0113-0425	FERRIC OXIDE YELLOW
L Perrigo Company	fexofenadine hcl	0113-0425	FERROSOFERRIC OXIDE

What are the Most Frequently-Used Excipients in GOOD SENSE ALLER EASE?

# Of NDCs	Excipient
3	CELLULOSE, MICROCRYSTALLINE
3	CROSCARMELLOSE SODIUM
1	FD&C BLUE NO. 2 ALUMINUM LAKE
1	FD&C RED NO. 40
1	FD&C YELLOW NO. 6

Good Sense Aller-Ease Excipient Strategy and Commercial Opportunities

Last updated: September 24, 2026

Good Sense Aller-Ease is a private-label fexofenadine hydrochloride antihistamine product, generally sold as an over-the-counter 180 mg tablet comparable to Allegra 24 Hour. Its commercial opportunity is not based on active-ingredient exclusivity. Fexofenadine is a mature generic molecule with broad supplier availability, low formulation barriers, and intense private-label competition. The strongest opportunities are cost-efficient tablet manufacture, improved swallowability, differentiated dosage forms, combination products, and retail-channel optimization.

Excipient strategy should prioritize rapid disintegration, low tablet weight, coating robustness, moisture control, and reliable high-volume compression. A manufacturer can obtain commercial advantage through supply-chain economics and product experience rather than through conventional composition-of-matter patents.

What is Good Sense Aller-Ease?

Good Sense Aller-Ease is a store-brand allergy medicine containing fexofenadine hydrochloride, a second-generation H1 antihistamine. The product is used for temporary relief of allergy symptoms, including sneezing, runny nose, itchy or watery eyes, and itchy nose or throat.

Attribute	Product profile
Brand	Good Sense Aller-Ease
Product type	OTC antihistamine
Active ingredient	Fexofenadine hydrochloride
Common strength	180 mg
Therapeutic category	Second-generation H1 antihistamine
Reference brand	Allegra 24 Hour
Typical dosing	Once daily for adults and children 12 years and older
Primary dosage form	Immediate-release tablet
Commercial channel	Retail, pharmacy, grocery, club, and e-commerce private label
Regulatory pathway	OTC drug product supported by an applicable FDA monograph or approved generic framework, depending on the specific product and label

The exact inactive-ingredient list can vary by supplier, strength, tablet appearance, coating system, and manufacturing site. A final excipient assessment should therefore be tied to the applicable Drug Facts label and FDA product record.

What excipients are used in Good Sense Aller-Ease?

Publicly marketed fexofenadine tablets commonly use standard solid-dose excipients rather than novel delivery technologies. The formulation architecture generally includes:

Excipient function	Common excipient classes	Commercial purpose
Diluent	Microcrystalline cellulose, lactose, starch, or dibasic calcium phosphate	Provides tablet mass and improves compression
Binder	Povidone or pregelatinized starch	Improves granule and tablet cohesion
Disintegrant	Croscarmellose sodium, sodium starch glycolate, or crospovidone	Promotes rapid tablet breakup
Glidant	Colloidal silicon dioxide	Improves powder flow and die filling
Lubricant	Magnesium stearate or sodium stearyl fumarate	Reduces ejection force and tooling friction
Film coating	Hypromellose, polyethylene glycol, titanium dioxide, colorants	Improves appearance, swallowability, and handling
Opacifier or colorant	Titanium dioxide, iron oxides, or approved color systems	Supports product identification and brand differentiation

The key formulation issue is not solubility alone. Fexofenadine hydrochloride must be combined with excipients that maintain adequate dissolution after compression, coating, storage, and exposure to variable humidity.

Which excipients are most important for fexofenadine tablets?

Disintegrant selection is commercially important because a high-dose 180 mg tablet can become dense and slow to break apart if compression force is excessive. Croscarmellose sodium and crospovidone are strong candidates for direct compression or dry-granulation systems because they provide rapid liquid penetration and tablet breakup at relatively low use levels.

Microcrystalline cellulose can provide both dilution and compaction. It is often attractive for high-volume private-label manufacture because it supports direct compression and reduces process complexity. The tradeoff is sensitivity to moisture and batch-to-batch variability in powder properties.

Magnesium stearate is effective at low concentrations but can reduce wettability and dissolution if over-lubrication occurs. Lubrication time should be tightly controlled, particularly when using a high-shear blending process.

A film coat based on hypromellose can improve swallowability without materially changing the immediate-release profile. The coating should remain thin enough to prevent delayed disintegration and should not introduce unnecessary moisture into the core.

How should the excipient strategy be optimized?

Direct compression versus granulation

Direct compression is likely the preferred manufacturing platform for a mature fexofenadine tablet if the powder blend has adequate flow, content uniformity, and compactability. It reduces equipment demand, processing time, and water exposure.

Dry granulation is a practical alternative when the blend has poor flow or segregation risk. It can improve uniformity and feeding performance without introducing the drying step required for wet granulation.

Wet granulation is less attractive for a conventional immediate-release private-label product unless development data show a clear benefit. It adds drying, energy, validation, and moisture-control requirements.

Manufacturing approach	Advantages	Risks
Direct compression	Lowest process cost, short cycle time, limited moisture exposure	Flow, segregation, and compactability risks
Dry granulation	Better flow and density control, no aqueous drying	Roller-compaction impact on dissolution and tablet tensile strength
Wet granulation	Strong granule control and content uniformity	Higher cost, longer process, moisture and drying burden

Target quality attributes

The formulation should be designed around:

• Assay and content uniformity
• Immediate-release dissolution
• Low friability
• Adequate hardness without delayed disintegration
• Consistent tablet weight
• Coating uniformity
• Stability under high-temperature and high-humidity conditions
• Low tablet-to-tablet variability
• Acceptable swallowability for once-daily use

A practical development strategy is to establish a disintegration and dissolution design space rather than maximizing hardness. Excessive hardness can reduce product performance while providing little retail value.

What commercial opportunities exist for Good Sense Aller-Ease?

1. Cost leadership in standard tablets

The largest immediate opportunity is a low-cost 180 mg tablet using a conventional excipient system. Retailers often compete on shelf price, package count, and price per dose. A formulation that supports direct compression, high-speed coating, and low rejection rates can improve gross margin without changing the consumer-facing product.

Cost reduction levers include:

• Fewer excipient grades
• Dual-function excipients
• Direct compression
• Lower coating weight
• Larger production batches
• Standardized tooling
• Regional or dual-source excipient procurement
• Packaging-line simplification

The commercial value is strongest for 30-, 60-, 90-, and 180-count packages, where packaging and distribution efficiency materially affect unit economics.

2. Larger-count value packages

Fexofenadine is a once-daily product, making it suitable for larger-count packaging. A 180-count package can compete in club and e-commerce channels, while 90-count packaging can target pharmacy and grocery retail.

The excipient formula may remain unchanged, but packaging requirements become more important. Moisture protection, tablet abrasion, bottle fill efficiency, and child-resistant closure compatibility can determine whether a large-count package performs reliably.

3. Chewable tablets

A chewable fexofenadine product can target consumers who have difficulty swallowing conventional tablets and pediatric users within the approved age range. The excipient strategy would shift toward:

• Sweeteners
• Flavors
• Taste-masking agents
• Mannitol or similar mouthfeel modifiers
• More robust tablet structure
• Controlled friability
• Reduced grittiness

Chewables create more formulation complexity because fexofenadine must be acceptable in the mouth. Taste masking can require additional excipients and may reduce tablet compactability. The commercial opportunity is greater if the product can achieve a favorable taste profile without materially increasing tablet size.

4. Orally disintegrating tablets

An orally disintegrating tablet could differentiate the product through convenience. The key excipient requirements are rapid wetting, low-residue mouthfeel, mechanical strength, and packaging protection.

Potential technologies include direct-compression ODTs and freeze-dried systems. Direct compression is more compatible with private-label cost targets. Freeze-dried dosage forms may offer rapid disintegration but have higher packaging and manufacturing costs.

An ODT would require careful control of:

• Disintegration time
• Tablet friability
• Moisture uptake
• Mouthfeel
• Unit-dose packaging
• Dissolution equivalence
• Stability after package opening

5. Fexofenadine-pseudoephedrine combinations

Combination allergy products can command higher price points and address congestion, a symptom not directly treated by fexofenadine alone. The principal candidate is a fexofenadine and pseudoephedrine extended-release product.

This opportunity has greater technical and regulatory complexity. The formulation must manage two release profiles, avoid dose dumping, and account for pseudoephedrine regulatory controls. The product may require a more complex drug application and stronger abuse-prevention and inventory-control procedures than a standard fexofenadine tablet.

6. Liquid and pediatric products

An oral suspension or solution can address younger patients and consumers who cannot swallow tablets. Excipient requirements include:

• Suspending agents or solubilizers
• Preservatives where appropriate
• Sweeteners and flavors
• pH adjustment
• Sedimentation control
• Redispersibility
• Dosing-device accuracy

Liquid products carry higher microbiological, packaging, shipping, and stability risks. They may still offer commercial value because they compete in a less commoditized segment than standard tablets.

What regulatory and Orange Book issues affect the product?

Fexofenadine is a mature active ingredient with extensive generic competition. The commercial product may be marketed under an OTC framework or as a product associated with an approved generic application, depending on the exact manufacturer and product presentation.

The FDA Orange Book is relevant when the product is linked to an approved abbreviated new drug application. The FDA Drug Facts label and DailyMed record are more useful for confirming the marketed formulation, inactive ingredients, dosage form, and labeling.

Regulatory issue	Commercial relevance
OTC monograph compliance	Can reduce development and application burden for eligible products
ANDA status	May determine Orange Book listing and substitution treatment
Drug Facts labeling	Controls permitted claims and consumer instructions
Inactive-ingredient review	Important for route, dosage form, and safety assessment
Bioequivalence or comparative performance	Relevant where the product follows an approved generic pathway
Manufacturing-site compliance	Affects supply continuity and retail launch timing

When does fexofenadine lose exclusivity?

Fexofenadine has already entered the mature generic and private-label phase. The main market barriers are therefore regulatory compliance, manufacturing capacity, retailer qualification, quality history, and supply reliability rather than basic molecule exclusivity.

For a standard immediate-release tablet, a new entrant generally faces:

• Low active-ingredient barriers
• Limited formulation differentiation
• Strong retail price competition
• Established generic suppliers
• Low switching costs for retailers
• Potentially significant volume requirements

Fexofenadine hydrochloride products are not comparable to biologics, where biosimilar interchangeability, reference-product exclusivity, and manufacturing complexity create higher entry barriers.

What patent protection covers fexofenadine products?

The original fexofenadine composition-of-matter and core product protection are expired or commercially exhausted in the United States. Residual intellectual-property opportunities may involve:

• Specific combinations
• Modified-release delivery
• Taste-masked dosage forms
• ODT or chewable compositions
• Manufacturing processes
• Solid-state forms
• Packaging systems
• Narrow method-of-use claims

These rights are unlikely to prevent standard immediate-release tablet entry unless they cover the precise commercial formulation and remain enforceable in the target jurisdiction.

A new excipient composition may be patentable only if it provides a non-obvious technical benefit, such as improved stability, dissolution, taste masking, or manufacturability. A simple substitution of one conventional diluent or disintegrant for another is unlikely to create strong exclusionary value without comparative performance data.

How strong is the patent estate for Good Sense Aller-Ease?

The patent estate around a conventional Good Sense Aller-Ease tablet is likely weak from a blocking perspective. The commercial product is based on a mature active ingredient and standard immediate-release technology.

Patent strength is better evaluated across four dimensions:

Dimension	Assessment
Active-ingredient protection	Low; mature generic molecule
Standard tablet formulation	Low to moderate, depending on specific claims
Differentiated dosage forms	Moderate if supported by meaningful performance data
Manufacturing process	Moderate if the process reduces cost or improves quality and is difficult to design around

Trade secrets may be more valuable than patents for a private-label product. These can include compression settings, coating parameters, supplier specifications, blend-order controls, and stability know-how.

Which companies compete with Good Sense Aller-Ease?

Competition comes from several groups:

1. Branded fexofenadine products, led by Allegra.
2. National generic manufacturers.
3. Retail private-label suppliers.
4. Club-store and e-commerce brands.
5. Combination-product manufacturers selling fexofenadine with pseudoephedrine.
6. Alternative antihistamine brands containing cetirizine or loratadine.

Product category	Main competitive advantage
Branded Allegra	Consumer recognition and retail positioning
Generic fexofenadine	Lower price
Good Sense Aller-Ease	Private-label value and retailer control
Cetirizine products	Strong allergy efficacy perception and broad availability
Loratadine products	Price, familiarity, and extensive private-label supply
Fexofenadine-pseudoephedrine	Added congestion relief

The most direct competition is not patent litigation. It is retail placement, price-per-dose, package count, seasonal inventory management, and supplier fill rate.

What generic launch risks exist?

A new entrant should expect the following risks:

• Retailer margin pressure
• Seasonal demand volatility
• Product substitution among antihistamines
• Active-ingredient supply interruptions
• Excipient shortages
• Dissolution failures caused by over-lubrication or excessive compression
• Packaging damage in high-count bottles
• Consumer rejection of large or difficult-to-swallow tablets
• Limited differentiation in standard tablet formats

The best launch profile is a reliable, low-cost product with a differentiated package architecture or dosage form. A conventional tablet without a price, count, channel, or formulation advantage may struggle to gain shelf space.

What is the best excipient and commercial strategy?

For a standard 180 mg tablet, the strongest strategy is:

1. Use a direct-compression or dry-granulation platform.
2. Select a robust superdisintegrant system.
3. Control magnesium stearate concentration and blending time.
4. Use a thin, moisture-controlled film coat.
5. Validate dissolution across compression and coating ranges.
6. Dual-source critical excipients.
7. Offer multiple count sizes from a common core formulation.
8. Reserve differentiated investment for chewable, ODT, pediatric liquid, or combination products.
9. Protect manufacturing parameters and supplier specifications as trade secrets.
10. Use patents only where comparative data support a real technical advantage.

Key Takeaways

• Good Sense Aller-Ease is a private-label fexofenadine product, generally associated with a 180 mg once-daily tablet.
• Standard tablet excipients should emphasize rapid disintegration, compactability, flow, coating performance, and low manufacturing cost.
• Direct compression is the most commercially attractive process if blend properties support it.
• The core fexofenadine molecule provides little meaningful exclusivity for new entrants.
• Commercial differentiation is more likely through chewables, ODTs, pediatric liquids, large-count packaging, or combination products.
• The strongest defensible assets may be process know-how, supplier control, stability data, and retailer relationships.
• A conventional fexofenadine tablet faces high generic and private-label competition with limited patent-based blocking power.

FAQs About Good Sense Aller-Ease Excipient and Commercial Strategy

Is Good Sense Aller-Ease the same as Allegra?

It is generally a private-label equivalent based on fexofenadine hydrochloride, the active ingredient in Allegra. Inactive ingredients, tablet appearance, packaging, and manufacturing source may differ.

Does Good Sense Aller-Ease contain lactose?

The answer depends on the specific strength and manufacturer. Fexofenadine products can use different diluents, including microcrystalline cellulose, starch, lactose, or inorganic calcium salts. The applicable product label controls.

Can a fexofenadine tablet be reformulated as an ODT?

Yes. An ODT can use superdisintegrants, porous excipients, taste-masking agents, and moisture-protective packaging. The formulation must preserve dissolution, stability, mechanical strength, and acceptable mouthfeel.

Is fexofenadine suitable for a chewable allergy product?

Yes, but taste masking is a central development issue. Sweeteners, flavors, mannitol-type fillers, and coating or granulation approaches may be required to improve palatability.

What is the most valuable commercial improvement for a fexofenadine private-label product?

For a standard tablet, the highest-probability improvement is lower cost per dose with reliable quality and multiple package counts. For higher-margin growth, chewable, ODT, pediatric liquid, and congestion-combination formats offer greater differentiation.

References

1. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/

2. U.S. Food and Drug Administration. (2024). DailyMed: Current medication labeling. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/

3. U.S. Food and Drug Administration. (2024). Over-the-counter monograph drugs. https://www.fda.gov/drugs/over-counter-otc-nonprescription-drugs

4. U.S. Food and Drug Administration. (2018). Guidance for industry: Size, shape, and other physical attributes of generic tablets and capsules. https://www.fda.gov/regulatory-information

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

6. National Library of Medicine. (2024). Fexofenadine hydrochloride drug information. MedlinePlus. https://medlineplus.gov/druginfo/meds/a697035.html