List of Excipients in Branded Drug CARE ONE IBUPROFEN PM

Generic Drugs Containing CARE ONE IBUPROFEN PM

Company	Ingredient	NDC	Excipient
American Sales Company	diphenhydramine citrate and ibuprofen	41520-050	CELLULOSE, MICROCRYSTALLINE
American Sales Company	diphenhydramine citrate and ibuprofen	41520-050	CROSCARMELLOSE SODIUM
American Sales Company	diphenhydramine citrate and ibuprofen	41520-050	FD&C BLUE NO. 2 ALUMINUM LAKE

What are the Most Frequently-Used Excipients in CARE ONE IBUPROFEN PM?

# Of NDCs	Excipient
1	CELLULOSE, MICROCRYSTALLINE
1	CROSCARMELLOSE SODIUM
1	FD&C BLUE NO. 2 ALUMINUM LAKE

CARE ONE Ibuprofen PM: Excipient Strategy and Commercial Opportunities

Last updated: August 24, 2026

CARE ONE Ibuprofen PM is an over-the-counter combination product containing ibuprofen 200 mg and diphenhydramine citrate 38 mg per caplet. Its commercial position is based on low-cost dual-action relief: nighttime pain relief plus a sedating antihistamine. The strongest excipient opportunities are cost reduction, swallowability, coating performance, packaging stability, and differentiated delivery formats rather than new chemical-entity exclusivity.

Public labeling identifies the product as an oral, coated solid dosage form. Product-specific inactive-ingredient details should be verified against the current DailyMed label and manufacturing documentation because private-label OTC products can change manufacturers, suppliers, colors, coatings, and excipient grades over time.[1]

What is CARE ONE Ibuprofen PM?

CARE ONE Ibuprofen PM is a store-brand nighttime pain reliever and sleep-aid combination.

Attribute	Product profile
Brand	CARE ONE
Active ingredients	Ibuprofen 200 mg; diphenhydramine citrate 38 mg
Therapeutic use	Minor aches and pains with nighttime sleeplessness
Dosage form	Oral coated tablet or caplet
Regulatory category	OTC drug
Primary channels	Retail pharmacy, grocery, mass merchandise, e-commerce
Reference-product economics	Genericized, price-sensitive OTC category
Main commercial competitors	Advil PM, Motrin PM, store-brand ibuprofen PM products
Primary differentiation levers	Price, count size, swallowability, packaging, private-label placement, retailer loyalty

Ibuprofen is the nonsteroidal anti-inflammatory drug component. Diphenhydramine citrate is the nighttime sedating component. The formulation must deliver adequate disintegration and dissolution for both actives while maintaining tablet strength and acceptable coating performance.

What excipients are used in CARE ONE Ibuprofen PM?

The product’s publicly listed inactive ingredients include conventional oral solid-dose excipients used for binding, disintegration, lubrication, coating, color, and processing. Depending on the marketed configuration, the label may include materials such as microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, sodium starch glycolate, povidone, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, and colorants.[1]

A representative excipient-function map is below.

Excipient class	Typical materials	Function in the product
Diluent and compression aid	Microcrystalline cellulose	Provides tablet mass and compactability
Binder	Povidone, pregelatinized starch	Improves granule or tablet integrity
Disintegrant	Croscarmellose sodium, sodium starch glycolate	Promotes tablet breakup after ingestion
Glidant	Colloidal silicon dioxide	Improves powder flow
Lubricant	Magnesium stearate	Reduces sticking and ejection force
Film former	Hypromellose	Creates protective and cosmetic coating
Plasticizer or coating aid	Polyethylene glycol	Improves film flexibility
Opacifier	Titanium dioxide	Controls appearance and light protection
Colorant	Approved FD&C or other permitted color	Supports product identification

The exact excipient grade matters. Differences in particle size, moisture content, substitution level, viscosity, peroxide burden, and compaction behavior can change dissolution, tablet hardness, coating defects, and stability.

How should the excipient strategy be optimized?

The best strategy is a robust immediate-release tablet platform that supports high-throughput compression, rapid disintegration, and low manufacturing cost.

1. Use a direct-compression or simplified dry-granulation platform

A direct-compression design can reduce water exposure, processing time, and equipment requirements. Microcrystalline cellulose, spray-dried mannitol, or a co-processed excipient system can improve flow and compactability.

The formulation must account for ibuprofen’s relatively high dose and poor water solubility. Ibuprofen can create blend-uniformity, sticking, and dissolution challenges when the drug substance has unfavorable particle-size or crystal characteristics. Excipient selection should therefore be tied to:

• Ibuprofen particle-size distribution
• Bulk and tapped density
• Blend segregation risk
• Tablet tensile strength
• Punch sticking
• Dissolution at the labeled strength
• Sensitivity to magnesium stearate over-lubrication

A dry-granulation process may provide greater robustness if the active blend has poor flow or if the tablet requires higher mechanical strength.

2. Protect dissolution performance

Ibuprofen is a weak acid with limited aqueous solubility at low pH. Excessive hydrophobic lubrication, high tablet hardness, or an overly dense granule can slow wetting and dissolution.

Key controls include:

• Limiting magnesium stearate concentration and lubrication time
• Selecting a high-efficiency superdisintegrant
• Controlling compression force
• Using a porous filler where necessary
• Maintaining suitable ibuprofen particle size
• Avoiding excessive coating weight gain
• Testing dissolution under relevant pH conditions

A formulation that passes disintegration but shows slow dissolution can create a regulatory and commercial problem. Dissolution performance should be assessed after accelerated and long-term stability, not only on release testing.

3. Optimize the coating for nighttime use

A thin, durable film coat can improve swallowability, appearance, taste masking, and tablet identification. The coating should not delay release of either active.

Commercially useful coating improvements include:

• Lower coating weight gain
• Reduced tack during high-speed coating
• Better resistance to abrasion during bottling
• Lower colorant complexity
• More distinctive tablet identification
• Improved opacity without unnecessary titanium dioxide loading
• Reduced moisture transmission

A smaller, smoother caplet can have greater consumer value than a nominally cheaper tablet if it improves adherence to the recommended dose. This is relevant because nighttime combination products are often used by older consumers and people experiencing pain-related sleep disruption.

4. Control excipient-driven impurities

Excipient selection affects chemical stability. Potential risk areas include:

• Peroxides in povidone or polyethylene glycol
• Moisture-mediated degradation
• Interaction between lubricants and the actives
• Colorant migration
• Coating-related discoloration
• Residual solvents from granulation or coating
• Container-closure moisture ingress

The stability program should monitor assay, related substances, dissolution, water content, tablet appearance, hardness, friability, and microbial quality where applicable.

What formulations are commercially protected or differentiated?

The core CARE ONE Ibuprofen PM product is an immediate-release tablet with limited room for strong formulation exclusivity. The commercial value lies in execution and retailer distribution rather than a defensible patent moat.

Potential formulation extensions include:

Product concept	Commercial rationale	Main technical issue
Small-size caplet	Better swallowability	Requires higher compactability
Easy-open bottle	Older consumers and accessibility	Child-resistant packaging requirements
Unit-dose blister	Travel, adherence, pharmacy placement	Packaging cost and moisture barrier
Liquid-filled softgel	Faster consumer-perceived onset and differentiation	Higher cost and manufacturing complexity
Gel-coated tablet	Improved swallowability	Coating process and stability
Dye-free tablet	Sensitive-consumer positioning	Product identification and appearance
Sugar-free liquid	Alternative dosage form	Solubility, taste, preservative system
Lower-count pack	Trial and convenience	Higher per-dose packaging cost
Club-size bottle	Value retail and e-commerce	Inventory and stability exposure
Dual-language packaging	Expanded retail accessibility	Label-space constraints

A liquid or softgel line extension would require a different excipient architecture. Solubilizers, suspending agents, sweeteners, buffers, preservatives, flavor systems, and viscosity modifiers would become critical. The two active ingredients also present taste and solubility challenges, making such products more expensive than a conventional coated caplet.

When does CARE ONE Ibuprofen PM lose exclusivity?

CARE ONE Ibuprofen PM is positioned as an OTC store-brand product, so its commercial exclusivity is not primarily based on a branded patent term. Ibuprofen and diphenhydramine are long-established active ingredients with extensive generic and OTC competition.

Exclusivity category	Relevance to CARE ONE Ibuprofen PM
New chemical entity exclusivity	None expected
Orphan-drug exclusivity	Not applicable
Pediatric exclusivity	Not expected to be product-specific
New formulation exclusivity	Only if a separately developed and approved product qualifies
Patent-based exclusivity	No public basis identified for a product-specific monopoly
Retailer private-label advantage	Contractual and distribution-based, not statutory
OTC monograph pathway	Central regulatory route for compliant products

The product can compete immediately with other compliant OTC products, subject to manufacturing, labeling, quality, and regulatory requirements. OTC monograph status does not prevent other manufacturers from selling equivalent combinations when they meet applicable conditions.

What is the FDA regulatory status of ibuprofen PM products?

Ibuprofen is regulated as an OTC analgesic under the FDA’s OTC framework. Diphenhydramine is used in OTC nighttime sleep-aid products. Combination products must comply with the applicable monograph conditions, labeling requirements, active-ingredient concentrations, warnings, directions, and dosage limitations.[2][3]

The principal regulatory considerations are:

• Correct active-ingredient strengths
• Permitted indication and consumer population
• Required liver, stomach-bleeding, cardiovascular, and sedation warnings
• Appropriate directions for use
• Child-safety and accidental-ingestion controls
• Conformance of inactive ingredients with applicable safety requirements
• Current Drug Facts labeling
• cGMP compliance
• Stability and finished-product testing

A change to the excipient system can have regulatory consequences if it changes dosage form, release profile, appearance, performance, labeling, or product identity. A manufacturer should treat a major excipient change as a product-change-control program rather than a simple procurement substitution.

What is the Orange Book status of CARE ONE Ibuprofen PM?

A conventional OTC monograph product is generally not managed through the same Orange Book patent-listing model used for prescription drugs approved through an NDA. CARE ONE Ibuprofen PM should not be assumed to have an Orange Book patent estate or Paragraph IV litigation profile.

Are there Paragraph IV challenges?

No product-specific Paragraph IV challenge is identified for CARE ONE Ibuprofen PM on the basis of its ordinary OTC store-brand positioning. Paragraph IV litigation is generally associated with abbreviated new drug applications that challenge patents listed for an NDA product. A compliant OTC monograph product typically competes through the monograph pathway rather than through an ANDA patent challenge.

Are biosimilar risks relevant?

No. CARE ONE Ibuprofen PM is a small-molecule oral solid, not a biologic. Biosimilar substitution, reference-biologic exclusivity, and Purple Book listing issues do not apply.

How strong is the patent estate for CARE ONE Ibuprofen PM?

The direct product patent estate appears weak or commercially immaterial. The active ingredients are mature, and the basic combination is widely available in branded and private-label formats.

Patent risk could become relevant in narrower situations:

• A novel liquid or softgel delivery system
• A genuinely differentiated modified-release product
• A new low-irritation formulation supported by patentable composition claims
• A novel packaging or dispensing system
• A manufacturing process that materially improves stability or yield
• A proprietary excipient combination with unexpected performance

A routine substitution of one binder, disintegrant, lubricant, or film former for another is unlikely to create meaningful patent protection. It may still produce trade-secret value through process controls, supplier specifications, compression parameters, coating conditions, and analytical methods.

Which companies are challenging CARE ONE Ibuprofen PM?

The competitive threat comes from substitute products rather than patent challengers.

Competitor group	Examples	Competitive mechanism
National brands	Advil PM, Motrin PM	Brand recognition and advertising
Retail private labels	CVS Health, Walgreens, Walmart, Target, Kroger and other store brands	Lower price and shelf access
Generic manufacturers	Large OTC and contract manufacturers	Scale and retailer supply
E-commerce sellers	Online private-label products	Search visibility and pack-size variety
Combination substitutes	Acetaminophen PM and other nighttime analgesics	Different active ingredient profile

The most direct risk is retailer substitution. A private-label supplier can lose volume if another contract manufacturer offers a lower landed cost, better service levels, lower complaint rates, or more flexible pack configurations.

What commercial opportunities exist for excipient-led product development?

Premium swallowability

A smaller caplet, smoother coat, or softgel can support a modest price premium. The commercial claim should focus on observable product attributes such as easier swallowing, not unsupported claims of superior efficacy.

Cost-down reformulation

The highest-probability opportunity is a cost-down platform using:

• Fewer excipients
• Higher-functionality co-processed excipients
• Lower coating weight
• More efficient direct compression
• Reduced colorant complexity
• Lower scrap and defect rates
• Standardized excipient grades across multiple OTC products

Savings should be calculated on total cost of goods, including yield, cycle time, cleaning, testing, and packaging-line efficiency.

Retailer-specific configurations

The product can be adapted into:

• 20-count trial packs
• 40- or 50-count standard packs
• 80- or 100-count value packs
• Blister cards
• Club-store multipacks
• Travel packs
• Seasonal cold-and-flu planogram formats

Pack architecture is commercially important because the product competes in a high-volume, low-margin environment.

Dye-free and accessibility positioning

A dye-free tablet, large-print carton, easy-open format, or clearer nighttime-use labeling can create retail differentiation. These changes require review of product identification, packaging rules, child-resistant requirements, and consumer comprehension.

Contract-manufacturing platform

A manufacturer with a validated ibuprofen/diphenhydramine platform could offer multiple retailer versions using the same core blend and different tablet markings, coatings, and pack counts. This lowers development cost and shortens launch timelines while preserving manufacturing consistency.

What generic launch risks exist for CARE ONE Ibuprofen PM?

The product has low legal entry barriers but meaningful operational barriers.

Risk	Impact
Price compression	High; multiple private-label alternatives
Supply interruption	High; retailer service-level penalties
Ibuprofen raw-material volatility	Moderate to high
Diphenhydramine supply constraints	Moderate
Dissolution failure after reformulation	High
Coating defects	Moderate
Labeling or warning error	High
Consumer adverse-event complaints	High
Retailer delisting	High
Patent litigation	Low for the basic product
Biosimilar competition	Not applicable

The most likely launch scenario for a new competitor is a compliant immediate-release caplet introduced through a retailer, distributor, or e-commerce channel. The product would need a lower cost, better pack economics, stronger service levels, or a credible consumer attribute to displace an incumbent.

How does CARE ONE Ibuprofen PM compare with Advil PM?

Factor	CARE ONE Ibuprofen PM	Advil PM
Active ingredients	Ibuprofen and diphenhydramine citrate	Ibuprofen and diphenhydramine citrate
Brand position	Private label	National brand
Typical price	Lower	Higher
Patent moat	Limited or none for basic combination	Mature product; any remaining rights would be product-specific
Distribution	Retailer-controlled	Broad branded distribution
Main advantage	Price and shelf placement	Brand recognition and marketing
Excipient differentiation	Usually limited	May vary by dosage form and manufacturer
Commercial vulnerability	Retailer switching and price pressure	Private-label substitution

The products can be therapeutically similar when they contain the same active ingredients and strengths, but inactive ingredients, tablet dimensions, coating systems, manufacturing sites, and packaging may differ.

Key Takeaways

• CARE ONE Ibuprofen PM is a mature OTC combination of ibuprofen 200 mg and diphenhydramine citrate 38 mg.
• The product’s commercial value is based on price, retailer distribution, manufacturing reliability, and packaging rather than broad patent exclusivity.
• The best excipient strategy is an immediate-release platform optimized for flow, compactability, rapid disintegration, dissolution, and coating durability.
• Direct-compression and simplified dry-granulation approaches offer the clearest cost-reduction potential.
• A smaller caplet, smoother coating, dye-free design, blister pack, or softgel could create commercial differentiation.
• Paragraph IV, biosimilar, and conventional Orange Book risks are not central to the basic OTC store-brand product.
• The largest competitive risks are retailer substitution, price compression, supply failures, and quality deviations.
• A scalable contract-manufacturing platform can support multiple retailer-specific pack sizes and presentations.

FAQs

Is CARE ONE Ibuprofen PM the same as Advil PM?

Both products are generally positioned around ibuprofen plus diphenhydramine as active ingredients, but their inactive ingredients, tablet design, manufacturer, packaging, and quality specifications can differ.

Can CARE ONE Ibuprofen PM be reformulated with fewer excipients?

Yes, a reduced-excipient formulation may be possible, but it must preserve tablet strength, disintegration, dissolution, stability, appearance, and regulatory compliance.

Is a liquid CARE ONE Ibuprofen PM product commercially attractive?

It could expand access for consumers who cannot swallow tablets, but solubility, taste, preservative, viscosity, and stability requirements would make it materially more complex and expensive than a caplet.

Can a new excipient combination receive patent protection?

Only a routine excipient substitution is unlikely to support strong patent protection. A patent case would require a novel composition or process with defensible claims and evidence of a non-obvious technical benefit.

What is the highest-value product extension?

A smaller, easy-to-swallow caplet in a blister or accessibility-focused package is likely to offer a better risk-adjusted opportunity than a complex liquid or modified-release product.

References

1. National Library of Medicine. (n.d.). DailyMed: CARE ONE Ibuprofen PM labeling. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/

2. U.S. Food and Drug Administration. (n.d.). OTC monograph M013: Internal analgesic, antipyretic, and antirheumatic drug products. https://www.accessdata.fda.gov/

3. U.S. Food and Drug Administration. (n.d.). OTC monograph M009: Nighttime sleep-aid drug products. https://www.accessdata.fda.gov/

4. U.S. Food and Drug Administration. (2020). Drug Facts labeling for nonprescription human drug products. https://www.fda.gov/drugs/understanding-over-counter-medicines/drug-facts-labeling-over-counter-otc-medicines

5. U.S. Food and Drug Administration. (2023). Current good manufacturing practice for finished pharmaceuticals, 21 C.F.R. Part 211. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211