Witfire Elite | Philippines Pharma Watch | OTC Formulation Audit

Alevia-B is receiving fresh coverage in the Philippines through PascualLab’s 80th-anniversary portfolio campaign. Each tablet combines paracetamol with vitamins B1, B6 and B12. The Philippine FDA record, however, is dated 30 April 2025. The August 2026 coverage concerns a commercial campaign for an OTC product that was already registered.

Regulatory status OTC | FDA issuance 30 April 2025 | Current event August 2026 portfolio campaign

In its corporate release dated 26 August 2026, PascualLab said it was entering the mobility market with Alevia-B. Several Philippine lifestyle and entertainment websites published closely similar accounts over the following days.

That rollout may make Alevia-B look new in current headlines. The FDA database shows that the product was already registered as an OTC medicine, with its initial registration issued more than a year before the August 2026 campaign.

The timing shifts attention to the product’s commercial case. Does combining a familiar analgesic with high-dose neurotropic vitamins give PascualLab a distinct place in the market for everyday pain, mobility complaints and nerve-related symptoms?

01Alevia-B: what the Philippine FDA record confirms

30 April 2025initial OTC registration date | current registration runs to 30 April 2030

According to the official Philippine FDA product record, Alevia-B is a film-coated tablet registered as DR-XY49388. The entry classifies it as an over-the-counter analgesic, antipyretic and vitamin combination.

Registration numberInitial OTC application
DR-XY49388
Dosage formRegistered product form
Film-coated tablet
ManufacturerCountry of origin: Philippines
Lloyd Laboratories, Inc.
TraderFDA record
Ultramed Pharma, Inc.
DistributorFDA record
Pascual Consumer Healthcare Corp.
Registration window
30 Apr 2025 to 30 Apr 2030

The record confirms that Alevia-B may be marketed under its registered conditions. It provides no evidence that the finished combination works better than paracetamol alone. It also confirms that the August 2026 campaign was not a new FDA approval or registration event.

02What is in one Alevia-B tablet?

500 mg
Paracetamol
Analgesic and antipyretic component
50 mg
Thiamine mononitrate
Vitamin B1 component listed by FDA
100 mg
Pyridoxine hydrochloride
Vitamin B6 component listed by FDA
100 mcg
Cyanocobalamin
Vitamin B12 component

Paracetamol is the formula’s established analgesic and antipyretic component. Vitamins B1, B6 and B12 are involved in normal neural metabolism and function, which provides the biological rationale for including them.

That biological rationale still needs clinical evidence of an added benefit. The presence of four active ingredients alone cannot demonstrate faster action, relief across more types of pain or repair of damaged nerves.

Paracetamol provides the tablet’s direct analgesic action, while the B vitamins underpin its nerve-focused message. PascualLab uses the phrase “triple action” as marketing language rather than as the name of a measured clinical endpoint.

03Why PascualLab is combining pain relief with nerve support

Paracetamol is one of the most familiar medicines at the pharmacy counter. Its familiarity helps pharmacy recognition but gives individual brands little room to stand apart. Adding B1, B6 and B12 lets PascualLab link Alevia-B to a more specific group of complaints: muscle discomfort, joint discomfort, tingling and reduced mobility.

PascualLab’s commercial case for the formulation rests on three specific points. It puts all four ingredients in one tablet, extends the brand into the broader mobility category and connects common aches with symptoms that consumers may understand as nerve-related.

At the pharmacy counter, people often describe pain broadly rather than classify it by cause. They may not know whether an ache is musculoskeletal, neuropathic or mixed. That uncertainty limits the claim: tingling has several possible causes and should not automatically be treated as a symptom that will respond to vitamins.

Witfire’s Lumvoa launch analysis covered a different therapeutic area but examined the same divide between regulatory entry and commercial differentiation. Alevia-B has established regulatory status. PascualLab still needs to explain why consumers should choose this combination while keeping its nerve-related language within the available evidence.

04What the clinical evidence actually shows

In our search, we did not find a public randomized trial comparing the finished Alevia-B tablet with paracetamol alone. The absence of such a trial cannot be used as evidence that the product is ineffective. The evidence boundary is clear: no public study has demonstrated an advantage over plain paracetamol.

The closest related evidence comes from a small randomized, double-blind study in Indonesia, although it did not test Alevia-B. Researchers enrolled 117 people with acute non-neuropathic pain and analysed 114 after three exclusions. Both groups received paracetamol 500 mg three times daily for three days. The test group also received B1 100 mg, B6 100 mg and B12 5,000 mcg once daily. After adjustment, the reduction in pain favored the vitamin group by 10.84 mm on a 100-mm scale (95% CI 1.02 to 20.66; p=0.031).

Several design and formulation differences limit how directly those results apply to Alevia-B. The study lasted only three days, was conducted at one centre and included a clinically mixed group of patients. It did not examine neuropathic pain. The B1 and B12 doses also differ substantially from Alevia-B, while the vitamins were administered separately once a day rather than in the registered Philippine tablet. The findings support testing the finished formulation directly.

Studies using other analgesics cannot answer the specific Alevia-B comparison. A meta-analysis reported that diclofenac combined with B1, B6 and B12 may shorten treatment for acute low-back pain. Because diclofenac is a different analgesic, the result cannot be transferred directly to a paracetamol combination; the authors also found insufficient evidence for other types of pain.

Evidence for peripheral neuropathy is also limited. PascualLab cites a Cochrane review covering 13 trials and 741 participants. That review concluded that the randomized evidence was insufficient to determine whether vitamin B was beneficial or harmful for peripheral neuropathy.

Normal nerve metabolism is a biological role; treating neuropathic pain requires direct clinical evidence.

Alevia-B has a plausible biological rationale, while the available clinical studies mostly use other formulations or provide only indirect support. No public study currently shows that this exact tablet provides better relief than paracetamol alone for nerve-related pain.

05The dosing instructions and safety questions

On its official product page, PascualLab tells adults, older people and those over 14 years to take one tablet one to three times daily, after meals and for the shortest possible duration. The next line says the tablet should be taken every four to six hours. Read together, those instructions are unclear, and PascualLab should explain how they fit together.

At the stated maximum of three tablets a day, Alevia-B provides 1,500 mg paracetamol, 150 mg thiamine mononitrate, 300 mg pyridoxine hydrochloride and 300 mcg cyanocobalamin.

Paracetamol boundaryThe PascualLab page states a 4,000 mg total-daily ceiling across all paracetamol-containing medicines. It is not permission to take eight Alevia-B tablets. The same page separately directs one tablet one to three times daily.

The most immediate paracetamol risk is accidental duplication. Cold, flu, headache and prescription medicines may contain the same ingredient under different product names. The U.S. FDA advises people not to take more than one acetaminophen-containing product at the same time, because excessive exposure can cause severe liver injury. Consumers should follow the Philippine label and check every medicine they are taking for paracetamol.

Pyridoxine raises a separate safety question. Each tablet is registered as containing 100 mg pyridoxine hydrochloride. Australia’s medicines regulator warns that vitamin B6-associated peripheral neuropathy may present as tingling, burning or numbness. It has received reports at stated vitamin B6 exposures below 50 mg daily and notes that people may unknowingly combine B6 from several products.

The numbers require care before comparison. The Alevia-B record reports milligrams of pyridoxine hydrochloride, whereas the Australian notice refers to milligrams of vitamin B6. The warning remains relevant to the safety discussion, although a direct numerical comparison requires a documented conversion because the two figures are not chemically interchangeable.

The Australian warning does not set a Philippine regulatory standard or show that Alevia-B breaches Philippine requirements. It remains clinically relevant because tingling, burning and numbness may be described as nerve-related pain and are also reported with excessive B6 exposure. Pharmacy counselling should therefore cover duration of use, total B6 intake and concurrent use of multivitamin or magnesium products.

Evidence boundaryWe found no public evidence that a short course of Alevia-B causes neuropathy. The concern is more specific: a tablet containing 100 mg pyridoxine hydrochloride should not be treated as an ordinary low-dose daily vitamin.

06How Alevia-B fits into PascualLab’s portfolio

PascualLab has made Alevia-B central to its move into the mobility market, promoting it through the company’s 80th-anniversary portfolio update. The campaign links the tablet to pain and mobility rather than only the familiar fever-and-ache category. It is aimed at adults who connect limited movement with muscle, joint or nerve-related symptoms.

On 1 September, we counted at least a dozen current pages carrying the announcement or a close rewrite. Their sequence, wording and repeated “mobility market” language lead back to the same PascualLab corporate release. The count reflects how widely the campaign was distributed online. Most of those pages draw on the same source rather than providing twelve independent pharmaceutical reviews.

PascualLab’s commercial case for Alevia-B rests on four points:

  • Access
    Its OTC classification makes the product available through consumer-facing pharmacy channels.
  • Convenience
    A single tablet combines paracetamol with three B vitamins.
  • Positioning
    The mobility theme moves the brand beyond general pain relief.
  • Local chain
    Philippine manufacture and distribution place the product within PascualLab’s domestic consumer-health portfolio.

A convenient format may improve access; efficacy still requires separate evidence. Witfire’s oral Wegovy market analysis examined that issue in a different therapeutic category. In the Philippines, the immediate questions for Alevia-B are label clarity, pharmacy counselling, price, availability and real-world use of combination OTC medicines.

The corporate release gives no price or comparative uptake data, so claims of market disruption would be premature. The formulation gives Alevia-B a recognizable way to stand apart from plain paracetamol products. Whether that difference leads to repeat purchases remains unknown.

07What the Alevia-B campaign leaves unanswered

  • Approval
    The August 2026 campaign is not tied to a new FDA authorization. The record was issued on 30 April 2025.
  • Superiority
    No public brand-specific head-to-head trial has shown that Alevia-B works better than paracetamol alone.
  • Neuropathy
    The nerve-support message does not establish treatment for every cause of tingling, numbness or neuropathic pain.
  • Long use
    The public page says treatment should be as short as possible. It provides no basis for routine long-term daily use.
  • Consensus
    The cluster of near-identical articles shows how widely the campaign was republished; those articles do not provide independent clinical validation.

The public record verifies the formula and OTC status. It contains no direct comparison showing whether the registered tablet relieves the campaign’s target symptoms better than paracetamol alone.

08Witfire Risk Score

This score measures public-evidence and use uncertainty around Alevia-B using information available through 1 September 2026. A higher number means greater uncertainty. It is not an estimate of an individual patient’s chance of harm or a finding that the product is unsafe.

Alevia-B | evidence and use risk
7.1 / 10 | Elevated
Finished-product Evidence | 30%
8.5
In our search, we found no public randomized trial comparing the registered Alevia-B tablet with paracetamol alone. The closest trial used different vitamin doses, a separate regimen and an acute non-neuropathic pain population.
Exposure and Counselling | 25%
6.5
Pharmacy counselling should cover duplicate paracetamol and cumulative B6 exposure. We found no public evidence that a short course of Alevia-B causes neuropathy.
Dosing Clarity | 20%
8.0
The public product page gives one-to-three-times-daily and every-four-to-six-hours statements without explaining how the two directions fit together.
Claim-Evidence Fit | 15%
7.5
The nerve-related and “triple action” positioning is broader than the direct evidence available for this exact tablet. It does not establish treatment across neuropathy causes.
Regulatory Uncertainty | 10%
2.0
Low. The Philippine FDA record lists an active OTC registration from 30 April 2025 to 30 April 2030. The current publicity is a commercial campaign, not a new authorization.
Weighted calculation
(8.5 x 30%) + (6.5 x 25%) + (8.0 x 20%) + (7.5 x 15%) + (2.0 x 10%)
Composite risk score = 7.1 / 10 | Elevated

The active OTC registration keeps regulatory uncertainty low. The overall score is driven by the absence of a comparison using the finished tablet, unreconciled public dosing directions and the counselling burden around duplicate paracetamol and cumulative B6 exposure.

09Verdict on Alevia-B’s place in the pain portfolio

Regulatory positionPhilippine FDA record
Registered OTC
Current news26 to 31 August 2026 coverage
Portfolio campaign
Finished-product superiorityPublic head-to-head evidence found
Not established
Key scrutiny pointPer tablet
Pyridoxine HCl 100 mg
Witfire view
Clear market position; product-specific evidence limited

With Alevia-B, PascualLab has a simple entry into the pain and mobility category. Paracetamol is already familiar to consumers; the B-vitamin rationale is easy to follow, and OTC status supports pharmacy access.

PascualLab’s commercial case is clear, while public evidence for the finished product’s added benefit remains limited. Its registration was issued in April 2025, well before this campaign. Available evidence still does not show that adding B vitamins allows the tablet to treat neuropathy broadly.

To strengthen the case, PascualLab would need clearer public dosing directions and a direct comparison using the registered formulation, together with more prominent counselling on duplicate paracetamol and cumulative B6 exposure.

10Alevia-B FAQs

What is Alevia-B?

Alevia-B is an over-the-counter film-coated tablet that combines paracetamol with vitamins B1, B6 and B12. PascualLab markets it for mild-to-moderate muscle, joint and nerve-related pain, with the B vitamins positioned as support for normal nerve function.

What is the Alevia-B composition?

According to the Philippine FDA record, each tablet contains paracetamol 500 mg, thiamine mononitrate 50 mg, pyridoxine hydrochloride 100 mg and cyanocobalamin 100 mcg.

Is Alevia-B newly approved in the Philippines?

No. Its initial FDA registration was issued on 30 April 2025. The August 2026 coverage relates to PascualLab’s commercial and portfolio campaign, not a first regulatory authorization.

Is Alevia-B an OTC medicine in the Philippines?

Yes. The Philippine FDA classifies Alevia-B as an over-the-counter medicine. Consumers still need to follow the label, avoid taking another paracetamol-containing product at the same time and keep treatment as short as directed.

Is Alevia-B proven to treat nerve pain?

PascualLab positions the product for mild-to-moderate nerve-related pain. Public evidence does not show that this exact tablet is superior to paracetamol alone or that it treats every form of neuropathy.

How should Alevia-B be taken?

PascualLab’s public page instructs people over 14 to take one tablet one to three times daily, after meals and for the shortest possible duration. The same page also includes an every-four-to-six-hour statement. Consumers should follow the approved pack label or ask a pharmacist to clarify the directions rather than trying to reconcile the two statements themselves.

Who makes and distributes Alevia-B in the Philippines?

The Philippine FDA record names Lloyd Laboratories, Inc. as the manufacturer, Ultramed Pharma, Inc. as the trader and Pascual Consumer Healthcare Corp. as the distributor.

Witfire Elite Pharma News | PascualLab began its current commercial campaign in August 2026; the Philippine FDA registration for Alevia-B dates to April 2025. Claims made by PascualLab are attributed to the company and evaluated separately from independent clinical evidence.
Primary and regulatory sources: Philippine FDA product record DR-XY49388. PascualLab Alevia-B product page. PascualLab 80th-anniversary portfolio release, 26 August 2026.

Scientific and safety sources: Ang CD et al. Vitamin B for treating peripheral neuropathy. Cochrane Database Syst Rev. 2008;CD004573. Ariady R et al. Comparison of paracetamol with paracetamol plus vitamin B for acute non-neuropathic pain. Berkala Neurosains. 2020;19(2):69-75. Calderon-Ospina CA et al. Diclofenac plus B vitamins for low-back pain. Pain Med. 2020;21(4):766-781. U.S. FDA, Acetaminophen safety. Australian TGA, vitamin B6 and peripheral neuropathy safety update.

Computed in this brief: At the public website maximum of three tablets daily, the listed ingredients total paracetamol 1,500 mg, thiamine mononitrate 150 mg, pyridoxine hydrochloride 300 mg and cyanocobalamin 300 mcg. These totals are arithmetic, not a dosing recommendation.

Risk model: The 7.1 score uses an Alevia-specific editorial model: finished-product evidence 30%, exposure and counselling 25%, dosing clarity 20%, claim-evidence fit 15% and regulatory uncertainty 10%. It measures public-evidence and use uncertainty, not patient-harm probability, and is not intended for cross-product clinical comparison.

Known public gaps: A public brand-specific randomized comparison against paracetamol alone, Philippine retail pricing and uptake, a reconciled public explanation of the one-to-three-times-daily and every-four-to-six-hours directions, and longer-term safety evidence for use of the registered combination.

Disclosure: Editorial analysis, not medical advice. Readers should use the medicine only as directed on the approved pack and consult a pharmacist or physician when symptoms persist, when other paracetamol or B6 products are used, or when tingling, burning or numbness continues or worsens.
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