Labeling for Bayer Women's Aspirin Plus Calcium "analgesic/dietary supplement" features both a "Drug Facts" box and "Supplement Facts" information.

The Drug Facts box highlights active ingredient 81 mg aspirin, while the separate Supplement Facts box notes the presence of 300 mg elemental calcium per tablet - approximately 30% of the mineral's recommended daily value.

As an example of how the dual "facts" box labeling can be duplicative and potentially confusing, the buffering agent calcium carbonate is listed as an inactive ingredient in the Drug Facts box; aspirin is the third component cited in the "ingredients" section below the Supplement Facts box.

Above the Supplement Facts box, directions state consumers should "take up to four caplets per day" for calcium. Drug Facts labeling advises that for temporary relief of pain, adults and children 12 and over should "take four caplets" while not exceeding "four caplets in 24 hours."

A side panel explains: "Adequate calcium intake throughout life, along with a healthy diet and regular exercise, builds and maintains good bone health and may reduce the risk of osteoporosis. While adequate calcium intake is important, daily intakes above 2,000 mg may not provide additional benefits."

Although packaging describes the product as a "low strength aspirin regimen" and an "analgesic/dietary supplement," labeling contains neither structure/ function claims nor the Dietary Supplement Health & Education Act disclaimer.

However, packaging states the product is "ideal for women on an aspirin regimen, as directed by a doctor, who need a head start on their daily calcium requirements to help fight osteoporosis."

The newest extension to the Bayer Aspirin line began shipping in November and is expected to reach national distribution in February.

Since 1986, Bayer has marketed Aspirin Regimen Bayer Adult Low Strength 81 mg with 100 mg elemental calcium as a buffering agent. However, product labeling does not make therapeutic claims for the mineral, stating only that each caplet "provides 10% of the daily value of calcium as part of the buffered base of calcium carbonate."

Dosing directions for Adult Low Strength differ from Bayer Women's Aspirin Plus Calcium, perhaps reflecting the latter's increased calcium level. Adult Low Strength labeling directs adults and children ages 12 and older to take "four or eight caplets with water every four hours, as needed, up to a maximum of 32 caplets per 24 hours or as directed by a doctor."

Bayer says the aspirin/calcium combination is an established combination under the internal analgesics tentative final monograph. Consequently, the product is unlikely to raise FDA's ire over the marketing of OTC analgesic/supplement combinations.

In October, the agency issued warning letters to Omni Nutraceuticals for two Inholtra Joint Pain products and to B.F. Ascher for its Melagesic PM Caplets (¹ Also see "OTC/Dietary Supplement Combos Cited In FDA Warning Letters" - Pink Sheet, 22 October, 2001., p. 3).

Each of the products combined acetaminophen with one or more of the supplement ingredients glucosamine, chondroitin and melatonin. However, FDA contended the presence of acetaminophen "renders the entire product a drug."

In a Nov. 6 response to FDA's warning letter, Omni pointed to Bayer Adult Low Strength 81 mg with calcium as a drug/supplement combination that has been sold for years without agency action, thus demonstrating the appropriateness of combination products (² Also see "Supplement/OTC Combos Have Precedents In Other Categories, Firms State" - Pink Sheet, 12 November, 2001., p. 8).

Bayer Women's Aspirin Plus Calcium, which is the only gender-specific offering in the Bayer Aspirin family, comes in 60- and 90-count SKUs with suggested retail prices of $6.99 and $9.99, respectively.

The new entry aimed at cardiovascular and bone health also marks a change for the analgesics category, in which OTCs targeted to women generally have focused on menstrual pain relief.

The launch of OTCs with both gender and age appeal mirrors the growing number of similarly niche-oriented dietary supplements, including Bayer's own One-A-Day Today multivitamin with soy, which debuted in October and is marketed "to support a healthy heart and bones for women 50 and over."

Although Bayer's NDA for Bayer Extra Strength Aspirin for Migraine Pain was approved by FDA in October, the company says it has not come to a decision about launching a migraine product.

Bayer Women’s Aspirin Plus Calcium Available Nationwide In February

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