McNeil Single-Active Children’s Cough/Cold OTCs Stress Simplicity, Safety
This article was originally published in The Tan Sheet
Executive Summary
Simply Stuffy and Simply Cough cold medicines - "from the makers of Children's Tylenol" - are designed to reduce consumer confusion and alleviate pediatricians' concerns about unnecessarily medicating children, McNeil Consumer & Specialty Pharmaceuticals maintained
|
Simply Stuffy and Simply Cough cold medicines - "from the makers of Children's Tylenol " - are designed to reduce consumer confusion and alleviate pediatricians' concerns about unnecessarily medicating children, McNeil Consumer & Specialty Pharmaceuticals maintained. In a departure from combination products, the new liquid remedies include only one active ingredient each: Simply Cough contains 5 mg dextromethorphan HBr and Simply Stuffy contains 15 mg pseudoephedrine HCl. Both actives are found in the same amounts in Children's Tylenol combination products. Simply Stuffy and Simply Sleep are the result of professional focus groups held by McNeil, during which pediatricians expressed interest in single-ingredient cough/cold products, McNeil explained. Parental confusion when selecting products in the cough/cold aisle also contributed to the products' development. Such confusion could cause parents to accidentally administer multiple acetaminophen-containing products to their children, potentially causing adverse events. FDA's Nonprescription Drugs Advisory Committee discussed several issues related to pediatric acetaminophen and potential medication, errors during the panel's review of OTC analgesics' safety Sept. 19-20 (1 (Also see "Acetaminophen Pediatric Concentrations Standardization Urged By NDAC" - Pink Sheet, 30 Sep, 2002.), p. 15). Prior to the meeting, McNeil announced plans to include "overdose warnings" on product labeling, as well as the statement "do not use with other medicines containing acetaminophen" on the principal display panel (2 (Also see "Voluntary Acetaminophen Labeling Revisions Include Overdose Warning" - Pink Sheet, 16 Sep, 2002.), p. 6). McNeil said the two new Simply products reflect a similar intent as the added warnings in that they are meant to help reduce potential product misuse. A statement on the products' PDP reads: "contains no fever reducer or pain reliever." Promotional materials note "acetaminophen...may be safely given as needed in addition to Simply Stuffy or Simply Cough." McNeil's ad agency of record for Tylenol, Saatchi & Saatchi (New York), is coordinating a "comprehensive support program for consumers and physicians." The firm plans to incorporate professional opinions in its Simply advertising to explain the value of treating just one symptom. TV ads, which broke Oct. 1, feature a mother waking up to the sounds of her daughter sniffling in another room. A voiceover says, "When your child's sick, the last thing you want to worry about is which medicine to choose." As the mother reaches for the product, the voiceover continues: "So when it's only a stuffy nose, reach for Simply Stuffy. The new single-ingredient medicine from the makers of Children's Tylenol that has only what you need." An FSI promoting most of McNeil and J&J/Merck's OTC lineup, including Simply Stuffy and Simply Cough, ran in Sept. 29 newspapers as part of McNeil's "Medicine Cabinet" campaign. Packaging for the new Simply products feature a blue background with pictures of mothers hugging young children. Both products carry the statement, "From the Makers of Children's Tylenol" above the Simply Cough or Stuffy brand names, as well as a seal stating "Only the Medicine Your Child Needs." The 3 Simply Cough Web site bears the claims: "Help your child feel better at the first sign of a stuffy nose by giving only the medicine your child needs. The only active ingredient in Simply Stuffy is a nasal decongestant that temporarily relieves stuffy noses due to colds, upper respiratory allergies, hay fever and sinusitis. It contains no fever reducer or pain reliever, and it's alcohol-free." The 4 oz. cherry-berry flavor liquids are indicated for children ages two through 11. The products, which shipped in July and are reaching full distribution nationwide, carry a suggested retail price of $4.97. Simply Cough and Simply Stuffy join Simply Sleep in McNeil's OTC family, although the firm said it is not trying to create a new brand identity. Simply Sleep caplets contain 25 mg diphenhydramine HCl and are indicated for individuals 12 and older. McNeil also circulated a coupon for Tylenol Cold and Tylenol Sinus Day & Night on Sept. 29. The combination packs - the first to be launched under the Tylenol brand - contain 12 pills each of the day and night formulas. "The separate blister packages of day and night caplets are easily distinguishable from each other," McNeil added. |