Program on OTC Oral Pediatric Cough and Cold Medicines

Members of the Consumer Healthcare Products Association (CHPA) who make OTC oral pediatric cough and cold medicines are committed to enhancing the safe and effective use of these products by parents and other caregivers with children under their care.

Under a voluntary program which began in November 2007, with amendments in 2008, and formal adoption by the CHPA Board of Directors on November 18, 2008, manufacturers of OTC oral pediatric cough and cold medicines should take the following steps in the labeling, packaging, and promotion of these medicines:

A. Changes Within the “Drug Facts” Label

1. Label directions for children under age four, products without antihistamines. For OTC oral cough and cold medicines with labeling for use in children under 12 with nasal decongestants, cough suppressants, or expectorants, but without antihistamines, the FDA-required direction for “children under 2 years of age: ask a doctor” should instead direct that “children under 4 years of age: do not use” in the directions section of the label.
2. Label directions for children under age four, products with antihistamines. For OTC oral cough and cold medicines with labeling for use in children under 12 that include antihistamines under the relevant OTC Review monograph, the FDA-required direction to “ask a doctor” for children under 6 years of age should instead include the direction “do not use” for children under 4 years of age in the directions section of the label.
3. Cold products containing monograph antihistamines with labeling for children. OTC oral cough and cold products with labeling for use in children under 12 containing an antihistamine under the relevant OTC Review monograph should include a statement: “Do not use unless directed by a doctor” in place of the pre- existing direction to “ask a doctor” in children under 6 years of age in the directions section of the label.
4. Products containing monograph antihistamines with labeling for children. The warnings section of the label for all OTC oral medicines (whether for cough and cold, or allergy) with labeling for use in children under 12 containing an antihistamine under the relevant OTC Review monograph should include a warning: “Do not use to sedate children” or, alternatively, “Do not use to make a child sleepy”.

B. Additional Labeling Changes

1. Principal display panel. For OTC oral cough and cold medicines with labeling for use in children under 12, the principal display panel of products containing more than one active ingredient should include the name of all active ingredients, adjacent to the purposes.

2. Professional recommendation claims. While companies have a right to use truthful, not misleading claims where appropriately substantiated regarding recommendations by health professionals, the industry recognizes that “doctor recommended” claims for OTC oral cough and cold medicines have been questioned by regulatory officials and health professional organizations. Companies should stop use of “doctor recommended” and similar claims in labeling for OTC oral cough and cold medicines. Any reintroduction of similar terms after November 18, 2008, would be on the basis of robust support.

C. Packaging Changes

1. Dosing devices. Packaging of OTC oral cough and cold medicines in liquid form with labeling for use in children under 12 should include a dosing device appropriate to the product. Markings on such dosing devices should not include extraneous marking systems that do not correspond to a marking system on the label (i.e., “teaspoon” [tsp], or “ml”). Such dosing devices should include markings for amounts directed in the product’s labeling.

2. Child-resistant packaging. All OTC oral cough and cold medicines with labeling for use in children under 12 should come in child-resistant packaging.

D. Promotion Changes

1. Professional recommendation claims. While companies have a right to use truthful, not misleading claims where appropriately substantiated regarding recommendations by health professionals, the industry recognizes that “doctor recommended” claims for OTC oral cough and cold medicines have been questioned by regulatory officials and health professional organizations. Companies should stop use of “doctor recommended” and similar claims in advertising for OTC oral cough and cold medicines. Any reintroduction of similar terms would be on the basis of robust support.

E. Implementation

The implementation time for the labeling and promotion paragraphs of this program is at the next label printing, but no later than December 31, 2008.

The implementation time for the packaging change paragraphs of this program is no later than December 31, 2009.

OTC oral cough and cold medicines subject to a new drug application approved after the date of adoption of this program are exempt from section A of this program.