To comply with evolving FDA regulation and promote public health, manufacturers of OTC medicines must follow standardized label rules designed for accessibility and accuracy. This guide breaks down essential OTC labeling requirements and provides insights for achieving Over-the-counter compliance across diverse product types and container formats.
American consumers often rely on medications they obtain from their local pharmacies for a multitude of situations. From the common cold to the chronic condition, these drugs can provide symptomatic relief and facilitate healing. But that's only true if these medications are properly protected and taken correctly. Shockingly, nearly 40% of prescriptions issued will not be taken as directed -- but what about the medications that don't even require a prescription? Over-the-counter (OTC)r pharmaceutical labeling is just as important as product labeling for pharmaceuticals that are dispensed via prescription.
In addition to tamper evident packaging and other packaging safeguards that prevent contamination, labeling plays an essential role in product identification and instructions for use. To ensure compliance and consumer safety, here are the essential regulations for over-the-counter drug labeling businesses should know and follow.
In 1999, the FDA published an overhaul of their information pertaining to over-the-counter drug labeling. This change affects more than 100,000 OTC drug products and involves an overall simplification of language used in these kindOver-The-Counter (OTC) Pharmaceutical Labeling
Why the FDA Updated OTC Labeling Rules
Previously, FDA research found that consumers encountered difficulty with label readability; this was a particular problem for many older Americans, who purchase nearly 30% of all over-the-counter medications sold throughout the nation. Certain words used in older types of OTC labeling -- such as "precautions," "indications," and "contraindications" -- were extremely confusing. What's more, it was difficult to find information about approved used, warnings, directions, and inactive ingredients, as they could all be found in different areas on a label and were not made obvious to the consumer.
Therefore, the new FDA regulations introduced a drug facts label template that mimics the style of nutritional facts labeling on food and beverages. This prioritizes language and formatting that's easy to read and understand, allowing consumers to more accurately follow directions and compare available medications prior to making a purchase.
Manufacturers are required to adhere to specific regulations in terms of format and style to ensure that their custom Over-the-Counter (OTC) labels can be clearly understood by the average consumer. In short, confusing labels need not apply. If you are manufacturing an over-the-counter drug product, your labeling must be straightforward and simple enough to meet FDA requirements.
The FDA also mandates that specific information be included in a specific order on custom pharmaceutical and OTC labels. To meet FDA labeling requirements for OTC drugs, these labels must include:
| Label Category | Description |
| Title | "Drug Facts" or "Drug Facts (Continued)" heading to begin the information panel |
| Active Ingredient(s) | Name and amount of each active ingredient per unit |
| Purpose | The product's general function (e.g., pain reliever, antihistamine) |
| Use(s) | Symptoms or conditions the product treats or prevents |
| Warnings | When not to use the product, possible side effects, and when to consult a doctor |
| Directions | Dosage information and instructions for proper use |
| Other Information | Storage details or handling instructions |
| Inactive Ingredient(s) | Ingredients that don’t affect the therapeutic action but are part of the formula |
| Questions or Comments | Manufacturer contact information for consumer support |
What's more, information like expiration dates, lot and batch codes, net quantity, and instructions for emergency situations will also need to be included. Each of these informational categories may be relatively detailed, which can present a challenge for manufacturers who need to create custom pharmaceutical labels on relatively small bottles or packages of OTC medications.
New label technology developed over the last several years allows label manufacturers to incorporate multiple pages into label designs, thereby allowing drug manufacturers to meet FDA labeling requirements by giving them enough room to put all the information in a legible format. Manufacturers to meet these demands through expanded content label types such as pressure-sensitive labels or peel-back constructions that accommodate full content without crowding. These are particularly helpful for small/compact bottles or OTC healthcare packaging where space is a limiting factor.
In addition to these labeling elements, manufacturers must complete drug establishment registration and OTC drug establishment registration to remain compliant with FDA tracking and accountability requirements.
It's therefore recommended that manufacturers work with label companies that are extremely familiar with requirements put forth by relevant governing agencies to comply with OTC labeling requirements
OTC drug labels also need to feature a certain formatting style. Manufacturers must follow FDA guidelines pertaining to type size and font characteristics, heading alignment and punctuation, bullet usage, divider lines, panels, and graphics.
At a minimum, the type size must be equal to or exceed 6.0 point font to ensure legibility for the 60+ consumer and to account for all the information that must be included on packaging and labeling. The font size does not need to be increased when packaging size increases, but the font size cannot be reduced below the threshold even when packaging sizes are excessively small.
Because they offer 360° branding, Shrink sleeves may also be used in conjunction with functional labels to allow brands to maintain high-impact design while achieving regulatory compliance. This approach enables flexibility for brands that rely on standout visuals as part of their packaging strategy.
The FDA does not typically grant exemptions to manufacturers to claim that their products are too small for fulfill the agency's requirements; there can be modifications made to ensure all label elements are included. Again, it's best to work with an experienced labeling company to make certain your custom pharmaceutical labels are formatted correctly and that they contain all necessary information while promoting your product in the best way possible.
Over-the-counter medications are a necessity in countless American households, which means manufacturers must be held accountable for promoting consumer safety. By keeping these labeling requirements in mind and working with a reliable label manufacturer for pharmaceuticals, your product can safely be chosen and used by people all over the country.
Even with clear guidelines in place, many manufacturers fall short of meeting OTC drug labeling standards due to the following common pitfalls:
Avoiding these errors not only reduces the risk of recalls but also supports long-term consumer trust in your OTC product.
Proper OTC drug packaging is more than a formality – it’s a safeguard for consumer health and brand reliability. Effective labelsprotects users, satisfies FDA requirements, and reinforces the product’s credibility in a crowded marketplace.
By prioritizing clarity, compliance, and design, you support both consumer well-being and brand integrity.
Partnering with a team experienced in FDA labeling format, over-the-counter compliance, and diverse packaging formats – from shrink sleeves to expanded content label types – can help your next OTC product succeed on every shelf.
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