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OTC Products: Age Limits for Safe Use

While the FDA was scrutinizing nonprescription products to determine time limits for safe use (see last month’s “Consult Your Pharmacist”), the agency also was examining the need for age limits on OTC medications. The FDA determined minimum ages for safe use of many ingredients. Pharmacists can help ensure that these guidelines are followed.

FDA-approved age limits are clearly marked on the labels of most nonprescription products; however, various manufacturers have begun supplying their own pediatric dosing charts. The FDA has questioned the legality of these charts, and pharmacists need to be aware of how to use the dosing information provided (see “Manufacturer-Supplied Dosage Charts for Babies”).

However, even when an FDA-approved dosage recommendation is provided, the pharmacist may be confronted with an uncomfortable dilemma regarding dosing. For example, a parent or caregiver may wish to be advised of a safe dose of an antidiarrheal for a 14-month old or a proper dose of an antihistamine-containing cold preparation for a 4-year old. Labels on such products recommend consultation with a physician, but the parent/caregiver often approaches the pharmacist instead. Even with the best of intentions, the pharmacist who suggests a dose runs the risk of harming the child and incurring liability. For this reason, it is helpful to examine several products and their respective age cut-offs.

Rationales for Age Limits
The FDA recognizes that consumers need guidance in regard to safe ages for use of nonprescription products for several reasons. This article will categorize some of the reasons and provide examples to assist the pharmacist in performing patient triage (recommending an OTC product, referring the patient to a medical practitioner, or recommending against use of an OTC product). Some ingredients may have several reasons why their use is not recommended for patients below certain ages.

Unacceptable Risk: In some cases, patients below a certain age may experience adverse effects of a product or its active ingredient, and the effects would be too severe to warrant any potential benefit from use. For example, oral antihistamines generally are not labeled for use in patients under the age of 6 years. (The only exception is the FDA-approved use of dimenhydrinate in motion sickness.) The antihistamine precaution stems from a possibility of paradoxical stimulation, rather than the expected drowsiness, seen in patients younger than 6 years.1 Thus, anyone requesting a recommendation for a product to treat the common cold or allergic rhinitis should be questioned to determine the patient’s identity and age.

Another example of unacceptable risk in pediatric patients is with codeine. Schedule V codeine-containing cough preparations are sold without a prescription in some states, provided the pharmacist and patient comply with applicable state laws. During the FDA’s nonprescription drug review, several pediatricians stressed that codeine in children would be dangerous.2 The agency affirmed that children under the age of 6 are most vulnerable to codeine reactions, such as respiratory arrest, coma and death. For that reason, the final warning on codeine-containing products prohibits dosing in patients younger than 6 years old. If the product is administered to children under age 6 (presumably only with a physician’s approval), the FDA advises use of a special dosing device.

Inability to Use the Product Properly: In some cases, the FDA places an age limit on a nonprescription ingredient because a child may not be capable of properly using products that contain the ingredient. An example is fluoride-containing rinses, which are used topically to strengthen dental enamel, through correctly rinsing and expectorating. Unfortunately, children under the age of 6 years may not have full control of the swallowing reflex, and may accidentally swallow the rinse.3 If a child younger than 6 years ingests excessive fluoride, dental fluorosis resulting in dental staining is possible. If the city in which the child lives has a water supply that is fluoridated, the risk of dental fluorosis is magnified. Thus, current labeling on fluoride-containing dental rinses states, “Children under 6 years of age: consult a dentist or doctor.”4

Little Need for the Product: Some products are given an age limit because the FDA does not envision a situation in which children younger than that age would or should need it. One example is the use of syrup of ipecac. Syrup of ipecac is used for induction of emesis in accidental or intentional poisonings.

Although a dose is provided for patients as young as 6 months old, the FDA declined to extend dosing for children below that age. The agency stressed that the risk of accidental poisoning in children under the age of 6 months would be extremely rare because children are usually quite limited in voluntary mobility at those ages.5

Sunscreens are a somewhat different example of products that should not be necessary in young children. For several reasons, children under the age of 6 months should not be taken into the sun for periods long enough to warrant sunscreen use. The child cannot properly verbalize that his or her skin is becoming sunburnt, cannot voluntarily move to the shade, cannot sweat effectively, and has low dermal melanin content.6 Further, the skin of children under the age of 6 months may have different absorptive characteristics from the skin of older children and adults. Enhanced percutaneous absorption of sunscreen may occur.7 Thus, the FDA does not permit labeling of sunscreens for use in children younger than 6 months, and there is little need for them because parents or caregivers should completely avoid placing young babies in the sun.

Condition Reflects Serious Pathology: The pharmacist should be extremely wary in selling certain groups of products for use in young patients. The conditions for which the products are indicated would usually be trivial in an adult but would reflect serious pathology in a child. One example is the use of toothpastes containing potassium hydroxide for hypersensitive teeth. Hypersensitive dentinal enamel is a phenomenon caused by many contributing factors. The primary cause is recurrent microtrauma to the dental enamel caused by overzealous brushing or using a brush with unacceptably firm bristles. Either practice can thin dental enamel and open dentinal tubules, allowing the inner tooth pulp to register pain when confronted with heat, cold, sweets, air, or pressure. Dentinal thinning occurs after a fairly long period of enamel removal, making this etiology virtually nonexistent in childhood. If a child has hypersensitive dental enamel, it may be due to serious causes, such as a cracked tooth or filling, caries, or malocclusion (teeth do not align properly while chewing). Therefore, toothpastes for hypersensitive dental enamel are not permitted for use in patients under the age of 12 years unless recommended by a dentist or physician.8 The pharmacist should refer patients under the age of 12 complaining of dental hypersensitivity to a dentist to rule out any serious underlying cause for the problem.


For the last several decades, some manufacturers of nonprescription products have supplied dosage charts to pharmacists. The charts purport to provide safe dosages for babies as young as 0–3 months of age. Cough-cold remedies, acetaminophen, loperamide, and ibuprofen are some of the products whose manufacturers have formulated pediatric dosing recommendations. Pharmacists often assume that these charts are FDA-approved and that the dosages are appropriate for them to use for patient recommendations. However, these pediatric dosages were provided in FDA monographs as professional labeling, which is only to be used when relationship exists between the patient and another licensed prescriber (e.g., physician, dentist). The FDA has addressed this issue through the office of the Division of OTC Drug Evaluation.12 The agency stressed that pharmacists providing advice about professional uses of nonprescription products could be subject to civil liability. When a manufacturer alleges that the charts are FDA-approved, pharmacists should ask for a letter to the company from the FDA, specifically approving the dosage information. If such a letter cannot be provided, the pharmacist should realize the potential for patient harm and resulting civil liability before making recommendations.

A similar age problem arises with hemorrhoid treatments. Hemorrhoids may persist for many years without serious sequelae in adults. However, hemorrhoidal symptoms in children usually indicate a serious underlying condition, such as parasitic infestation, rectal prolapse, megacolon, or cystic fibrosis. When pediatric hemorrhoids are actually present, they are a result of serious conditions such as portal hypertension associated with liver disease, vena caval or mesenteric obstruction, or cirrhosis. The underlying condition must be promptly treated for the hemorrhoids to subside. For this reason, nonprescription hemorrhoidal products are contraindicated in patients under the age of 12 without a physician recommendation.9,10

Skin hyperpigmentation disorders are a final example of conditions that may reflect underlying pathology in pediatric patients. Skin lightening agents containing hydroquinone (e.g., Porcelana, Esoterica) are approved for use in ephelides (sun-induced freckles). However, pharmacists must question children or caregivers interested in using the products to ensure that the lesions to be treated are small, medium-brown macules scattered across the skin in areas of sun exposure. The macules should fade in the winter season. If the lesions do not reflect this pattern, the patient, regardless of age, should be referred. Patients under the age of 12 should obtain a physician recommendation for hydroquinone use.11 This allows the practitioner to confirm the existence of sun-freckles while ruling out other causes of skin discoloration (e.g., tinea versicolor or medication-induced pigmentation).

Highest and Lowest Age Limits
Teething Products: The lowest age limit specifically labeled by the FDA is for teething products (e.g., topical benzocaine). These products were assigned an age limit of 4 months; their use is not recommended in children under that age without a practitioner’s recommendation.6

Recent Rx-to-OTC Switches: Conversely, the highest age limits are mostly on recent Rx-to-OTC switches. Ketoprofen should not be recommended for patients under the age of 16 years. Minoxidil for hair loss is not indicated for patients 18 years of age and under. Similarly, nicotine patches and gum cannot legally be sold to anyone under age 18.6 If a patient under 18 years of age wishes to cease smoking, the pharmacist must refer him or her to a physician. The physician may either prescribe a smoking cessation product or provide a written recommendation for a nonprescription product. Pending further safety information, the FDA may also require any diet or cold product containing phenylpropanolamine to be labeled with a minimum age limit of 18 years. When in doubt, pharmacists should always read the label of nonprescription products to determine the minimum age for use. If no age recommendations are listed, the standard limit of 2 years applies (i.e., use is not recommended in patients under the age of 2 years).

Patient Information

Determining a Safe Dose: The common cold is one problem for which many people wish to treat children. However, if you read the labels on cold medications (such as nasal decongestants and most cough products), you will not find one to be used in children under age 2. Some (all products containing antihistamines) are not to be used in children under age 6. You may still wish to purchase these products, but there is no dose given on the label to guide you in giving a safe amount of the product to a young child. Some people might simply give a 1-year old child half the dose recommended for a 2-year old, but do not assume this is a safe thing to do.

Instead, call the child’s pediatrician or general practitioner to get a recommendation. The physician will then be aware that your child is taking the product in case there is a serious reaction to it later. Your physician also has knowledge of other factors that would affect safe use of the product, such as other medical conditions (heart problem, kidney disease). In addition, pediatricians often have a favorite product (along with dosage) they can recommend for such problems as nasal congestion and cough. Further, the pediatrician may wish to check for conditions that occur with or are mistaken for the common cold, such as strep throat, sinus infections, upper respiratory infections, or ear infections. The child can then be given a prescription for an appropriate treatment.

Knowing When to See a Doctor: Several conditions are more dangerous if they occur in a child compared to when they occur in an adult. In these cases, the child should see a physician. Diarrhea can become serious in children very rapidly because of loss of fluids and electrolytes. Any child under the age of 3 years who has diarrhea should be taken to a doctor.

Adults may treat the minor pain of arthritis, but arthritis in a child is potentially very serious and must not be treated without a physician consultation. Other types of pain in a child (e.g., headache, muscle aches) are also more serious than in an adult. Labeling on medications for these problems will warn not to use the product for more than 10 days in an adult but no more than 5 days in a child.

Insomnia in an adult is usually a short-term problem caused by adult worries, but insomnia in a child is a condition for which the caregiver should seek physician help. Nonprescription sleeping products are not to be used in patients under age 12. Sensitive teeth in children should not be treated with special toothpastes unless recommended by a dentist or physician. Children with hemorrhoid symptoms should see a doctor rather than use over-the-counter treatments. Young patients should also see a doctor before skin lightening agents (Esoterica, Porcelana) are used on sun-induced freckles.


OTC Products: Age Limits for Safe Use
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Before purchasing a nonprescription product, always examine the label closely. It is vital for you to know the minimum age for safe use. Many products have a clear age warning, such as, “Children under 6 years of age: consult a doctor.” These age limits appear on the product label because the product may harm children under that age.
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