Over-The-Counter (OTC) Medicaments

OTC or over-the-counter drugs, also known as non-prescription drugs, are marketed with a view to put off, treat as well as cure diseases, wounds or severe or chronic medical condition or provide symptomatic respite from them. These medications are made available to enable you to identify as well as treat these conditions by yourself or with advice from professional medical practitioners. In other words, these medicines are sold legally, but without a valid prescription from a physician.

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However, the manufacturer of an over-the-counter medicament is not entitled to claim that it can be used for treating acute diseases or severe conditions that necessitate frequent attention as well as observation of a certified medical practitioner. Hence, legally, non-prescription or over-the-counter drugs may be defined as those that can be used safely even without any medical supervision and do not pose any risks to our health.

Precisely speaking, compared to prescription drugs, we normally use over-the-counter medications as much as four times more to treat ordinary health issues by ourselves rather than visiting a physician to get the conditions treated. According to available data, about 60 per cent of medications that we keep at our homes are actually non-prescription drugs.

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As mentioned earlier, you do not require a physician's prescription to purchase over-the-counter drugs. A number of OTC medications available in the market are used to ease pains, aches and itches. In addition, some non-prescription drugs are effective for prevention as well as treatment of ailments, such as athlete's foot and tooth decay. There are other OTC medications that aid in dealing with chronic health problems, such as migraines.

In the case of the United States, the responsibility of deciding whether a medication is sufficiently safe for being sold over-the-counter lies with the Food and Drug Administration (FDA). All said and done, using non-prescription drugs still involves some amount of risks. While a number of over-the-counter medications interact with other medications, dietary supplements, foods or beverages, there are others that result in problems in people suffering from specific health condition. Women who are pregnant should consult their physician prior to using any non-prescription medication.

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In addition, proper caution needs to be exercised to ensure that these medications are taken properly and also while administering over-the-counter medications to children. It is important to remember that using more of a medication does not necessarily mean that it will produce better results. Over-the-counter medications should never be taken in elevated doses or for prolonged periods than what have been instructed on the label of the product. In case, you are not relieved even after using non-prescription medicines, it means that you should essentially consult your physician for proper treatment of your health condition.

Some of the common ailments that are generally treated with over-the-counter medications instead of visiting a professional medical practitioner include:

Using non-prescription medicines to treat minor health problems by yourself is much inexpensive compared to visiting a physician, who will prescribe medications after examining the health problem you may be suffering from. You can also save much by opting for generic drugs instead of branded medicines and also by going for house brands or over-the-counter medications that are not advertised. The FDA makes it mandatory for pharmaceutical manufacturing over-the-counter medications of a specific category to follow particular recipes. For instance, several medicines having different names and meant for curing coughs are likely to enclose just the same elements. You can verify this by checking the composition of different products mentioned in their labels and in case proportion of ingredients used in these products is identical or somewhat same, you may choose the product that is less expensive. However, you may find that one particular compound may have a better flavour or appearance compared to another. In such instances you ought to remember that the implementation of the standards set by the FDA are sometimes inconsistent. Hence, it is very likely that at times you will opt for a brand name medication rather than a product marketed by a not so familiar manufacturer.

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Over-The-Counter (OTC) medicament safety

The Food and Drug Administration (FDA), in 1972, started the process of reassessing the constituents of roughly 300,000 over-the-counter medicines marketed in the United States.

In August 1992, the FDA recommended that as many 415 ingredients contained in seven different categories of prescription drugs are banned. It stated that contrary to the claims, researches did not show that their use was safe or effective. In related actions, in November 1990, the FDA also prohibited the use of 223 ingredients from 19 different categories of medical products as they were found to be ineffective. It also banned the use of 111 other ineffective ingredients used in weight control medications in August 1991.

Nearly all the ingredients that were identified and banned by the FDA have already been discontinued. Nevertheless, many products having one or a few of these banned ingredients are still being sold in the market. As a result, it is becoming necessary for the manufacturers of these medicines to either remove them from the market or reformulate their products.

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However, the ban on a number of constituents is not absolute. While an ingredient may be banned for use in one medicament, it may be used in another medicament. For instance, although the use of salicylic acid is prohibited in medications used in the form of a pain reliever used topically to treat insect bites and stings, it is effective for getting rid of corns, warts and calluses. In a number of instances, ingredients that are considered to be safe for use, but are not permitted for use as per specific claims regarding them, these elements may still be employed in the form of inactive elements. For instance, although peppermint is not a very effectual digestive aid, it may still be used in the form of a flavouring agent.

In addition, some over-the-counter monographs - recipes or standards - also exist in the market that record the elements whose use are permissible, the legitimate claims as well as the requisites for labelling. Majority of the non-prescription medicaments are prepared following the monographs and in this case the manufacturers are not required to apply for testing before marketing their products. Nevertheless, if a manufacturer submits an application requesting the approval of an 'original' or new over-the-counter product for which there is no existing monograph, the manufacturer requires filing a New Medicament Application. This process is very much similar to obtaining an approval for a new or patented prescription drug and the process involved in obtaining the approval may take a long time.

Sometimes, it may not be necessary for the manufacturer to provide the FDA with additional information regarding the over-the-counter products available on the market. For instance, when it was found that children using aspirin may be susceptible to viral infections and Reye's syndrome, a brain ailment that may prove to be fatal, the over-the-counter labelling for aspirin was revised.

The FDA also allows preparation and marketing of new drug combinations. Sometimes, adjustments are also made. Even the monographs are revised too. Generally, the FDA does not initiate any prosecution action against the over-the-counter medicaments that are already being sold, as long as the manufacturer abides by the rules and does not overstate or make tall claims regarding the benefits of the medicaments to the people in general.

However, this does not suggest that medications sold without any doctor's prescription do not have the potential to produce hazardous side effects.

It is mandatory for medicaments sold over the counter to be accompanied by precautionary notes on specific products. For instance, phenylpropanolamine (also known as PPA) is a very common constituent in dietary aids. This ingredient has the potential to bring about very fast heartbeat and also result in high blood pressure (hypertension), a major anxiety for individuals who are already susceptible to high blood pressure. In severe instances, the stimulants present in this medicine have the ability to cause the heart to beat dangerously fast and also lead to irregular heartbeats.

It has been found that antacids, which help in digesting ingested foods, have the aptitude to get in the way our body assimilates other substances. Excessive use of antacids may possibly result in digestive problems, mainly constipation or diarrhea. In addition, people suffering from hypertension (high blood pressure) or those having a history of heart failure should not take sodium bicarbonate, as it encloses plenty of salt.

Researches undertaken in recent times have demonstrated that using the non-prescription medication ibuprofen as well as the palliative drug acetaminophen may cause additional harm to people who have been suffering from moderate kidney ailment from before. It is important to note that even inappropriate use of vitamins may prove to be detrimental for your health.

The Food and Drug Administration aims to make it mandatory for the manufacturers to mention the sodium content contained in a medicament on its label and ensure that the information is printed in the best possible size as well as style to enable the purchasers read it easily.

Meanwhile, medical professionals and consumer advocates are strongly debating the safety issues regarding the extent to which we are able to go to diagnose as well as treat our ailments all by ourselves. For instance, when the remedies meant for vaginal infections by yeasts changed from Rx to over-the-counter, a number of people raised questions regarding the appropriateness of self-diagnosis. However, the advisory board of the Food and Drug Administration had ruled that the symptoms of vaginal yeast infection are so explicit that when a physician diagnoses and treats any woman of this condition, she does not require going back to the physician in case the symptoms occur again.

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