580:
customer asks for a remedy, e.g., hay fever, then the '2WHAM questions' must be asked "Who is it for?", "What are the symptoms?", "How long have you had the symptoms?", "Have you taken any action towards your symptoms?", and "Are you taking any other medication?". It is with this information that the pharmacist can halt the sale, if need be. No , or products that are stocked in a pharmacy can be sold, dispensed, or pre-made until a responsible pharmacist is signed in and on the premises. Some medication available in supermarkets and petrol stations is sold only in smaller packet sizes. Often, larger packs will be marked as and available only from a pharmacy. Frequently, customers buying larger-than-usual doses of medicines (such as
298:(GRAS/E). To deal with the vast number of OTC drugs that were already on the market before the requirement that all drugs obtain an NDA, the FDA created the OTC monograph system to review classes of drugs and to categorize them as GRAS/E after review by expert panels. Certain classes of OTC drugs would not be required to obtain an NDA and could remain on the market if they conformed to the monograph guidelines for doses, labeling, and warnings finalized in the
547:
reserved from the GSL list as they are either associated with a need for advice on use, or used in conditions which may require referral to a medical prescriber. Suitably trained counter assistants may sell a 'P' medication under the supervision of a pharmacist and will ask questions to determine if the customer needs to be referred for a discussion with a pharmacist. Some 'POM' medicines are available for use in certain situations and doses as 'P' medicines.
439:
1837:
1666:
1626:
1338:
1299:
373:(CARES Act) includes reforms that modernize the way certain OTC drugs are regulated in the United States. Many OTC monographs need to be updated but updating or changing an OTC monograph requires the slow and burdensome notice-and-comment rulemaking process. The CARES Act includes OTC monograph reform provisions that replace the rulemaking process with an administrative order process.
40:
60:
246:. A drug that is UAD can also be sold at drugstores which are stores where no prescription can be filled. The drugs are usually on the shelves, and the store also sells items like toys, gadgets, perfumes and homeopathic products. The drugs in this category have limited risk and addiction potential. Examples are
546:
Pharmacy
Medicines (P) are medicines that are legally neither a POM or GSL medication. These can be sold from a registered pharmacy but should not be available for self-selection (although directions to discuss a 'P' product may be allocated shelf space with associated GSL items). 'P' medications are
191:
All medications other than
Schedule 1 may be considered an OTC drug, as they do not require prescriptions for sale. While the National Association of Pharmacy Regulatory Authorities provides recommendations on the scheduling of drugs for sale in Canada, each province may determine its own scheduling.
200:
In
November 2016, India's Drug Consultative Committee announced it was embarking on establishing a definition of drugs which could be dispensed without a prescription. Prior to this, the general assumption was that any drug which did not fall into a prescription schedule could be purchased without a
596:
As a general rule, over-the-counter drugs have to be used primarily to treat a condition that does not require the direct supervision of a doctor and must be proven to be reasonably safe and well tolerated. OTC drugs are usually also required to have little or no abuse potential, although in some
154:
As of 2011, around a third of older adults in the U.S. reportedly used OTC drugs, and this number is increasing. By 2018, the prevalence of use by adults in the U.S. as first-line treatment for minor illnesses had reached 81%: however, there is some debate as to whether this figure relates to an
381:
An ill-defined third category of substances is products having over-the-counter status from the FDA while being simultaneously subject to other restrictions on sale. While they are legally classified as OTC drugs, they are typically stored behind the counter and are sold only in stores that are
579:
codes to ask certain questions, which varies for what the customer says. If they ask for a specific product, the pharmacy assistant must ask "Who is it for?", "How long have you had the symptoms?", "Are you allergic to any medication?", "Are you taking any medication?" ('WHAM' questions). If a
506:
General Sales List (GSL), available off the shelf with no pharmacy training required to sell (so they can be sold anywhere, such as supermarkets). In general, they are considered safe for most people when taken correctly. Examples of these include 16-packs (or less) of painkillers such as
551:
If it is not appropriate to sell a 'P' medication – i.e. the condition is not suitable for self-management and requires referral to a medical prescriber – then a sale should not occur and the pharmacist has a legal and professional obligation to refer this on to an appropriate service.
351:
The FDA requires OTC products to be labeled with an approved "Drug Facts" label to educate consumers about their medications. The labels comply to a standard format and are intended to be easy for typical consumers to understand. Drug Facts labels include information on the product's
183:
Schedule 3: Does not require a prescription but must be kept in an area under the supervision of a pharmacist. These drugs are kept in an area of the retail outlet where self-selection is possible, but a pharmacist must be available to assist in the self-selection of medication if
631:
in young women. A study has been done examining consumer's perceptions about the risk of and access to nonprescription medication. The study concluded that a small percentage of consumers prefer having access to medication over potential risks of taking non-prescribed medication.
478:
has to be on the premises for POM medicines to be dispensed, required by law. The medicine has been specifically prescribed for the patient holding the prescription, so it is considered safe for only the recipient to take. Just a small example of these include most
409:. After initial attempts to control methamphetamine use (by requiring documentation of sale with government issued ID as well as limits on the quantity an individual could purchase) failed to realize meaningful reductions in methamphetamine use and production,
137:
require a prescription from a doctor or other health care professional and should only be used by the prescribed individual. Some drugs may be legally classified as over-the-counter (i.e. no prescription is required), but may only be dispensed by a
179:
Schedule 2: Does not require a prescription but requires an assessment by a pharmacist prior to sale. These drugs are kept in an area of the pharmacy where there is no public access and may also be referred to as "behind-the-counter"
575:. Medication available only with a prescription is marked somewhere on the box/container with . Pharmacy-only products are marked with . A prescription is not required for medicines, and pharmacy sales assistants are required by
457:
controlled substances may be classified as OTC products in certain states. Such drugs are sold without a prescription but are subject to record-keeping rules and quantity and/or age restrictions, and they must be dispensed by a
1425:
1806:
1611:
308:
or (2) pursuant to an NDA for products that do not fit within a specific monograph. There is also the possibility that certain OTC drug products are marketed under the grandfathering provisions of the
1796:. Contains extensive information on over-the-counter drugs and their responsible use, including specific guidance on several drug classes in question-and-answer format and information on common
491:
medications. Certain POM medicines are additionally marked
Controlled Drug (CD) due to risk of abuse and the possibility of diversion for sale as street drugs. Examples of CDs include all
413:
passed House Bill 512 in the State Senate on
February 2, 2010 "to require a prescription from a licensed medical professional to purchase over-the-counter medicines with pseudoephedrine,
450:. However, on February 25, 2014, the FDA approved generic one-pill emergency contraception products for unrestricted sale on the shelf. There is no age limit or need for ID to purchase.
146:. Regulations detailing the establishments where drugs may be sold, who is authorized to dispense them, and whether a prescription is required vary considerably from country to country.
623:
It is somewhat unusual for an OTC drug to be withdrawn from the market as a result of safety concerns, rather than market forces, though it does happen occasionally. For example,
462:. Finally, pharmacies frequently require a prescription for Schedule V drugs as a matter of policy, despite their OTC status according to applicable laws and regulations.
1421:
604:
Over time, often 3–6 years, drugs that prove themselves safe and appropriate as prescription medicines may be switched from prescription to OTC. An example of this is
67:
and symbols denoting if they are
Prescription Only Medicine (POM) or Pharmacy Medicine (P), or lacking either, denoting General Sales List (GSL). From top to bottom:
1803:
389:, an OTC product, into locations where customers must ask a pharmacist for them. A prescription is not required; the change has been made in an effort to reduce
1601:
1779:
317:
Examples of OTC substances approved in the United States are sunscreens, anti-microbial and anti-fungal products, external and internal analgesics such as
266:, gas stations, etc. and include only drugs with minimal risk to the public, like paracetamol up to 20 tablets, 200 mg ibuprofen up to 10 tablets,
1276:
828:
1643:
395:
201:
prescription. However, the needed definition had not been enacted by early 2018. The lack of a legal definition for OTC drugs has led to this
1196:
775:
405:, the purchase of pseudoephedrine is restricted. Sellers of pseudoephedrine must obtain and record the identity of the purchaser and enforce
1383:
948:"Changes in Prescription and Over-the-Counter Medication and Dietary Supplement Use Among Older Adults in the United States, 2005 vs 2011"
401:
382:
registered with their state. They may be unavailable in convenience and grocery stores that stock other non-restricted OTC medications.
681:
601:
are available OTC (usually in strictly limited formulations or requiring paperwork or identification to be submitted during purchase).
295:
608:(Benadryl), an anti-histamine which once required a prescription but now is available OTC nearly everywhere. More recent examples are
470:
In the United
Kingdom, medication is governed by the Medicines Regulations 2012. Medication falls into one of three categories:
1771:
234:
A drug that is UA may be sold OTC but only by pharmacists. The drug can be on the shelves like any other product. Examples are
1566:
Alexander GC, Mohajir N, Meltzer DO (2005). "Consumers' perceptions about risk of and access to nonprescription medications".
1355:
802:
1793:
1544:
310:
305:
110:, which may be supplied only to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a
1493:
Sánchez-Sánchez E, Fernández-Cerezo FL, DĂaz-Jimenez J, Rosety-Rodriguez M, DĂaz AJ, Ordonez FJ, et al. (May 2021).
1442:
Sánchez-Sánchez E, Fernández-Cerezo FL, DĂaz-Jimenez J, Rosety-Rodriguez M, DĂaz AJ, Ordonez FJ, et al. (May 2021).
1036:
Sánchez-Sánchez E, Fernández-Cerezo FL, DĂaz-Jimenez J, Rosety-Rodriguez M, DĂaz AJ, Ordonez FJ, et al. (May 2021).
895:
Sánchez-Sánchez E, Fernández-Cerezo FL, DĂaz-Jimenez J, Rosety-Rodriguez M, DĂaz AJ, Ordonez FJ, et al. (May 2021).
657:(previous available as prescription only). Men aged between 30 and 65 could buy four tablets after a consultation with a
1221:
1208:
1712:
17:
1819:
348:
regulates advertising of OTC products, in contrast to prescription drug advertising, which is regulated by the FDA.
1815:
474:
Prescription Only
Medication (POM), which is legally available only with a valid prescription from a prescriber. A
119:
1776:
1862:
716:
435:." However, products containing the substance are still OTC in most states, since no prescription is required.
1258:
1649:
1606:
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1323:
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1246:
576:
287:
749:
701:
299:
1827:
1683:
31:
1688:
1400:
1317:
Over-the-Counter
Monograph User Fee Program Performance Goals and Procedures - Fiscal Years 2018-2022
671:
48:
1185:
1089:"Hypertension and Severe Hypokalemia Associated With Oral Ingestion of Topical Hydrocortisone Cream"
848:"Hypertension and Severe Hypokalemia Associated With Oral Ingestion of Topical Hydrocortisone Cream"
176:
Schedule 1: Requires a prescription for sale and is provided to the public by a licensed pharmacist.
454:
345:
447:
314:, but the FDA has never formally acknowledged that any legitimate grandfathered OTC drug exists.
1380:
1804:
UK Medicines and
Healthcare Products Regulatory Agency list of substances on general sales list
1789:
640:
406:
64:
357:
133:) refers to a medication that can be purchased without a medical prescription. In contrast,
1867:
1492:
1441:
1035:
894:
696:
361:
291:
103:
8:
691:
624:
114:
to ensure that they contain ingredients that are safe and effective when used without a
1521:
1494:
1470:
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1113:
1088:
1064:
1037:
972:
947:
923:
896:
872:
847:
107:
63:
Photo of the packaging of four medicines dispensed in the United Kingdom showing their
1390:. US Department of Justice - Drug Enforcement Administration. Retrieved on 2019-08-26.
1136:
1013:
996:
1797:
1583:
1526:
1475:
1118:
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1018:
977:
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877:
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528:
426:
353:
143:
134:
111:
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1108:
1100:
1059:
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1008:
967:
959:
918:
908:
867:
859:
585:
417:, or any other precursor chemical that can readily and illicitly be converted into
243:
52:
711:
187:
Unscheduled: Does not require a prescription and may be sold in any retail outlet.
1841:
1810:
1783:
1602:"Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac)"
1429:
1387:
605:
572:
556:
492:
484:
418:
390:
386:
1742:
1857:
1104:
863:
532:
997:"Rational use of medicines, pharmaceuticalization and uses of methylphenidate"
304:
Thus, an OTC drug product is allowed to be marketed either (1) pursuant to an
1851:
1670:
1630:
1579:
1342:
1303:
520:
422:
283:
1316:
829:"Prescription Drugs and Over-the-Counter (OTC) Drugs: Questions and Answers"
1587:
1530:
1511:
1479:
1460:
1122:
1073:
1054:
1022:
981:
932:
913:
881:
686:
636:
was suspended in multiple markets due to concerns over the presence of the
488:
263:
1644:"FDA Requests Removal of All Ranitidine Products (Zantac) from the Market"
1161:
30:"Over-the-counter" redirects here. For the securities trading method, see
564:
508:
480:
432:
410:
294:(NDA) before entering interstate commerce, but the act exempts any drugs
259:
255:
235:
214:
80:
68:
519:
as well as a host of other medications such as small pack sizes of some
658:
654:
637:
633:
613:
609:
475:
271:
267:
251:
139:
99:
72:
1720:
1495:"Consumption of over-the-Counter Drugs: Prevalence and Type of Drugs"
1444:"Consumption of over-the-Counter Drugs: Prevalence and Type of Drugs"
1038:"Consumption of over-the-Counter Drugs: Prevalence and Type of Drugs"
897:"Consumption of over-the-Counter Drugs: Prevalence and Type of Drugs"
617:
560:
512:
414:
368:
326:
318:
239:
192:
The drugs found in each schedule may vary from province to province.
115:
1277:"An Exciting New Chapter in OTC Drug History: OTC Monograph Reform"
946:
Qato DM, Wilder J, Schumm LP, Gillet V, Alexander GC (April 2016).
706:
540:
536:
524:
500:
459:
338:
334:
247:
227:
UAD (Uitsluitend Apotheek of Drogist): pharmacist or drugstore only
76:
627:
was removed from sale in the United States over concern regarding
438:
286:, the manufacture and sale of OTC substances are regulated by the
1669:
This article incorporates text from this source, which is in the
1629:
This article incorporates text from this source, which is in the
1499:
International Journal of Environmental Research and Public Health
1448:
International Journal of Environmental Research and Public Health
1341:
This article incorporates text from this source, which is in the
1302:
This article incorporates text from this source, which is in the
1042:
International Journal of Environmental Research and Public Health
901:
International Journal of Environmental Research and Public Health
628:
598:
568:
516:
322:
1087:
Saha A, Balakrishnan S, Trivedi N, Abraham GM (1 January 2023).
846:
Saha A, Balakrishnan S, Trivedi N, Abraham GM (1 January 2023).
1820:
NIDA for Teens: Cough and Cold Medicine (DXM and Codeine Syrup)
496:
330:
169:
142:
after an assessment of the patient's needs or the provision of
1086:
845:
649:
In the United Kingdom, it was announced in February 2007 that
258:, 400 mg ibuprofen up to 20 tablets and also 500 mg
44:
385:
For example, many drugstores have moved products containing
118:'s care. OTC drugs are usually regulated according to their
591:
39:
539:(where they are included in medicinal products), and some
262:
up to 50 tablets. Drugs in the AV category can be sold at
59:
780:
581:
555:
Examples of these include some sleep aid tablets such as
376:
1381:
Controlled Substances Listed in Schedules III, IV, and V
653:
would try over-the-counter sales of Viagra in stores in
341:, and other topical products with a therapeutic effect.
102:
sold directly to a consumer without a requirement for a
1565:
1166:
National Association of Pharmacy Regulatory Authorities
1141:
National Association of Pharmacy Regulatory Authorities
945:
360:
and purpose, safety warnings, directions for use, and
1825:
1222:"Drug Applications for Over-the-Counter (OTC) Drugs"
588:) will be queried, due to the possibility of abuse.
527:
medication, and skin creams. This also includes the
230:
AV (Algemene Verkoop): may be sold in general stores
835:. U.S. Food and Drug Administration. 25 April 2019.
809:. U.S. Food and Drug Administration. 14 August 2019
776:"Over-the-Counter Medicines: What's Right for You?"
446:A similar regulation once applied to some forms of
1209:Drug Applications for Over-the-Counter (OTC) Drugs
370:Coronavirus Aid, Relief, and Economic Security Act
290:. The FDA requires that all "new drugs" obtain a
1849:
1676:
1271:
1269:
1267:
1261:. Fda.gov (2015-06-05). Retrieved on 2019-08-26.
1228:. U.S. Food and Drug Administration. 29 May 2019
1211:. Fda.gov (2015-01-07). Retrieved on 2019-08-26.
1199:. Fda.gov (2015-08-20). Retrieved on 2019-08-26.
1568:Journal of the American Pharmacists Association
1684:"Suspension of ranitidine medicines in the EU"
1636:
396:Illinois Methamphetamine Precursor Control Act
205:market segment being effectively unregulated.
106:from a healthcare professional, as opposed to
1264:
994:
1545:"Phenylpropanolamine (PPA) Information Page"
1594:
1247:Regulation of Nonprescription Drug Products
402:Combat Methamphetamine Epidemic Act of 2005
27:Medication available without a prescription
803:"Understanding Over-the-Counter Medicines"
682:Generally recognized as safe and effective
296:generally recognized as safe and effective
224:UA (Uitsluitend Apotheek): pharmacist only
221:UR (Uitsluitend Recept): prescription only
1559:
1520:
1510:
1469:
1459:
1112:
1063:
1053:
1012:
971:
922:
912:
871:
592:Transitions between prescription and OTC
437:
158:
122:(API) and strengths of final products.
58:
38:
1792:at FamilyDoctor.org, maintained by the
1549:Center for Drug Evaluation and Research
1226:Center for Drug Evaluation and Research
1197:Drug Development and Review Definitions
833:Center for Drug Evaluation and Research
807:Center for Drug Evaluation and Research
14:
1850:
1717:Therapeutic Goods Administration (TGA)
747:
377:Restricted over-the-counter substances
1794:American Academy of Family Physicians
571:(up to 12.8 mg per tablet), and
393:production. Since the passage of the
1614:from the original on 24 October 2019
1137:"NDS Process and Scheduling Factors"
743:
741:
739:
737:
735:
733:
567:, painkillers with small amounts of
311:Federal Food, Drug, and Cosmetic Act
1786:, Tool Box at ConsumerMedSafety.org
995:Esher A, Coutinho T (August 2017).
425:or any active/scheduled analogs of
24:
1777:"Over-the-Counter Medicines Guide"
25:
1879:
1765:
1743:"Over-the-counter Viagra piloted"
1607:U.S. Food and Drug Administration
1249:Fda.gov. Retrieved on 2014-04-24.
1014:10.1590/1413-81232017228.08622017
730:
465:
172:, there are four drug schedules:
1835:
1816:National Institute on Drug Abuse
1790:Over-the-counter (OTC) medicines
1664:
1624:
1432:. MHRA. Retrieved on 2012-07-04.
1336:
1297:
277:
120:active pharmaceutical ingredient
1735:
1705:
1537:
1486:
1435:
1415:
1393:
1374:
1348:
1309:
1252:
1240:
1214:
1202:
1190:
1179:
1154:
1129:
1080:
964:10.1001/jamainternmed.2015.8581
717:Regulation of therapeutic goods
1719:. 2 April 2020. Archived from
1693:(Press release). 30 April 2020
1029:
988:
939:
888:
839:
821:
795:
768:
208:
155:actual improvement of health.
13:
1:
1654:(Press release). 1 April 2020
723:
217:, there are four categories:
1650:Food and Drug Administration
1553:Food and Drug Administration
1324:Food and Drug Administration
1283:Food and Drug Administration
1001:Ciencia & Saude Coletiva
577:Royal Pharmaceutical Society
288:Food and Drug Administration
7:
1422:"Availability of medicines"
1162:"Drug Scheduling in Canada"
702:Over-the-counter counseling
664:
584:, promethazine, codeine or
495:and strong opioids such as
399:and the subsequent federal
300:Code of Federal Regulations
10:
1884:
1772:Complete list of OTC drugs
1105:10.1016/j.aace.2022.10.004
1093:AACE Clinical Case Reports
864:10.1016/j.aace.2022.10.004
852:AACE Clinical Case Reports
748:Millar A (February 2018).
616:in the United States, and
32:Over-the-counter (finance)
29:
1689:European Medicines Agency
672:Child-resistant packaging
333:topical treatments, anti-
163:
49:child-resistant packaging
1580:10.1331/1544345054003868
346:Federal Trade Commission
195:
149:
1401:"Medicines information"
754:Pharma Technology Focus
448:emergency contraception
65:Product Licence Numbers
1863:Pharmaceuticals policy
1512:10.3390/ijerph18115530
1461:10.3390/ijerph18115530
1356:"Princeton University"
1055:10.3390/ijerph18115530
952:JAMA Internal Medicine
914:10.3390/ijerph18115530
443:
84:
56:
712:Ranitidine impurities
644:-nitrosodimethylamine
441:
407:quantity restrictions
242:up to 50 tablets and
159:Regulation by country
62:
42:
1259:OTC Drug Facts Label
750:"Defining OTC Drugs"
697:Medical prescription
597:areas drugs such as
362:inactive ingredients
354:active ingredient(s)
337:shampoos containing
292:New Drug Application
55:carton and innerseal
1610:. 11 October 2019.
1555:. 22 December 2005.
692:Inverse benefit law
655:Manchester, England
625:phenylpropanolamine
1809:2014-03-07 at the
1782:2021-03-09 at the
1749:. 11 February 2007
1428:2010-03-29 at the
1386:2021-03-21 at the
453:Furthermore, some
444:
254:in small amounts,
135:prescription drugs
108:prescription drugs
85:
57:
18:General sales list
1798:drug interactions
1723:on 29 August 2021
1186:Geneesmiddelenwet
1003:(in Portuguese).
677:Drug interactions
651:Boots the Chemist
427:phenylethylamines
144:patient education
112:regulatory agency
16:(Redirected from
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1362:on 19 April 2021
1358:. Archived from
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127:over-the-counter
88:Over-the-counter
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1751:. Retrieved
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1725:. Retrieved
1721:the original
1716:
1713:"Ranitidine"
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1695:. Retrieved
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1656:. Retrieved
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1616:. Retrieved
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1360:the original
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1753:10 February
1330:2 September
1291:2 September
565:mebendazole
531:substances
509:paracetamol
481:antibiotics
433:amphetamine
411:Mississippi
358:indications
260:paracetamol
256:cinnarizine
236:domperidone
215:Netherlands
209:Netherlands
81:paracetamol
69:mebendazole
1852:Categories
1618:23 October
1366:4 February
1099:(1): 2–4.
858:(1): 2–4.
760:3 February
724:References
659:pharmacist
638:carcinogen
634:Ranitidine
614:loratadine
610:cimetidine
476:pharmacist
455:Schedule V
272:loperamide
268:cetirizine
252:diclofenac
140:pharmacist
73:amlodipine
51:(cap) and
1232:26 August
1171:26 August
1146:26 August
813:26 August
618:ibuprofen
561:deworming
513:ibuprofen
415:ephedrine
367:The 2020
327:psoriasis
319:lidocaine
240:ibuprofen
184:required.
125:The term
116:physician
100:medicines
1842:Medicine
1807:Archived
1780:Archived
1612:Archived
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1531:34064096
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1426:Archived
1384:Archived
1123:36654996
1074:34064096
1023:28793073
982:26998708
933:34064096
882:36654996
707:Pharmacy
665:See also
646:(NDMA).
559:, human
541:nicotine
537:caffeine
525:laxative
501:fentanyl
483:and all
460:pharmacy
339:coal tar
335:dandruff
248:naproxen
77:diazepam
1727:19 July
1658:1 April
1551:. U.S.
1522:8196755
1471:8196755
1114:9837079
1065:8196755
973:5024734
924:8196755
873:9837079
629:strokes
599:codeine
569:codeine
533:alcohol
523:, some
517:aspirin
323:aspirin
282:In the
213:In the
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1828:Portal
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515:, and
497:heroin
331:eczema
180:drugs.
170:Canada
164:Canada
83:(GSL).
1858:Drugs
1691:(EMA)
1652:(FDA)
1648:U.S.
1326:(FDA)
1320:(PDF)
1285:(FDA)
1281:U.S.
196:India
150:Usage
96:drugs
71:(P),
45:Bayer
1755:2009
1729:2020
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1660:2020
1620:2019
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1409:2017
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815:2019
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762:2018
756:(67)
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43:OTC
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1576:doi
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909:doi
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860:doi
781:FDA
582:DXM
487:or
168:In
131:OTC
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