Sudafed 12 hour, Aerinaze(pseudoephedrine)
/ / Pseudoephedrine, / Pseudoephedrine, Actahist, Actifed, Advil, Aerinaze, Afrinol, Allegr, Allerfed, Benylin, Bromfed-dm, Brompheril, Chlor-trimeton, Clarinex, Claritin, Codimal-l.a, Corphed, Disobrom, Disophrol, Drixoral, Histafed, Hycofenix, Ibuprohm, Isoclor, Motrin, Mucinex D, Myfed, Pseudoephedrine, Resporal, Rezira, Semprex, Sine-aid, Sudafed, Tavist, Triacin-c, Trilitron, Trinalin, Triphed, Zyrtec (pseudoephedrine) is a small molecule pharmaceutical. Pseudoephedrine was first approved as Chlor-trimeton on 1982-01-01. It is used to treat allergic rhinitis perennial, asthma, common cold, and sinusitis in the USA. It has been approved in Europe to treat allergic rhinitis seasonal.
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Trade Name
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Pseudoephedrine, Sudafed (discontinued: Afrinol, Novafed, Pseudo, Sudafed)
CombinationsAdvil, Allegr, Bromfed-dm, Brompheniramine maleate, pseudoephedrine dextromethorphan, Cetirizine pseudoephedrine, Clarinex, Claritin, Desloratadine pseudoephedrine, Fexofenadine pseudoephedrine, Guaifenesin pseudoephedrine, Hydrocodone bitartrate, chlorpheniramine pseudoephedrine, Ibuprofen pseudoephedrine, Loratadine pseudoephedrine, Motrin, Mucinex d, Naproxen pseudoephedrine, Sine-aid, Zyrtec (discontinued: Actifed, Aleve, Allerfed, Benylin, Bromanate, Bromfed-dm, Brompheniramine maleate, pseudoephedrine dextromethorphan, Brompheril, Cetirizine pseudoephedrine, Chlor-trimeton, Clarinex d, Codimal-l.a., Corphed, Dimetane-dx, Disobrom, Disophrol, Drixoral, Efidac 24 pseudoephedrine hydrochloride/brompheniramine, Fexofenadine pseudoephedrine, Guaifenesin pseudoephedrine, Hycofenix, Hydrocodone bitartrate, chlorpheniramine pseudoephedrine, Hydrocodone pseudoephedrine, Ibuprofen pseudoephedrine, Isoclor, Pseudoephedrine chlorpheniramine, Pseudoephedrine triprolidine, Rezira, Semprex, Tavist, Trinalin, Triphed, Triprolidine hydrochloride, pseudoephedrine codeine, Triprolidine pseudoephedrine, Triprolidine pseudoephedrine hydrochlorides, Zutripro)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ibuprofen
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Pseudoephedrine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ADVIL COLD AND SINUS | GSK | N-019771 OTC | 1989-09-19 | 1 products, RLD, RS |
| CHILDREN'S ADVIL COLD | GSK | N-021373 OTC | 2002-04-18 | 1 products |
| ADVIL COLD AND SINUS | GSK | N-021374 OTC | 2002-05-30 | 1 products, RLD, RS |
| CHILDREN'S MOTRIN COLD | Johnson & Johnson | N-021128 OTC | 2000-08-01 | 1 products, RLD, RS |
| SINE-AID IB | Johnson & Johnson | N-019899 OTC | 1992-12-31 | 1 products |
Pseudoephedrine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SUDAFED 24 HOUR | Johnson & Johnson | N-020021 OTC | 1992-12-15 | 1 products, RLD, RS |
Show 2 discontinued
Cetirizine hydrochloride
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Pseudoephedrine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZYRTEC-D 12 HOUR | Johnson & Johnson | N-021150 OTC | 2007-11-09 | 1 products, RLD, RS |
Codeine phosphate
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Pseudoephedrine hydrochloride
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Triprolidine hydrochloride
Pseudoephedrine hydrochloride
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Triprolidine hydrochloride
Chlorpheniramine maleate
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Ibuprofen
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Pseudoephedrine hydrochloride
Desloratadine
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Pseudoephedrine sulfate
Acetaminophen
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Clemastine fumarate
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Pseudoephedrine hydrochloride
Fexofenadine hydrochloride
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Pseudoephedrine hydrochloride
Pseudoephedrine polistirex
Pseudoephedrine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AFRINOL | Merck & Co | N-018191 DISCN | 1982-01-01 | 1 products, RLD |
Hide discontinued
Dexbrompheniramine maleate
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Pseudoephedrine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DISOPHROL | Merck & Co | N-012394 DISCN | 1982-01-01 | 1 products |
| DRIXORAL | Merck & Co | N-013483 DISCN | 1982-09-13 | 1 products, RLD |
| DISOPHROL | Merck & Co | N-013483 DISCN | 1982-09-13 | 1 products |
Hide discontinued
Acetaminophen
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Dexbrompheniramine maleate
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Pseudoephedrine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DRIXORAL PLUS | Merck & Co | N-019453 DISCN | 1987-05-22 | 1 products |
Hide discontinued
Azatadine maleate
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Pseudoephedrine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TRINALIN | Merck & Co | N-018506 DISCN | 1982-03-23 | 1 products |
Hide discontinued
Naproxen sodium
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Pseudoephedrine hydrochloride
Chlorpheniramine maleate
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Pseudoephedrine sulfate
Loratadine
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Pseudoephedrine sulfate
Diphenhydramine hydrochloride
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Pseudoephedrine hydrochloride
Guaifenesin
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Hydrocodone bitartrate
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Pseudoephedrine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| HYCOFENIX | Chartwell Pharmaceuticals | N-022279 DISCN | 2015-05-14 | 1 products, RLD |
Hide discontinued
Chlorpheniramine maleate
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Pseudoephedrine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE | Central Pharmaceuticals | N-019428 DISCN | 1988-08-02 | 1 products |
| ISOCLOR | Fisons | N-018747 DISCN | 1986-03-06 | 1 products |
| CODIMAL-L.A. 12 | Schwarz Pharma | N-018935 DISCN | 1985-04-15 | 1 products |
Hide discontinued
Acrivastine
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Pseudoephedrine hydrochloride
Brompheniramine maleate
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Dextromethorphan hydrobromide
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Pseudoephedrine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DIMETANE-DX | A.H. Robins Company | N-019279 DISCN | 1984-08-24 | 1 products, RLD |
Hide discontinued
Brompheniramine maleate
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Pseudoephedrine hydrochloride
Hydrocodone bitartrate
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Pseudoephedrine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| REZIRA | Persion Pharmaceuticals | N-022442 DISCN | 2011-06-08 | 1 products, RLD |
Hide discontinued
Chlorpheniramine maleate
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Hydrocodone bitartrate
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Pseudoephedrine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZUTRIPRO | Persion Pharmaceuticals | N-022439 DISCN | 2011-06-08 | 1 products, RLD |
Hide discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 12 hour allergy d | ANDA | 2020-09-03 |
| 12 hour nasal decongestant | ANDA | 2024-05-20 |
| 12hr allergy and congestion relief | ANDA | 2024-10-29 |
| abatuss dmx | OTC monograph final | 2022-10-28 |
| acticon | C200263 | 2024-06-28 |
| actifed | C200263 | 2024-10-04 |
| actinel | C200263 | 2024-06-27 |
| actinel pediatric | C200263 | 2024-06-28 |
| advil | New Drug Application | 2024-07-19 |
| advil allergy and congestion relief | New Drug Application | 2024-06-20 |
Show 292 more
Indications
FDA
EMA
Show 30 more
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Chlorpheniramine Maleate / Ibuprofen / Pseudoephedrine Hydrochloride, Advil Allergy Sinus, Haleon Us Holdings | |||
| 7863287 | 2027-02-28 | DP | |
| Chlorpheniramine Maleate / Ibuprofen / Pseudoephedrine Hydrochloride, Children'S Advil Allergy Sinus, Haleon Us Holdings | |||
| 10238640 | 2024-05-25 | DP | |
HCPCS
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Clinical
Clinical Trials
2133 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | 9 | 22 | 34 | 55 | 66 | 181 |
| Healthy volunteers/patients | — | — | — | 127 | 3 | 1 | 7 | 20 | 157 |
| Pain | D010146 | EFO_0003843 | R52 | 24 | 25 | 33 | 39 | 34 | 152 |
| Rhinitis | D012220 | EFO_0008521 | J31 | 7 | 26 | 56 | 42 | 20 | 150 |
| Allergic rhinitis | D065631 | — | J30.9 | 6 | 23 | 48 | 41 | 18 | 135 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 14 | 27 | 27 | 18 | 17 | 100 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | 3 | 12 | 23 | 20 | 7 | 65 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 6 | 19 | 13 | 10 | 15 | 61 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | 4 | 3 | 21 | 19 | 12 | 58 |
| Hypotension | D007022 | EFO_0005251 | I95 | 2 | 6 | 6 | 14 | 30 | 55 |
Show 292 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 4 | 5 | 2 | — | 10 | 19 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | 2 | 1 | 6 | — | 3 | 12 |
| Psychomotor agitation | D011595 | — | — | — | 2 | 6 | — | 1 | 9 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 2 | 2 | — | 4 | 8 |
| Lymphoma | D008223 | — | C85.9 | 4 | 3 | 1 | — | 1 | 8 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | 2 | 2 | — | 2 | 7 |
| Stomach ulcer | D013276 | — | K25 | 1 | 2 | 6 | — | — | 7 |
| Spondylitis | D013166 | — | M46.9 | — | 1 | 3 | — | 2 | 6 |
| Local anesthesia | D000772 | — | — | — | 2 | 1 | — | 4 | 6 |
| Head and neck neoplasms | D006258 | — | — | 1 | 3 | 2 | — | 1 | 6 |
Show 118 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 1 | 4 | — | — | 2 | 6 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 4 | 2 | — | — | — | 6 |
| Hepatitis b | D006509 | — | — | 1 | 5 | — | — | — | 6 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 1 | 5 | — | — | — | 6 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 1 | 5 | — | — | — | 6 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | 5 | — | — | — | 6 |
| Disease | D004194 | EFO_0000408 | R69 | 1 | 1 | — | — | 4 | 5 |
| Foot and mouth disease hand | D006232 | EFO_0007294 | B08.4 | — | 1 | — | — | 4 | 5 |
| Mouth diseases | D009059 | EFO_1001047 | K13 | — | 1 | — | — | 4 | 5 |
| Foot-and-mouth disease | D005536 | EFO_0007277 | B08.8 | — | 1 | — | — | 4 | 5 |
Show 178 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 15 | — | — | — | 2 | 17 |
| Drug interactions | D004347 | — | — | 10 | — | — | — | 3 | 13 |
| Therapeutic equivalency | D013810 | — | — | 10 | — | — | — | — | 10 |
| Pharmacokinetics | D010599 | — | — | 4 | — | — | — | 1 | 5 |
| Pure autonomic failure | D054970 | — | — | 3 | — | — | — | — | 3 |
| Food-drug interactions | D018565 | — | — | 2 | — | — | — | — | 2 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | 1 | 2 |
| Voice disorders | D014832 | — | — | 2 | — | — | — | — | 2 |
| Thyroid diseases | D013959 | HP_0000820 | E00-E07 | 1 | — | — | — | 1 | 2 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | 1 | 2 |
Show 52 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pneumonia | D011014 | EFO_0003106 | — | — | — | — | — | 5 | 5 |
| Cholecystitis | D002764 | HP_0001082 | K81 | — | — | — | — | 5 | 5 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | — | — | 5 | 5 |
| Hysterectomy | D007044 | EFO_0003881 | — | — | — | — | — | 4 | 4 |
| Acute cholecystitis | D041881 | EFO_1001289 | K81.0 | — | — | — | — | 4 | 4 |
| Acalculous cholecystitis | D042101 | EFO_1000790 | — | — | — | — | — | 4 | 4 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | — | — | — | 3 | 3 |
| Respiration disorders | D012120 | — | J00-J99 | — | — | — | — | 3 | 3 |
| Trismus | D014313 | — | — | — | — | — | — | 3 | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 3 | 3 |
Show 205 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pseudoephedrine |
| INN | pseudoephedrine |
| Description | Pseudoephedrine is a member of the class of the class of phenylethanolamines that is (1S)-2-(methylamino)-1-phenylethan-1-ol in which the pro-S hydrogen at position 2 is replaced by a methyl group. It has a role as a sympathomimetic agent, an anti-asthmatic drug, a bronchodilator agent, a vasoconstrictor agent, a central nervous system drug, a nasal decongestant, a xenobiotic and a plant metabolite. It is a secondary alcohol, a secondary amino compound and a member of phenylethanolamines. It is a conjugate base of a pseudoephedrine(1+). |
| Classification | Small molecule |
| Drug class | sympathomimetics |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN[C@@H](C)[C@@H](O)c1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 90-82-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1590 |
| ChEBI ID | 51209 |
| PubChem CID | 7028 |
| DrugBank | DB00852 |
| UNII ID | 7CUC9DDI9F (ChemIDplus, GSRS) |
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Clarinex – Organon
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Pseudoephedrine
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Acetaminophen
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Pseudoephedrine
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Acrivastine
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Pseudoephedrine
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Azatadine
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Pseudoephedrine
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Brompheniramine
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Pseudoephedrine
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Carbetapentane
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Pseudoephedrine
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Carbinoxamine
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Pseudoephedrine
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Cetirizine
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Pseudoephedrine
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Chlorpheniramine
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Pseudoephedrine
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Codeine
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Pseudoephedrine
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Desloratadine
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Pseudoephedrine
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Dexbrompheniramine
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Pseudoephedrine
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Dexchlorpheniramine
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Pseudoephedrine
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Dextromethorphan
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Pseudoephedrine
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Doxylamine
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Pseudoephedrine
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Fexofenadine
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Pseudoephedrine
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Guaifenesin
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Pseudoephedrine
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Hydrocodone
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Pseudoephedrine
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Ibuprofen
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Pseudoephedrine
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Loratadine
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Pseudoephedrine
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Methscopolamine
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Pseudoephedrine
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Naproxen
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Pseudoephedrine
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Pseudoephedrine
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Terfenadine
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Triprolidine
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Trends
PubMed Central
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Additional graphs summarizing 5,417 documents
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Safety
Black-box Warning
Black-box warning for: Triacin-c
Adverse Events
Top Adverse Reactions
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202,127 adverse events reported
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