Key Information about Nonprescription, Over-the-Counter (OTC), Oral Phenylephrine

… Contents FDA's Actions on OTC Oral Phenylephrine |  Key Information About Cough and Cold Nonprescription Drugs  |  Questions and Answers about Phenylephrine  |  Additional Information   Español FDA’s Actions on OTC Oral Phenylephrine FDA regulates over-the-counter (OTC), also …

FDA clarifies results of recent advisory committee meeting on oral phenylephrine

… Sept. 11-12, 2023, to discuss the effectiveness of oral phenylephrine as an active ingredient in over-the-counter … committee discussed new data on the effectiveness of oral phenylephrine and concluded that the current scientific data … support that the recommended dosage of orally administered phenylephrine is effective as a nasal decongestant. However, …

The Current Status of Oral Phenylephrine as a Nasal Decongestant with Dr. Theresa Michele and Dr. Ilisa Bernstein

… advisory committee meeting on the effectiveness of oral phenylephrine as a nasal decongestant. Oral phenylephrine is an active ingredient found in several … this particular advisory committee meeting for the oral phenylephrine nasal decongestant? Dr. Michele: So, in 2007 …

FDA Proposes Ending Use of Oral Phenylephrine as OTC Monograph Nasal Decongestant Active Ingredient After Extensive Review

… Administration announced it is proposing to remove oral phenylephrine as an active ingredient that can be used in … agency review of the available data determined that oral phenylephrine is not effective for this use. For now, … to market OTC monograph drug products containing oral phenylephrine as a nasal decongestant. This is a proposed …

Sagent Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Phenylephrine Hydrochloride Injection, USP, 10 mg/mL Due to Potential Lack of Sterility Assurance

… announced the voluntary nationwide recall of three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL). This … Inc. Sagent has initiated this voluntary recall of Phenylephrine Hydrochloride Injection, USP to the user level … reports of any adverse events associated with this issue. Phenylephrine Hydrochloride Injection, USP is an alpha-1 …

Leiters Health Issues Voluntary Nationwide Recall of Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags Due to Potential for Superpotent Drug

… user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being … 3/10/2024 2331231 3/24/2024 2331289 3/30/2024 F3360 Phenylephrine HCl 20 mg (80 mcg/mL) (from FDP) added to 0.9% … 2331343 4/1/2024 2331349 4/23/2024 2331433 5/5/2024 F3352 Phenylephrine HCl 40 mg (160 mcg/mL) (from FDP) added to 0.9% …

Phenylephrine/Ketorolac Written Request

… … Phenylephrine/Ketorolac Written Request …

Phenylephrine N203510 Clinical PREA

… … Phenylephrine N203510 Clinical PREA …

Phenylephrine N203510 Statistical PREA

… … Phenylephrine N203510 Statistical PREA …

Phenylephrine N203510 Clinpharm PREA

… … Phenylephrine N203510 Clinpharm PREA …

215352 tropicamide-phenylephrine Statistical prea

… … 215352 tropicamide-phenylephrine Statistical prea …

Phenylephrine hydrochloride Non-Compliance Letter

… … Phenylephrine hydrochloride Non-Compliance Letter …

215352 tropicamide-phenylephrine CDTL DD prea

… … 215352 tropicamide-phenylephrine CDTL DD prea …

214_205388S6 phenylephrine and ketorolac clinical bpca

… … 214_205388S6 phenylephrine and ketorolac clinical bpca …

214_205388s6 phenylephrine and ketorolac clinical bpca

… … 214_205388s6 phenylephrine and ketorolac clinical bpca …

215_205388S6 phenylephrine and ketorolac statistical bpca

… … 215_205388S6 phenylephrine and ketorolac statistical bpca …

215_205388s6 phenylephrine and ketorolac statistical bpca

… … 215_205388s6 phenylephrine and ketorolac statistical bpca …

213_205388s6 phenylephrine and ketorolac cdtl clinical bpca

… … 213_205388s6 phenylephrine and ketorolac cdtl clinical bpca …

213_205388S6 phenylephrine and ketorolac CDTL clinical bpca

… … 213_205388S6 phenylephrine and ketorolac CDTL clinical bpca …

N203826-000 phenylephrine NC ltr (6-8-17)

… … N203826-000 phenylephrine NC ltr (6-8-17) …

Podcast for Q&A Phenylephrine, March 14, 2024

… … Podcast for Q&A Phenylephrine, March 14, 2024 …

N203826-000 phenylephrine PREA Response (7-21-17)

… … N203826-000 phenylephrine PREA Response (7-21-17) …

Unapproved Prescription Cough, Cold, and Allergy Products

… A TAN 12X SUSPENSION PYRILAMINE TANNATE 30 MG 65162 0530 PHENYLEPHRINE TANNATE 5 MG ACCUHIST DM GUAIFENESIN 50 MG … MALEATE 8 MG 066440 2376 METHSCOPOLAMINE NITRATE 2.5 MG PHENYLEPHRINE HYDROCHLORIDE 20 MG AH CHEW SUSPENSION CHLORPHENIRAMINE TANNATE 35 MG 59196 0015 PHENYLEPHRINE TANNATE 25 MG AH CHEW ULTRA CHEWABLE TABLET …

Edge Pharma, LLC Issues Voluntary Nationwide Recall of All Drug Products Due to Lack of Sterility Assurance

… 05446-1179-03 PHENOL, STERILE (PF) 6% 05446-1476-05 PHENYLEPHRINE / TROPICAMIDE / KETOROLAC / CIPROFLOXACIN (PF) 10% / 1% / 0.125% / 0.3% 05446-1270-01 PHENYLEPHRINE HCL 0.1 MG/ML 05446-1544-10 PHENYLEPHRINE HCL 0.1 MG/ML 05446-1545-05 PHENYLEPHRINE HCL …

KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility

… Chloride 500mL IV Bag, Compounded 07242019@9 10/22/2019 Phenylephrine 1.5% / Lidocaine 1% (PF/Sulfite Free) Inj 3mL … fill in a 3mL Syringe, Compounded 08212019@11 10/20/2019 Phenylephrine 1.5% / Lidocaine 1% (PF/Sulfite Free) Inj 3mL fill in a 5mL SDV, Compounded 07172019@16 9/15/2019 Phenylephrine 1.5% / Lidocaine 1% (PF/Sulfite Free) Inj 3mL …