Acetaminophen + Chlorpheniramine + Pseudoephedrine

Category: Allergies, Cough & Cold



Acetaminophen + Chlorpheniramine + Pseudoephedrine Overview

Paracetamol, also known as acetaminophen and APAP, is a medication used to treat pain and fever.[11][12] It is typically used for mild to moderate pain relief.[11] There is mixed evidence for its use to relieve fever in children.[13][14] It is often sold in combination with other medications, such as in many cold medications.[11] Paracetamol is also used for severe pain, such as cancer pain and pai...

Read more Acetaminophen + Chlorpheniramine + Pseudoephedrine Details
Details May Include Instructions, Side Effects, Interactions, Etc. Drug monograph is from Wikipedia. All text is available under the terms of the GFDL (GNU Free Documentation License). Source: en.wikipedia.org/wiki/Paracetamol

Recent Acetaminophen + Chlorpheniramine + Pseudoephedrine Forums: RSS Feed

Biowaiver for pseudoephedrine

Pseudoephedrine is a BCS class 3 compound. What is needed to get a biowaiver for an EU country (FDA has a more stricter view on BCS class 3)? Would dissolution data work? I can't imagine conducting a BE study for an OTC drug, but can't find justification to waive one. Thank you! ## Although I'm not totally familiar with this topic, I did come across a brief article of information that I thought could be of assistance. Unfortunately it's not European-based, but I hope it helps shed some light on the FDA's level of strictness: "Biopharmaceutics Classification System (BCS) is a regulatory mechanism through which drug developers and generic companies can obtain a waiver of clinical bioequivalence studies, also called a biowaiver. According to the 2000 FDA BCS Guidanc...

Updated

Possible Dosages for this and Related Drugs:

Acetaminophen + Chlorpheniramine + Pseudoephedrine
  • Capsule: 325mg + 2mg + 30mg, 500mg + 2mg + 30mg
  • Liquid: 160mg/5ml + 1mg/5ml + 15mg/5ml
  • Powder for Reconstitution: 1000mg + 4mg + 60mg, 650mg + 4mg + 60mg
  • Tablet: 325mg + 2mg + 30mg, 325mg + 2mg + 5mg, 500mg + 2mg + 30mg, 650mg + 4mg + 60mg, 80mg + 0.5mg + 7.5mg
  • Tablet, Chewable: 80mg + 0.5mg + 7.5mg
Note: Above list includes dosages for all drugs with the same combination of active ingredients.

NDC Database Records for Acetaminophen + Chlorpheniramine + Pseudoephedrine: (2 results)

Sorted by National Drug Code
  • 0363-3420 Apap 500 mg / Chlorpheniramine Maleate 2 mg / Pseudoephedrine Hydrochloride 30 mg Oral Tablet by Walgreen Co.
  • 49789-020 Apap 500 mg / Chlorpheniramine Maleate 2 mg / Pseudoephedrine Hydrochloride 30 mg Oral Tablet by Samsung Pharm Ind. Co., Ltd.

Drugs with one or more similar ingredients: (601 results)

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