Phenylephrine HCl 10 mg
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- temporarily relieves sinus congestion and pressure
- temporarily relieves nasal congestion due to the common cold, hay fever, or other upper-respiratory allergies
In late 2004, Pfizer publicly disclosed its plans to make available a new over-the-counter product, Sudafed PE, which does not include pseudoephedrine. Decongestants with other ingredients were completely converted to phenylephrine later in 2005. Original Sudafed is still offered behind the counter to customers 18 years of age or older upon request, requiring the customer to show ID and sign a sales log next to a record of their name and address.
The new product was prompted by existing and proposed restrictions on the availability of pseudoephedrine-based products. U.S. state laws imposing such restrictions were in response to pseudoephedrine's role as an ingredient used to synthesize the stimulant methamphetamine.
Pfizer and its predecessor Warner-Lambert had studied at least two alternatives to the pseudoephedrine-containing formula in anticipation of pressure from state regulators and the Food and Drug Administration
In 1996, the company began testing a patented decongestant ingredient known as "minus" pseudoephedrine. The company claimed animal tests showed this altered version offered sinus relief comparable to the current "plus" pseudoephedrine. The difference was that it couldn't be converted to methamphetamine, a prescription only drug used recreationally. Pfizer did not bring the new ingredient to market because of the cost and time involved in gaining regulatory approval.
Pfizer spent US$12 million trying to develop additives for Sudafed that might make it harder to remove the pseudoephedrine it contains. They abandoned the project in 2003, seven years after announcing its existence.
Several pharmacists have questioned the effectiveness of orally-administered phenylephrine as a nasal decongestant. At least one meta-analysis has concluded that it is more effective than placebos, while other research has not found sufficient evidence to support this claim.
Regulation on sale
In the United Kingdom, "Sudafed Decongestant" containing 60 mg of pseudoephedrine hydrochloride per tablet is available in packs of 12 tablets from pharmacies and is classified as a Pharmacy Only Medication ("[P]"), so any sale follows a series of questions from the pharmacist to determine if it is safe. Historically, packs of 24 tablets were also available, but the maximum pack size for OTC sales was reduced to 12 tablets as a measure to counteract misuse. The version that contains phenylephrine is not restricted and may be purchased off the shelf from supermarkets and other stores.
In Australia, Sudafed with up to 60 mg of pseudoephedrine is available subject to a pharmacist matching the purchaser's identity to the Project STOP database to determine if the purchase history is consistent with personal use. Under Project STOP, a maximum of one pseudoephedrine containing drugs can be sold over the counter per day. However, doctors still retain the ability to prescribe the drugs. In Queensland, all pharmacists dispensing pseudoephedrine based substances must use the Project STOP database. If identification is not provided, the pharmacist may, at his or her discretion, still provide the medication.
In the United States, section 711 of the Combat Methamphetamine Epidemic Act of 2005 reclassifies phenylpropanolamine, pseudoephedrine and ephedrine as Schedule Listed Chemicals (SLC). SLCs were reduced by the Federal per-transaction sales limit from 9 grams to 3.6 grams. The amount recently proposed by the Administration requires behind-the-counter storage or locked cabinet storage.
Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
When using this product do not exceed recommended dose
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occurs
- symptoms do not improve within 7 days or occur with a fever
If pregnant or breast-feeding, ask a health professional before use.
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