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Dover Sudanyl Pe, Medique Medi-Phenyl
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- Active ingredient
- Phenylephrine Hydrochloride 5 mg
- Other brand names
- 4 Way (by Haleon Us Holdings Llc)
- Actifed (by Belmora Llc)
- Basic Care Nasal (by Amazon. Com Services Llc)
- Better Living (by Better Living Brands Llc)
- Bliss Gvs Hemorrhoidal (by Bliss Gvs Pharma Limited)
- Careone Fast Acting Nasal (by American Sales Company)
- Childrens Sudafed Pe (by Kenvue Brands Llc)
- Crane Safety Sinus Decongestant (by Crane Safety Llc)
- Decongestant Pe (by Allegiant Health)
- Dg Health Nasal Four (by Dolgencorp, Llc)
- Dollar General (by Dolgencorp, Inc. (dollar general & rexall))
- Ephrine Nose Drops (by Walgreens)
- Equaline Nasal (by United Natural Foods, Inc. Dba Unfi)
- Equate Nasal (by Wal-Mart Stores Inc)
- Equate Nasal (by Walmart Inc.)
- Extra Strength Nasal (by Cvs Pharmacy)
- Extra Strength Sinus Relief Nasal Decongestant (by Cardinal Health)
- Gencare-Nasal Decongestant Pe (by Pioneer Life Sciences, Llc)
- Gencare-Nasal Decongestant Pe (by Pioneer Life Sciences, Llc)
- Good Neighbor Pharmacy Fast Acting Nasal (by Amerisource Bergen)
- Good Neighbor Pharmacy Nasal Four (by Amerisource Bergen)
- Good Sense Nasal Four (by L. Perrigo Company)
- Green Guard Allergy 2 Relief (by Unifirst First Aid Corporation)
- Heb Nasal (by H E B)
- Maximum Strength Nasal Decongestant (by Spirit Pharmaceuticals Llc)
- Maximum Strength Nasal Decongestant (by Spirit Pharmaceuticals Llc)
- Mckesson Phenylephrine Hcl (by Mckesson Medical-Surgical)
- Medi-First Plus Sinus Decongestant, Medi-First Sinus Decongestant (by Unifirst First Aid Corporation)
- Nasal (by Cvs Pharmacy)
- Nasal (by Kroger Company)
- Nasal (by Meijer, Inc.)
- Nasal (by Walgreen Company)
- Nasal and Sinus Decongestant (by Jhk Inc Dba American Safety & First Aid)
- Nasal Decongestant (by Chain Drug Consortium)
- Nasal Decongestant (by Cvs Pharmacy)
- Nasal Decongestant (by Spirit Pharmaceuticals Llc)
- Nasal Decongestant (by Spirit Pharmaceuticals Llc)
- Nasal Decongestant (by Spirit Pharmaceuticals Llc)
- Nasal Decongestant (by Spirit Pharmaceuticals Llc)
- Nasal Decongestant (by Spirit Pharmaceuticals Llc)
- Nasal Decongestant (by Walgreen Company)
- Nasal Decongestant Pe (by Allegiant Health)
- Nasal Decongestant Pe (by Better Living Brands, Llc)
- Nasal Decongestant Pe (by Bi-Mart)
- Nasal Decongestant Pe (by Cardinal Health 110, Llc. Dba Leader)
- Nasal Decongestant Pe (by Chain Drug Marketing Association Inc)
- Nasal Decongestant Pe (by H E B)
- Nasal Decongestant Pe (by Hhh Pharma Usa Llc)
- Nasal Decongestant Pe (by Nuvicare Llc)
- Nasal Decongestant Pe (by Strategic Sourcing Services Llc)
- Nasal Decongestant Pe (by United Natural Foods, Inc. Dba Unfi)
- Nasal Decongestant Pe (by Winco Foods, Llc)
- Nasal Decongestant Pe (by Yyba Corp)
- Nasal Four (by Meijer Distribution Inc)
- Neo-Synephrine Maximum (by Bf Ascher and Co Inc)
- Neo-Synephrine Mild (by Bf Ascher and Co Inc)
- Neo-Synephrine Regular (by Bf Ascher and Co Inc)
- Pe Sinus Congestion (by Topco Associates, Llc)
- Phenylephrine Hcl (by Rugby Laboratories)
- Phenylephrine Hemorrhoidal (by Neilmed Pharmaceuticals Inc.)
- Phenylephrine Hydrochloride (by Hhh Pharma Usa Llc)
- Phenylephrine Hydrochloride (by Invatech Pharma Solutions Llc)
- Physicianscare Sinus (by Acme United Corporation)
- Preparation H (by Haleon Us Holdings Llc)
- Preparation H (by Haleon Us Holdings Llc)
- Publix (by Publix Super Markets, Inc)
- Quality Choice (by Chain Drug Marketing Association)
- Quality Choice (by Chain Drug Marketing Association)
- Redicare Nasal and Sinus Decongestant (by Redicare Llc)
- Revivol-Xr (by Unipack Llc)
- Sinus Congestion (by Chain Drug Marketing Association, Inc.)
- Sinus Congestion (by Kroger Company)
- Sinus Congestion (by L. N. K. International, Inc.)
- Sinus Congestion (by L. N. K. International, Inc.)
- Sinus Congestion Pe (by Walmart Inc.)
- Sinus Congestion Relief (by Gobrands, Inc)
- Sinus Pressure and Congestion Relief Pe (by Rite Aid Corporation)
- Su Phedrine Pe (by Salado Sales, Inc.)
- Su Phedrine Pe (by Salado Sales, Inc.)
- Sudafed Pe Sinus Congestion (by Kenvue Brands Llc)
- Suphedrine Pe Sinus Congestion (by Army and Air Force Exchange Service)
- Topcare Nasal Four (by Topco Associates Llc)
- Uline Sinus and Congestion (by Uline)
- Unishield Sinus Decongestant (by Unishield)
- Valumeds Nasal Decongestant Phenylephrine Hcl (by Cabinet Health P. B. C.)
- View full label-group details →
- Drug class
- alpha-1 Adrenergic Agonist
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2008
- Label revision date
- September 8, 2025
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Phenylephrine Hydrochloride 5 mg
- Other brand names
- 4 Way (by Haleon Us Holdings Llc)
- Actifed (by Belmora Llc)
- Basic Care Nasal (by Amazon. Com Services Llc)
- Better Living (by Better Living Brands Llc)
- Bliss Gvs Hemorrhoidal (by Bliss Gvs Pharma Limited)
- Careone Fast Acting Nasal (by American Sales Company)
- Childrens Sudafed Pe (by Kenvue Brands Llc)
- Crane Safety Sinus Decongestant (by Crane Safety Llc)
- Decongestant Pe (by Allegiant Health)
- Dg Health Nasal Four (by Dolgencorp, Llc)
- Dollar General (by Dolgencorp, Inc. (dollar general & rexall))
- Ephrine Nose Drops (by Walgreens)
- Equaline Nasal (by United Natural Foods, Inc. Dba Unfi)
- Equate Nasal (by Wal-Mart Stores Inc)
- Equate Nasal (by Walmart Inc.)
- Extra Strength Nasal (by Cvs Pharmacy)
- Extra Strength Sinus Relief Nasal Decongestant (by Cardinal Health)
- Gencare-Nasal Decongestant Pe (by Pioneer Life Sciences, Llc)
- Gencare-Nasal Decongestant Pe (by Pioneer Life Sciences, Llc)
- Good Neighbor Pharmacy Fast Acting Nasal (by Amerisource Bergen)
- Good Neighbor Pharmacy Nasal Four (by Amerisource Bergen)
- Good Sense Nasal Four (by L. Perrigo Company)
- Green Guard Allergy 2 Relief (by Unifirst First Aid Corporation)
- Heb Nasal (by H E B)
- Maximum Strength Nasal Decongestant (by Spirit Pharmaceuticals Llc)
- Maximum Strength Nasal Decongestant (by Spirit Pharmaceuticals Llc)
- Mckesson Phenylephrine Hcl (by Mckesson Medical-Surgical)
- Medi-First Plus Sinus Decongestant, Medi-First Sinus Decongestant (by Unifirst First Aid Corporation)
- Nasal (by Cvs Pharmacy)
- Nasal (by Kroger Company)
- Nasal (by Meijer, Inc.)
- Nasal (by Walgreen Company)
- Nasal and Sinus Decongestant (by Jhk Inc Dba American Safety & First Aid)
- Nasal Decongestant (by Chain Drug Consortium)
- Nasal Decongestant (by Cvs Pharmacy)
- Nasal Decongestant (by Spirit Pharmaceuticals Llc)
- Nasal Decongestant (by Spirit Pharmaceuticals Llc)
- Nasal Decongestant (by Spirit Pharmaceuticals Llc)
- Nasal Decongestant (by Spirit Pharmaceuticals Llc)
- Nasal Decongestant (by Spirit Pharmaceuticals Llc)
- Nasal Decongestant (by Walgreen Company)
- Nasal Decongestant Pe (by Allegiant Health)
- Nasal Decongestant Pe (by Better Living Brands, Llc)
- Nasal Decongestant Pe (by Bi-Mart)
- Nasal Decongestant Pe (by Cardinal Health 110, Llc. Dba Leader)
- Nasal Decongestant Pe (by Chain Drug Marketing Association Inc)
- Nasal Decongestant Pe (by H E B)
- Nasal Decongestant Pe (by Hhh Pharma Usa Llc)
- Nasal Decongestant Pe (by Nuvicare Llc)
- Nasal Decongestant Pe (by Strategic Sourcing Services Llc)
- Nasal Decongestant Pe (by United Natural Foods, Inc. Dba Unfi)
- Nasal Decongestant Pe (by Winco Foods, Llc)
- Nasal Decongestant Pe (by Yyba Corp)
- Nasal Four (by Meijer Distribution Inc)
- Neo-Synephrine Maximum (by Bf Ascher and Co Inc)
- Neo-Synephrine Mild (by Bf Ascher and Co Inc)
- Neo-Synephrine Regular (by Bf Ascher and Co Inc)
- Pe Sinus Congestion (by Topco Associates, Llc)
- Phenylephrine Hcl (by Rugby Laboratories)
- Phenylephrine Hemorrhoidal (by Neilmed Pharmaceuticals Inc.)
- Phenylephrine Hydrochloride (by Hhh Pharma Usa Llc)
- Phenylephrine Hydrochloride (by Invatech Pharma Solutions Llc)
- Physicianscare Sinus (by Acme United Corporation)
- Preparation H (by Haleon Us Holdings Llc)
- Preparation H (by Haleon Us Holdings Llc)
- Publix (by Publix Super Markets, Inc)
- Quality Choice (by Chain Drug Marketing Association)
- Quality Choice (by Chain Drug Marketing Association)
- Redicare Nasal and Sinus Decongestant (by Redicare Llc)
- Revivol-Xr (by Unipack Llc)
- Sinus Congestion (by Chain Drug Marketing Association, Inc.)
- Sinus Congestion (by Kroger Company)
- Sinus Congestion (by L. N. K. International, Inc.)
- Sinus Congestion (by L. N. K. International, Inc.)
- Sinus Congestion Pe (by Walmart Inc.)
- Sinus Congestion Relief (by Gobrands, Inc)
- Sinus Pressure and Congestion Relief Pe (by Rite Aid Corporation)
- Su Phedrine Pe (by Salado Sales, Inc.)
- Su Phedrine Pe (by Salado Sales, Inc.)
- Sudafed Pe Sinus Congestion (by Kenvue Brands Llc)
- Suphedrine Pe Sinus Congestion (by Army and Air Force Exchange Service)
- Topcare Nasal Four (by Topco Associates Llc)
- Uline Sinus and Congestion (by Uline)
- Unishield Sinus Decongestant (by Unishield)
- Valumeds Nasal Decongestant Phenylephrine Hcl (by Cabinet Health P. B. C.)
- View full label-group details →
- Drug class
- alpha-1 Adrenergic Agonist
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Prescription status
- OTC (over the counter)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2008
- Label revision date
- September 8, 2025
- Manufacturer
- Unifirst First Aid Corporation
- Registration number
- M012
- NDC roots
- 47682-161, 47682-162
- Drug Information (PDF)
- Prescribing information, PDF file
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
If you are a consumer or patient please visit this version.
Drug Overview
Medique® Medi-Phenyl is a nasal decongestant that contains phenylephrine HCl (a medication that helps relieve nasal congestion). It is designed to temporarily relieve nasal congestion caused by the common cold, hay fever, or other upper respiratory allergies, as well as to alleviate sinus congestion and pressure.
This medication is free from pseudoephedrine, making it a suitable option for those who may need to avoid that ingredient. Medique® Medi-Phenyl comes in a convenient packaging of 500 tablets, ensuring you have an ample supply for when you need relief from nasal discomfort.
Uses
If you're dealing with nasal congestion from a common cold, hay fever, or other upper respiratory allergies, this medication can help provide temporary relief. It works by easing the swelling in your nasal passages, making it easier for you to breathe.
Additionally, if you're experiencing sinus congestion and pressure, this medication can also help alleviate those symptoms. It's designed to make you feel more comfortable when you're dealing with these common respiratory issues.
Dosage and Administration
When using this medication, it's important to follow the directions carefully. You should never use more than the amount that has been directed for you. This ensures that you are using the medication safely and effectively. Always check with your healthcare provider if you have any questions about how much to take or apply. Remember, sticking to the recommended dosage is key to achieving the best results while minimizing any potential risks.
What to Avoid
You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, psychiatric conditions, or Parkinson's disease. Additionally, you should not use this product for at least two weeks after stopping an MAOI. If you're unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist before using this product.
It's also important to follow the recommended dosage carefully. Do not exceed the suggested amount, as misuse can lead to serious health issues. Always prioritize your safety and well-being by adhering to these guidelines.
Side Effects
If you experience nervousness, dizziness, or sleeplessness while using this medication, it's important to stop use and consult your doctor. Additionally, if your symptoms do not improve within 7 days or are accompanied by a fever, seek medical advice.
Before starting this medication, you should talk to your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.
Warnings and Precautions
Before using this medication, it's important to consult your doctor if you have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. These conditions may affect how the medication works for you.
If you suspect an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. Additionally, you should stop taking the medication and reach out to your doctor if you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within 7 days or are accompanied by a fever. Your health and safety are the top priority, so don’t hesitate to ask for help when needed.
Overdose
It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.
In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.
Pregnancy Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.
Lactation Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey and any medications you may consider.
Pediatric Use
If your child is under 12 years old, it's important to consult with a doctor before using this medication. For those aged 12 and older, the recommended dosage is 2 tablets every 4 to 6 hours, but be sure not to exceed 12 tablets in a 24-hour period. Always follow these guidelines to ensure safe and effective use.
Geriatric Use
While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.
Renal Impairment
If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Specifically, if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste), your healthcare provider will closely monitor your condition. Regular renal function tests (tests that check how well your kidneys are working) should be performed to ensure your safety.
For those with significant renal impairment, a reduced dose of medication is recommended. Always communicate with your healthcare team about your kidney health to ensure you receive the appropriate care and adjustments to your treatment plan.
Hepatic Impairment
If you have liver problems, it's important to know that your condition may affect how this medication works in your body. Because of this, your doctor might need to adjust your dosage to ensure it's safe and effective for you.
Additionally, if you have a pre-existing liver condition, your healthcare provider will likely monitor your liver function tests (which check how well your liver is working) more closely. Special precautions will be taken when administering this drug to ensure your safety and well-being. Always discuss any concerns with your healthcare provider.
Drug Interactions
It's important to be cautious when taking phenylephrine, especially if you are also using monoamine oxidase inhibitors (MAOIs), a type of medication often prescribed for depression. Using phenylephrine while on MAOIs or within two weeks of stopping them can lead to a serious increase in blood pressure, known as a hypertensive crisis.
Always discuss your current medications and any recent changes with your healthcare provider. This ensures that you avoid potentially dangerous interactions and receive the safest and most effective treatment for your needs.
Storage and Handling
To ensure the best quality and safety of your product, store it at room temperature, ideally between 59º-86º F (15º-30º C). It's important to keep the packets sealed until you're ready to use them, as they come in tamper-evident sealed packets designed to protect the contents.
If you notice that any packets are opened or torn, do not use them, as this could compromise the safety and effectiveness of the product. Always handle the packets with care to maintain their integrity.
Additional Information
No further information is available.
FAQ
What is Medique® Medi-Phenyl used for?
Medique® Medi-Phenyl is used to temporarily relieve nasal congestion due to the common cold, hay fever, or other upper respiratory allergies, as well as sinus congestion and pressure.
What is the active ingredient in Medique® Medi-Phenyl?
The active ingredient in Medique® Medi-Phenyl is Phenylephrine HCl, which is a nasal decongestant.
What should I do if I am taking a monoamine oxidase inhibitor (MAOI)?
Do not use Medique® Medi-Phenyl if you are currently taking a prescription MAOI or for 2 weeks after stopping an MAOI. Consult your doctor or pharmacist if you are unsure.
What are the dosage instructions for adults and children over 12?
Adults and children 12 years and older should take 2 tablets every 4-6 hours, not exceeding 12 tablets in 24 hours.
Are there any warnings I should be aware of?
You should stop use and consult a doctor if you experience nervousness, dizziness, sleeplessness, or if symptoms do not improve within 7 days or are accompanied by fever.
What should I do in case of an overdose?
In case of overdose, seek emergency medical help or contact a Poison Control Center immediately at 1-800-222-1222.
Can I use Medique® Medi-Phenyl if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, you should ask a health professional before using Medique® Medi-Phenyl.
How should I store Medique® Medi-Phenyl?
Store Medique® Medi-Phenyl at room temperature between 59º-86º F (15º-30º C) and do not use any opened or torn packets.
Packaging Info
Below are the non-prescription pack sizes of Dover Sudanyl Pe, Medique Medi-Phenyl (phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated | 5 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 5 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 5 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 5 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 5 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Dover Sudanyl Pe, Medique Medi-Phenyl, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
No description information is available for the specified drug.
Uses and Indications
This drug is indicated for the temporary relief of nasal congestion associated with the common cold, hay fever, or other upper respiratory allergies. Additionally, it provides temporary relief from sinus congestion and pressure.
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
Healthcare professionals are advised to adhere strictly to the prescribed dosage and administration guidelines. The medication should not be used in excess of the directed amount.
It is essential to ensure that the dosage is tailored to the individual patient's needs, taking into consideration their specific medical condition and response to treatment. Careful monitoring is recommended to avoid any potential adverse effects associated with overuse.
Preparation and administration techniques should follow standard protocols to ensure safety and efficacy.
Contraindications
Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.
Exceeding the recommended dosage while using this product is also contraindicated.
Warnings and Precautions
Healthcare professionals should exercise caution when prescribing this medication. It is imperative to consult a physician prior to use in patients with a history of heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland. These conditions may increase the risk of adverse effects or complications associated with the medication.
In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance.
Patients should be instructed to discontinue use and consult their healthcare provider if they experience symptoms such as nervousness, dizziness, or insomnia. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, it is crucial to seek medical advice promptly. Monitoring for these symptoms is essential to ensure patient safety and effective management of their condition.
Side Effects
Patients should be advised to discontinue use and consult a healthcare professional if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, medical advice should be sought.
Before initiating treatment, it is important for patients to inform their healthcare provider if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. These conditions may influence the safety and efficacy of the treatment.
Drug Interactions
Phenylephrine is contraindicated for use in conjunction with monoamine oxidase inhibitors (MAOIs) or within 2 weeks following the discontinuation of an MAOI. The combination may lead to a hypertensive crisis, which poses significant clinical risks.
No additional drug interactions or laboratory test interactions have been identified for phenylephrine. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the aforementioned contraindication.
Packaging & NDC
Below are the non-prescription pack sizes of Dover Sudanyl Pe, Medique Medi-Phenyl (phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated | 5 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 5 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 5 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 5 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Tablet, Film Coated | 5 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 tablets every 4 to 6 hours, with a maximum of 12 tablets within a 24-hour period.
Geriatric Use
There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have different pharmacokinetic and pharmacodynamic responses compared to younger populations. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this demographic, given the lack of targeted data.
Pregnancy
Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.
Lactation
Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.
Renal Impairment
Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that patients with reduced creatinine clearance are closely monitored to ensure safety and efficacy. Regular renal function tests should be performed in patients with kidney problems to assess their condition. A reduced dose is recommended for patients with significant renal impairment to mitigate the risk of adverse effects.
Hepatic Impairment
Hepatic impairment may affect the pharmacokinetics of the drug, necessitating dosage adjustments for patients with compromised liver function. It is essential to monitor liver function tests in patients with pre-existing liver conditions to ensure safety and efficacy. Special precautions should be taken when administering the drug to this population to mitigate potential risks associated with altered drug metabolism and clearance.
Overdosage
In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication.
Should an overdose occur, it is crucial to monitor the patient closely for any adverse effects. Symptoms of overdose may vary depending on the specific medication and the individual patient's response. Commonly observed symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory depression, or other significant alterations in physiological status.
In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare professionals should initiate supportive care, which may include monitoring vital signs, providing oxygen if necessary, and ensuring the patient’s safety.
Activated charcoal may be considered if the patient presents within a suitable timeframe post-ingestion, and the decision should be based on clinical judgment. Additionally, specific antidotes or treatments may be indicated depending on the medication involved and the severity of the overdose.
It is imperative to consult local poison control guidelines and the product's prescribing information for detailed management recommendations tailored to the specific circumstances of the overdose. Continuous assessment and supportive care are vital components of managing an overdose effectively.
Nonclinical Toxicology
There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, there are no details provided concerning animal pharmacology and toxicology.
Postmarketing Experience
No postmarketing experience details are available in the provided text.
Patient Counseling
Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.
Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should consult with their doctor or pharmacist prior to using this product.
Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop using the product and seek medical advice if their symptoms do not improve within seven days or if they are accompanied by a fever.
It is important to remind patients not to exceed the recommended dosage while using this product. Providers should also encourage patients to consult a doctor before use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland.
Storage and Handling
The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to store the packets at room temperature, specifically within the range of 59º to 86º F (15º to 30º C). Healthcare professionals are advised to refrain from using any packets that are opened or torn, as this may compromise the product's quality and efficacy.
Additional Clinical Information
No further data are available.
Drug Information (PDF)
This file contains official product information for Dover Sudanyl Pe, Medique Medi-Phenyl, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.