ADD CONDITION
Sinus Congestion Pe
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- Active ingredient
- Phenylephrine Hydrochloride 10 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))
- Dover Sudanyl Pe, Medique Medi-Phenyl (by Unifirst First Aid Corporation)
- 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 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 2021
- Label revision date
- July 21, 2025
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Phenylephrine Hydrochloride 10 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))
- Dover Sudanyl Pe, Medique Medi-Phenyl (by Unifirst First Aid Corporation)
- 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 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 2021
- Label revision date
- July 21, 2025
- Manufacturer
- WALMART INC.
- Registration number
- M012
- NDC root
- 79903-076
- 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
Equate™ is a non-drowsy nasal decongestant that contains 10 mg of 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 sinus congestion and pressure.
This maximum strength formula can help you breathe more easily by alleviating sinus pressure and nasal congestion. If you're looking for relief from these symptoms, Equate™ may be a suitable option for you.
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
If you are an adult or a child aged 12 years and older, you should take 1 tablet every 4 hours as needed. However, it’s important not to exceed 6 tablets in a 24-hour period to ensure your safety.
For children under 12 years old, it’s best to consult a doctor before giving them this medication. This way, you can ensure they receive the appropriate care and dosage. Always follow these guidelines to use the medication safely and effectively.
What to Avoid
You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which are certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, do not use this product for at least two weeks after stopping an MAOI. If you are unsure whether your prescription includes an MAOI, please consult your doctor or pharmacist.
While using this product, it is important not to exceed the recommended dosage. Doing so can lead to serious health risks, including potential misuse or dependence (a condition where your body becomes reliant on a substance). Always prioritize your safety and well-being by following these guidelines.
Side Effects
If you experience nervousness, dizziness, or sleeplessness while using this medication, it's important to stop using it and consult your doctor. Additionally, if your symptoms do not improve within 7 days or if you develop a fever, seek medical advice.
You should not use this medication if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of drug used for depression, psychiatric conditions, or Parkinson’s disease. It's also advised to wait at least 2 weeks after stopping an MAOI before using this product. If you're unsure whether your prescription includes an MAOI, please check with your doctor or pharmacist.
Warnings and Precautions
You should not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, certain psychiatric conditions, or Parkinson’s disease. Additionally, you must wait at least two weeks after stopping an MAOI before using this product. If you are unsure whether your medication contains an MAOI, please consult your doctor or pharmacist.
Before using this product, it’s important to talk to your doctor if you have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland. If you experience an overdose, seek emergency medical help or contact a Poison Control Center immediately.
You should stop using this product and call your doctor if you experience nervousness, dizziness, or sleeplessness, or if your symptoms do not improve within seven days or occur with a fever.
Overdose
If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.
Always err on the side of caution—if you or someone else is experiencing concerning symptoms after taking medication, don’t hesitate to get help right away. Your safety is the top priority.
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.
Pediatric Use
If you have a child under 12 years old, it's important to consult with a doctor before giving them this medication. For children aged 12 and older, the recommended dosage is one tablet every four hours, but be sure not to exceed six tablets in a 24-hour period. Always follow these guidelines to ensure the safety and well-being of your child.
Geriatric Use
If you are an older adult or caring for one, it's important to consult a doctor before using this medication, especially if you have any of the following health conditions: heart disease, diabetes, thyroid disease, high blood pressure, or trouble urinating due to an enlarged prostate. These conditions can affect how the medication works in your body and may require special consideration or adjustments to your treatment plan. Always prioritize open communication with your healthcare provider to ensure safe and effective use of any medication.
Renal Impairment
If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.
Hepatic Impairment
If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (issues with liver function).
Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.
Drug Interactions
It's important to be cautious about combining medications. If you are currently taking a prescription monoamine oxidase inhibitor (MAOI), which is a type of medication used for depression, certain psychiatric conditions, or Parkinson’s disease, you should not use this product. Additionally, you should wait at least two weeks after stopping an MAOI before starting this medication. If you're unsure whether your current prescription includes an MAOI, please consult your doctor or pharmacist for clarification.
Always discuss any medications you are taking with your healthcare provider to ensure your safety and avoid potentially harmful interactions. Your health is a priority, and your provider can help you navigate any concerns.
Storage and Handling
To ensure the safety and effectiveness of your product, store it at room temperature, ideally around 25°C (77°F). It’s acceptable for the temperature to vary between 15°C and 30°C (59°F to 86°F). Always check the end flap of the package for the expiration date and lot number, as this information is important for tracking and safety.
When handling the product, be cautious not to use it if the outer package is opened or if the blister is torn or broken, as this indicates that the product may have been tampered with. Following these guidelines will help you use the product safely and effectively.
Additional Information
You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 1 tablet every 4 hours, but do not exceed 6 tablets in a 24-hour period. If the patient is under 12 years old, it’s important to consult a doctor for the appropriate dosage.
FAQ
What is equate™ used for?
Equate™ is a non-drowsy nasal decongestant that temporarily relieves nasal congestion due to the common cold, hay fever, or other upper respiratory allergies.
What is the active ingredient in equate™?
The active ingredient in equate™ is Phenylephrine HCl 10 mg.
How should I take equate™?
Adults and children 12 years and over should take 1 tablet every 4 hours, not exceeding 6 tablets in 24 hours. Children under 12 years should ask a doctor.
Are there any warnings associated with equate™?
Do not use equate™ if you are taking a prescription monoamine oxidase inhibitor (MAOI) or for 2 weeks after stopping an MAOI. Consult a doctor or pharmacist if unsure.
What should I do if I experience side effects?
Stop using equate™ and ask a doctor if you experience nervousness, dizziness, or sleeplessness, or if symptoms do not improve within 7 days or occur with fever.
Is there a satisfaction guarantee for equate™?
Yes, there is a satisfaction guarantee; if you are not satisfied, you can get a replacement or your money back.
How should I store equate™?
Store equate™ at 25°C (77°F), with permitted excursions between 15°-30°C (59°-86°F).
What should I do in case of overdose?
In case of overdose, get medical help or contact a Poison Control Center immediately.
Can I use equate™ if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, ask a health professional before using equate™.
Packaging Info
Below are the non-prescription pack sizes of Sinus Congestion Pe (phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated | 10 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 | 10 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 Sinus Congestion Pe, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
equate™ is a nasal decongestant containing 10 mg of phenylephrine HCl as the active ingredient. Each package contains 24 tablets, with a strength of 10 mg per tablet. The product is distributed by Walmart Inc., located in Bentonville, AR 72716. It is important to note that this product is not manufactured or distributed by Johnson & Johnson Corporation, the owner of the registered trademark SUDAFED PE® SINUS CONGESTION. The product is sourced from China, India, and Taiwan. A tamper evident warning is included, stating: "DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING." The National Drug Code (NDC) for this product is 79903-076-23.
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
Adults and children aged 12 years and over are advised to take 1 tablet every 4 hours as needed. The maximum recommended dosage is 6 tablets within a 24-hour period.
For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.
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 a period of 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
It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.
Warnings The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this product should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.
General Precautions Prior to using this product, patients should seek medical advice if they have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty in urination due to prostate gland enlargement. These conditions may necessitate careful consideration and monitoring during treatment.
Emergency Medical Help In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center without delay.
Discontinuation and Consultation Patients are advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within seven days or are accompanied by fever, medical advice should be sought promptly.
Side Effects
Patients should discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, medical advice should be sought.
It is contraindicated to use this product in conjunction with a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Furthermore, patients should refrain from using this product for at least 2 weeks after discontinuing an MAOI. If there is uncertainty regarding whether a prescription medication contains an MAOI, patients are advised to consult a doctor or pharmacist prior to use.
Drug Interactions
The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson’s disease. Patients should not take this product while on MAOIs or for a minimum of two weeks following the discontinuation of an MAOI.
It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, if there is any uncertainty regarding the presence of an MAOI in their current prescription medications before initiating treatment with this product.
Packaging & NDC
Below are the non-prescription pack sizes of Sinus Congestion Pe (phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated | 10 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 | 10 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 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period.
Geriatric Use
Elderly patients should consult a healthcare provider prior to using this medication if they have a history of heart disease, diabetes, thyroid disease, high blood pressure, or experience difficulty in urination due to prostate gland enlargement. These conditions may necessitate careful monitoring and potential dose adjustments to ensure safety and efficacy in this population. It is essential for healthcare providers to evaluate the overall health status and comorbidities of geriatric patients to mitigate risks associated with the use of this medication.
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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.
Lactation
Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.
Overdosage
In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.
Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.
Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.
It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.
Nonclinical Toxicology
If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.
Postmarketing Experience
No postmarketing experience details are available in the insert text.
Patient Counseling
Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is crucial to inform patients that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should be instructed to refrain from using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist.
Patients should be informed to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and seek medical advice if their symptoms do not improve within seven days or if they experience symptoms accompanied by fever.
It is important to emphasize to patients the necessity of adhering to the recommended dosage and not exceeding it. Healthcare providers should also recommend that patients consult with a doctor prior to use if they have any of the following conditions: heart disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland.
Storage and Handling
The product is supplied in tamper-evident packaging. It should not be used if the outer package is opened or if the blister is torn or broken.
Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). Healthcare professionals are advised to check the end flap of the packaging for the expiration date and lot number to ensure product integrity and safety.
Additional Clinical Information
The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours, with a maximum of six tablets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor for appropriate dosing guidance.
No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.
Drug Information (PDF)
This file contains official product information for Sinus Congestion Pe, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.