Sudafed Pe Sinus Congestion
diphenhydramine hydrochloride and phenylephrine hydrochloride · Kit · Oral
Active ingredient
Active ingredient (in each tablet) Phenylephrine HCl 10 mg Active ingredients (in each tablet) Purpose Diphenhydramine HCl 25 mg Antihistamine Phenylephrine HCl 10 mg Nasal decongestant
Purpose
Purpose Nasal decongestant Active ingredients (in each tablet) Purpose Diphenhydramine HCl 25 mg Antihistamine Phenylephrine HCl 10 mg Nasal decongestant
Uses
Uses temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat nasal congestion temporarily relieves these symptoms due to the common cold: runny nose sneezing nasal congestion temporarily relieves sinus congestion and pressure
Warnings
Warnings 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 diabetes 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 occur symptoms do not improve within 7 days or occur with a fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin 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 diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not exceed recommended dose marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Do not use
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. Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin 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
Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
When using this product do not exceed recommended dose When using this product do not exceed recommended dose marked drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children
Stop use and ask a doctor
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with a fever
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use. If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
Directions adults and children 12 years and over take 1 tablet every 4 hours do not take more than 6 tablets in 24 hours children under 12 years ask a doctor Directions adults and children 12 years and over take 1 tablet every 4 hours do not take more than 6 tablets in 24 hours children under 12 years ask a doctor
Other information
Other information store between 20-25°C (68-77°F) do not use if blister unit is torn or broken Other information store between 20-25°C (68-77°F) do not use if blister unit is torn or broken
Inactive ingredients
Inactive ingredients carnauba wax, D&C yellow no. 10 aluminum lake, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide Inactive ingredients carnauba wax, FD&C blue no. 1 aluminum lake, magnesium stearate, microcrystalline cellulose, modified starch, polyethylene glycol, polyvinyl alcohol, powdered cellulose, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide
Questions?
Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect) Questions or comments? call 1-888-217-2117 (toll-free) or 215-273-8755 (collect)
Label text from the FDA structured product label by Kenvue Brands LLC (revised Nov 8, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Phenylephrine Hydrochloride in 1 product
Sudafed Pe Sinus Congestion NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50580-239 | Kit | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
| 50580-437 | Phenylephrine Hydrochloride 10 mg/1 Tablet, Film Coated | Kenvue Brands LLC | OTC MONOGRAPH DRUG |
Frequently asked questions
What is Sudafed Pe Sinus Congestion used for?
Uses temporarily relieves sinus congestion and pressure temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat nasal congestion temporarily relieves these symptoms due to the…
Who makes Sudafed Pe Sinus Congestion?
Sudafed Pe Sinus Congestion is listed by 1 labeler in the FDA NDC directory, including Kenvue Brands LLC.