Principal Display Panel
a616996f-a496-b0fb-e053-2995a90a9e96
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Medication Information
Indications and Usage
temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: sinus congestion and pressure headache minor aches and pains nasal congestion promotes sinus drainage temporarily reduces fever
Dosage and Administration
do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years ask a doctor
Description
Drug Facts
Section 42229-5
Drug Facts
Section 44425-7
store between 20-25ºC (68-77ºF) in a dry place retain carton for complete product information and warnings
Section 50566-9
nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition.
Section 50567-7
When using this product do not exceed recommended dosage
Section 50568-5
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Section 50569-3
liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland
Section 50570-1
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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. if you have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6
colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, FD & C yellow #6 aluminum lake, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Section 51945-4
NDC 41250-207-06 Compare to Sudafed PE® Sinus Pressure + Pain active ingredients† meijer® NON-DROWSY sinus pressure & pain PE Acetaminophen | Phenylephrine HCl Pain Reliever/Fever Reducer, Nasal Decongestant MAXIMUM STRENGTH Relief ofL Sinus Headache; Sinus Pressure & congestion 24 CAPLETS actual size
Section 53413-1
1-844-705-4384
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Phenylephrine HCl 5 mg Nasal decongestant
Structured Label Content
Indications and Usage (34067-9)
temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: sinus congestion and pressure headache minor aches and pains nasal congestion promotes sinus drainage temporarily reduces fever
Dosage and Administration (34068-7)
do not take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years ask a doctor
Section 42229-5 (42229-5)
Drug Facts
Section 44425-7 (44425-7)
store between 20-25ºC (68-77ºF) in a dry place retain carton for complete product information and warnings
Section 50566-9 (50566-9)
nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition.
Section 50567-7 (50567-7)
When using this product do not exceed recommended dosage
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Section 50569-3 (50569-3)
liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland
Section 50570-1 (50570-1)
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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. if you have ever had an allergic reaction to this product or any of its ingredients
Section 51727-6 (51727-6)
colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, FD & C yellow #6 aluminum lake, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Section 51945-4 (51945-4)
NDC 41250-207-06 Compare to Sudafed PE® Sinus Pressure + Pain active ingredients† meijer® NON-DROWSY sinus pressure & pain PE Acetaminophen | Phenylephrine HCl Pain Reliever/Fever Reducer, Nasal Decongestant MAXIMUM STRENGTH Relief ofL Sinus Headache; Sinus Pressure & congestion 24 CAPLETS actual size
Section 53413-1 (53413-1)
1-844-705-4384
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Section 55105-1 (55105-1)
Active ingredients (in each caplet) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Phenylephrine HCl 5 mg Nasal decongestant
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:03:46.080706 · Updated: 2026-02-15T12:03:45.686569