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Principal Display Panel
SPL v3
SPL
SPL Set ID a616996f-a496-b0fb-e053-2995a90a9e96
Route
ORAL
Published
Effective Date 2021-11-09
Document Type 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

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