Publix Super Markets, Inc. Nasal Decongestant Pe Drug Facts

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (10 mg)

Inactive Ingredients

Carnauba Wax Anhydrous Dibasic Calcium Phosphate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Silicon Dioxide Talc Titanium Dioxide Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance

Imprint: L7 Shape: round Color: red Size: 8 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2005-06-10

Medication Information

Purpose

Nasal decongestant

Description

Phenylephrine HCl 10 mg

Uses

•
temporarily relieves sinus congestion and pressure
•
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

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

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.

Other Information

•
store at 68-77^°F (20-25^°C)
•
do not use if blister unit is broken or torn

Inactive Ingredients

anhydrous dibasic calcium phosphate, carnauba wax, FD&C red no. 40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Principal Display Panel

P

NON-DROWSY

nasal decongestant PE

PHENYLEPHRINE HCl TABLETS – NASAL DECONGESTANT

• Sinus Pressure

• Nasal & Sinus Congestion

ACTUAL SIZE

MAXIMUM STRENGTH

SINUS PE

72 TABLETS 10 mg EACH

Compare to Sudafed PE^® Congestion active ingredient

When Using This Product

do not exceed recommended dosage

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).

Active Ingredient (in Each Tablet)

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have

•
heart disease
•
high blood pressure
•
thyroid disease
•
diabetes
•
trouble urinating due to an enlarged prostate gland

Structured Label Content

Uses

•
temporarily relieves sinus congestion and pressure
•
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies

Purpose

Nasal decongestant

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

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.

Other Information (Other information)

•
store at 68-77^°F (20-25^°C)
•
do not use if blister unit is broken or torn

Inactive Ingredients (Inactive ingredients)

anhydrous dibasic calcium phosphate, carnauba wax, FD&C red no. 40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Principal Display Panel

P

NON-DROWSY

nasal decongestant PE

PHENYLEPHRINE HCl TABLETS – NASAL DECONGESTANT

• Sinus Pressure

• Nasal & Sinus Congestion

ACTUAL SIZE

MAXIMUM STRENGTH

SINUS PE

72 TABLETS 10 mg EACH

Compare to Sudafed PE^® Congestion active ingredient

When Using This Product (When using this product)

do not exceed recommended dosage

Stop Use and Ask A Doctor If (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, (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).

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Phenylephrine HCl 10 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

•
heart disease
•
high blood pressure
•
thyroid disease
•
diabetes
•
trouble urinating due to an enlarged prostate gland

Advanced Ingredient Data

[{"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS DIBASIC CALCIUM PHOSPHATE", "unii": "L11K75P92J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "• temporarily relieves sinus congestion and pressure • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies", "Purpose": "Nasal decongestant", "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", "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.", "Other information": "• store at 68-77 ° F (20-25 ° C) • do not use if blister unit is broken or torn", "Inactive ingredients": "anhydrous dibasic calcium phosphate, carnauba wax, FD&C red no. 40 aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide", "Principal Display Panel": "P NON-DROWSY nasal decongestant PE PHENYLEPHRINE HCl TABLETS – NASAL DECONGESTANT • Sinus Pressure • Nasal & Sinus Congestion ACTUAL SIZE MAXIMUM STRENGTH SINUS PE 72 TABLETS 10 mg EACH Compare to Sudafed PE ® Congestion active ingredient", "When using this product": "do not exceed recommended dosage", "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).", "Active ingredient (in each tablet)": "Phenylephrine HCl 10 mg", "Ask a doctor before use if you have": "• heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland"}

Publix Super Markets, Inc. Nasal Decongestant Pe Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information