publix super markets, inc. nasal decongestant pe drug facts

publix super markets, inc. nasal decongestant pe drug facts
SPL v5
SPL
SPL Set ID 3ea6dfa8-9865-4f23-bc9f-101f5f36e0ac
Route
oral
Published
Effective Date 2022-05-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Purpose

Nasal decongestant

Description

Phenylephrine HCl 10 mg


Medication Information

Active Ingredient

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
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

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

Description

Phenylephrine HCl 10 mg

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

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.

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).

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

Active Ingredient (Active ingredient (in each tablet))

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
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

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

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.

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).

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


Raw Label Data

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