Medi-first Sinus Decongestant

Medi-first Sinus Decongestant
SPL v14
SPL
SPL Set ID 9654f5cd-74d7-44a2-9674-666d1e94ffa7
Route
ORAL
Published
Effective Date 2021-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (10 mg)
Inactive Ingredients
Cellulose, Microcrystalline Propylene Glycol Croscarmellose Sodium Fd&c Red No. 40 Fd&c Yellow No. 6 Lactose Magnesium Stearate Polyethylene Glycol, Unspecified Silicon Dioxide Titanium Dioxide Hypromelloses

Identifiers & Packaging

Pill Appearance
Imprint: 272 Shape: round Color: red Size: 7 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2008-12-30

Description

Active ingredient (in each tablet) Phenylephrine HCl 10 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

Temporarily relieves

■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies

■ sinus congestion and pressure

Dosage and Administration

Directions

  • do not use more than directed

Adults and children: (12 years and older) Take 1 tablet every 4 hours. Do not take more than 6 doses in 24 hours.

Children under 12 years: Ask a doctor

Description

Active ingredient (in each tablet) Phenylephrine HCl 10 mg

Section 42229-5

Other information

  • store at room temperature 59º-86º F (15º-30º C)
  • tamper evident sealed packets
  • do not use any opened or torn packets
Section 50565-1

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by fever
Section 50567-7

When using this product

  • do not exceed recommended dosage
Section 50569-3

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Section 50570-1

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.
Section 51727-6

Inactive ingredients

croscarmellose sodium, FD&C red #40, FD&C yellow # 6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide

Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

Section 55105-1

Purpose

Nasal decongestant

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Medi First Sinus Decongestant Label

100 Tablets

(100 x 1)

Medi-First®

Sinus Decongestant

Compare active ingredients to:

Sudafed® PE

Registered Trademark of Pfizer Consumer

Nasal Decongestant ● Phenylephrine HCl 10mg

Tamper Evident Unit Dose Packets

Medi First Plus Sinus Decongestant Label

100 Tablets

(100 x 1's)

Medi-First® Plus

Sinus Decongestant

Phenylephrine HCl 10mg

Pull To Open

Pseudoephedrine Free

Sinus Relief

Compare active ingredient to:

Sudafed PE®

Registered Trademark of McNeil Consumer Healthcare

Tamper Evident Unit Dose Packets


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves

■ nasal congestion due to the common cold, hay fever or other upper respiratory allergies

■ sinus congestion and pressure

Dosage and Administration (34068-7)

Directions

  • do not use more than directed

Adults and children: (12 years and older) Take 1 tablet every 4 hours. Do not take more than 6 doses in 24 hours.

Children under 12 years: Ask a doctor

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Other information

  • store at room temperature 59º-86º F (15º-30º C)
  • tamper evident sealed packets
  • do not use any opened or torn packets
Section 50565-1 (50565-1)

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • symptoms do not improve within 7 days or are accompanied by fever
Section 50567-7 (50567-7)

When using this product

  • do not exceed recommended dosage
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
Section 50570-1 (50570-1)

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.
Section 51727-6 (51727-6)

Inactive ingredients

croscarmellose sodium, FD&C red #40, FD&C yellow # 6, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, silicon dioxide, titanium dioxide

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Nasal decongestant

Drug Facts

Active ingredient (in each tablet)

Phenylephrine HCl 10 mg

Medi First Sinus Decongestant Label (Medi-First Sinus Decongestant Label)

100 Tablets

(100 x 1)

Medi-First®

Sinus Decongestant

Compare active ingredients to:

Sudafed® PE

Registered Trademark of Pfizer Consumer

Nasal Decongestant ● Phenylephrine HCl 10mg

Tamper Evident Unit Dose Packets

Medi First Plus Sinus Decongestant Label (Medi-First Plus Sinus Decongestant Label)

100 Tablets

(100 x 1's)

Medi-First® Plus

Sinus Decongestant

Phenylephrine HCl 10mg

Pull To Open

Pseudoephedrine Free

Sinus Relief

Compare active ingredient to:

Sudafed PE®

Registered Trademark of McNeil Consumer Healthcare

Tamper Evident Unit Dose Packets


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)