Medi-first Sinus Pain And Pressure

Medi-first Sinus Pain And Pressure
SPL v15
SPL
SPL Set ID 8aa33e28-f1d4-42f0-a334-bf85a779fe3f
Route
ORAL
Published
Effective Date 2021-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Phenylephrine (5 mg)
Inactive Ingredients
Stearic Acid Cellulose, Microcrystalline Fd&c Blue No. 1 Povidone Sodium Starch Glycolate Type A Corn Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: FR;33 Shape: round Color: blue Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2008-12-30

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Indications and Usage

Uses

temporarily relieves these common cold/flu symptoms:

  • nasal congestion
  • headache
  • minor aches and pains
  • stuffy nose
  • sinus congestion and pressure

temporarily reduces fever

Dosage and Administration

Directions

  • do not use more than directed

Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Ask adoctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • 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 appear

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

Ask a doctor before use if you have

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

Do not use

  • 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.
  • for more than 10 days for pain unless directed by a doctor
Section 51727-6

Inactive ingredients corn starch, crospovidone*, FD&C blue #1*, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, pregelatinized starch*, sodium starch glycolate*, stearic acid.

*may contain

Section 53413-1

Questions or comments? 1-800-634-7680

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Nasal decongestant

Section 55106-9

Active ingredients (in each tablet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

Section 60561-8

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper evident sealed packets
  • do not use any opened or torn packets
  • avoid excessive heat and humidity
Otis Clapp Mygrex Label

Otis Clapp

Quality and Integrity Since 1840

MYGREX ™

Pain Reliever-Decongestant

Advanced Relief

For Sinus/Headaches

See Warnings and Directions on Side Panel

This Package is for Households without Young Children.

Acetaminophen 500 mg • Aches & Fever

Phenylephrine HCl 5 mg • Nasal Decongestant

Tear Out Along Perforation To Dispense

PROFESSIONAL HEALTHCARE

300 Tablets (150 PACKETS OF 2)

Medi First Sinus Pain and Pressure Label

250 Tablets

(125 x 2)

Medi-First ®

Sinus Pain and Pressure

Alivio al dolor y presion en los

senos nasales

Pull to Open

Tire Para Abrir

Aches & Fever • Acetaminophen 500 mg

Dolores, Fiebre • Acetaminofeno 500 mg

Nasal Decongestant • Phenylephrine HCl 5 mg

Descongestivo nasal • Hidrocloruro de fenilefrina 5 mg

This Package is For Households Without Young Children.

Este Paquete Es Para Hogares Sin Ninos Pequenos.

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Rvidente en Dosis Unitarias

Medi First Plus Sinus Pain and Pressure Label

100 Tablets

(50 x 2's)

Medi First ® Plus

Sinus Pain and Pressure

Aches & Fever • Acetaminophen 500 mg

Nasal Decongestant • Phenylephrine HCl 5 mg

Pull to Open

This Package is For Households Without Young Children.

Sinus Pain Releif

Tamper Evident

Unit Dose Packets


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves these common cold/flu symptoms:

  • nasal congestion
  • headache
  • minor aches and pains
  • stuffy nose
  • sinus congestion and pressure

temporarily reduces fever

Dosage and Administration (34068-7)

Directions

  • do not use more than directed

Adults and children: (12 years and over) Take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours.

Children under 12 years: Ask adoctor

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • 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 appear

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)

Ask a doctor before use if you have

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

Do not use

  • 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.
  • for more than 10 days for pain unless directed by a doctor
Section 51727-6 (51727-6)

Inactive ingredients corn starch, crospovidone*, FD&C blue #1*, hypromellose*, microcrystalline cellulose, polyethylene glycol*, povidone, pregelatinized starch*, sodium starch glycolate*, stearic acid.

*may contain

Section 53413-1 (53413-1)

Questions or comments? 1-800-634-7680

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Nasal decongestant

Section 55106-9 (55106-9)

Active ingredients (in each tablet)

Acetaminophen 500mg

Phenylephrine HCl 5mg

Section 60561-8 (60561-8)

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper evident sealed packets
  • do not use any opened or torn packets
  • avoid excessive heat and humidity
Otis Clapp Mygrex Label

Otis Clapp

Quality and Integrity Since 1840

MYGREX ™

Pain Reliever-Decongestant

Advanced Relief

For Sinus/Headaches

See Warnings and Directions on Side Panel

This Package is for Households without Young Children.

Acetaminophen 500 mg • Aches & Fever

Phenylephrine HCl 5 mg • Nasal Decongestant

Tear Out Along Perforation To Dispense

PROFESSIONAL HEALTHCARE

300 Tablets (150 PACKETS OF 2)

Medi First Sinus Pain and Pressure Label (Medi-First Sinus Pain and Pressure Label)

250 Tablets

(125 x 2)

Medi-First ®

Sinus Pain and Pressure

Alivio al dolor y presion en los

senos nasales

Pull to Open

Tire Para Abrir

Aches & Fever • Acetaminophen 500 mg

Dolores, Fiebre • Acetaminofeno 500 mg

Nasal Decongestant • Phenylephrine HCl 5 mg

Descongestivo nasal • Hidrocloruro de fenilefrina 5 mg

This Package is For Households Without Young Children.

Este Paquete Es Para Hogares Sin Ninos Pequenos.

Tamper Evident Unit Dose Packets

Empaquetado con Sellado Rvidente en Dosis Unitarias

Medi First Plus Sinus Pain and Pressure Label (Medi-First Plus Sinus Pain and Pressure Label)

100 Tablets

(50 x 2's)

Medi First ® Plus

Sinus Pain and Pressure

Aches & Fever • Acetaminophen 500 mg

Nasal Decongestant • Phenylephrine HCl 5 mg

Pull to Open

This Package is For Households Without Young Children.

Sinus Pain Releif

Tamper Evident

Unit Dose Packets


Advanced Ingredient Data


Raw Label Data

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