Mckesson Sinus Pain And Pressure Relief

Mckesson Sinus Pain And Pressure Relief
SPL v3
SPL
SPL Set ID e0cbb213-4f4f-4045-e053-2a95a90a2a18
Route
ORAL
Published
Effective Date 2022-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Acetaminophen (500 mg)
Inactive Ingredients
Povidone Hypromellose, Unspecified Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Stearic Acid Starch, Corn Crospovidone

Identifiers & Packaging

Pill Appearance
Imprint: AZ;261 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-09-01

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 a doctor

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

Over dose 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 unless directed by a doctor
Section 51727-6

Inactive imgredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid.

Section 51945-4

McKesson

Sinus Pain and Pressure Relief

Acetaminophen 500 mg | Phenylephrine HCl 5 mg

NDC 68599-4751-3

This Package is for Households without Young Children.

Non-aspirin pain relief and pseudoephrine-free sinus decongestant.

Section 53413-1

Questions or comments? C all 1-800-777-4908

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

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 a doctor

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.

Over dose 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 unless directed by a doctor
Section 51727-6 (51727-6)

Inactive imgredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid.

Section 51945-4 (51945-4)

McKesson

Sinus Pain and Pressure Relief

Acetaminophen 500 mg | Phenylephrine HCl 5 mg

NDC 68599-4751-3

This Package is for Households without Young Children.

Non-aspirin pain relief and pseudoephrine-free sinus decongestant.

Section 53413-1 (53413-1)

Questions or comments? C all 1-800-777-4908

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

Advanced Ingredient Data


Raw Label Data

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